NDA Strategic Plan

NATIONAL DRUG AUTHORITY
STRATEGIC AND
IMPLEMENTATION ACTION PLAN
2020/21 – 2024/25
NDA REGULATORY FUNCTIONS
The National Drug Authority (NDA) was established in 1993 by the
National Drug. Policy and Authority Statute, which in 2000 became the
National Drug Policy and Authority (NDPA) Act, Cap.206 of the Laws
of Uganda (2000 Edition).
MANDATE VISION MISSION

To ensure the availability, A world To protect
at all times, of essential, class drug and promote
efficacious and cost-eff regulatory human and
ective drugs to the entire Agency. animal health
population of Uganda through the
as a means of providing effective
satisfactory healthcare regulation of
and safeguarding the drugs and
appropriate use of drugs. healthcare
products.
CORE VALUES CONTRIBUTION TO THE HEALTH

OUTCOMES
• We Care for the
people of Uganda. • Medicines available on the
market are efficacious for stated
• We take Pride in diseases and conditions resulting
in better treatment of illnesses and
what we do
prevention of diseases to protect
• We serve with and promote a healthy population.
Integrity. • Reduced treatment failures
and number of deaths due to
• We value Team substandard, falsely-labelled,
spirit. falsified and counterfeit human/
veterinary drugs.
• We Embrace new • Improved animal health and
knowledge and production to safeguard public
Innovation. health and improved economic
gains for the farmers.
II
Strategic & Implementation Action Plan 2020/21 – 2024/25
NDA REGULATORY FUNCTIONS
a) Deal with the development and regulation of the pharmacies

and drugs in the country;
b) Approve the national list of essential drugs and supervise the
revisions of the list in a manner provided by the Minister;
c) Estimate drug needs to ensure that the needs are met as
economically as possible;
d) Control the importation, exportation and sale of
pharmaceuticals;
e) Control the quality of drugs;
f) Promote and control local production of essential drugs;
g) Encourage research and development of herbal medicines;
h) Promote rational use of drugs through appropriate
professional training;
i) Establish and revise professional guidelines and disseminate
information to health professionals and the public;
j) Provide advice and guidance to the Minister and bodies;
k) Concerned with drugs on the implementation of the national
drug policy; and
l) Perform any other function that is connected with the above
or that may be accorded to it by law.
Citation
This plan and its provisions shall be cited as
“The Strategic Plan 2020/21 - 2024/25”.
III
THE 7TH DRUG AUTHORITY
IV
THE NATIONAL DRUG AUTHORITY

MANAGEMENT TEAM
Dr. David Nahamya

Secretary to the Authority
Dr. Denis Mwesigwa Dr. Juliet Okecho Dr. Helen Ndagije

Director Inspectorate & Director Product Director Product
Enforcement Service Assessment Safety
and Registration
Mr. Rogers Kayita Mr. Wilberforce Kwiringira

Director Corporate Director Laboratory Services
Services
V
Foreword
The National Drug

Authority (NDA) Strategic
Plan, 2020/21 – 2024/25
establishes the medium-
term strategic direction
that looks at attaining and
maintaining global best
practices in drug regulation.
Effective implementation
of this strategic plan will
oversee the expansion of
NDA mandate, facilitate the attainment of the World Health
Organization maturity level 3 which is central to the regulatory
support of the local pharmaceutical industry and the drug
industry globally.
Drugs and healthcare products are a key input for quality

of life and health service delivery to the people of Uganda.
The mandate of NDA has been stretched over years to meet
the ever increasing demands for a range of drugs to address
both existing and emerging health conditions Covid-19
notwithstanding. The regulatory efforts are central to the safety
of the patients and healthcare providers in services of the
Ministry of Health and partners.
VI
I will ensure that as the Ministry we continue to support

investment in health regulatory services that will enhance
the preventive, curative and palliative health interventions for
universal health coverage for the people of Uganda. I also
appeal to all the relevant government Ministries, Departments
and Agencies and the development partners for necessary
support in ensuring that NDA realize the strategic commitments
inline with the National Development Plan III.
For God and my Country.
Dr. Jane Ruth Aceng

MINISTER OF HEALTH
VII
Preface
The Government of
Uganda developed the
National Development
Plan III that focuses on
modern, people centered,
independent, integrated,
resilient and self-sustaining economy. To this end, the
Government aims at increasing household incomes and
improving the quality of life of Ugandans through sustainable
industrialization for inclusive growth, employment and
sustainable wealth creation.
The main goal of this strategic plan is “to attain and

maintain global best practices in drug regulation by 2025”. The
key strategic shifts are aimed at multi-sectoral approach to
drug regulation through greater collaboration and partnership
at sub-national, national, regional and international levels,
self-sustaining local pharmaceutical industry, policy and legal
improvement advocacy and creating awareness of Government
efforts in drug regulation. Our efforts shall complement those
of the Ministry of Health and other health service providers in
health service delivery.
The plan has been developed through a rigorous

stakeholder consultative process that involved key stakeholders,
the Drug Authority members, Management and staff.
VIII
Over the next five years, we will deliver services to our

clients through four carefully determined focus areas that have
been aligned to NDPIII programme approach as below:
1. Core Service Delivery; This focuses on the core functions of

the Drug Authority.
2. Legal and regulatory framework reforms to adequately
deliver regulatory services.
3. Stakeholder awareness, engagement and collaboration to
effectively deliver the regulatory services to our clients.
4. Institutional Development; This is aimed at building Business
Value for NDA and create systems that will ease regulatory
service delivery.
The Drug Authority takes pride in being part of the country’s

regulatory service delivery and pledges full commitment towards
the implementation of this strategic plan.
Dr. Medard Bitekyerezo

CHAIRPERSON, NATIONAL DRUG AUTHORITY
IX
Message from
the Secretary
to the Authority
The National Drug

Authority Strategic Plan
2020/2021-2024/2025
builds on the gains achieved
in the previous period and
also focuses on consolidating
efficiency and effectiveness in
drug regulation, as provided
for within the mandate of the Drug Authority. This strategic plan
has been aligned to the NDPIII programmes of Human Capital
Development, Manufacturing, Agro-Industrialization, and
Private Sector Development. We have aligned the stakeholder
expectations to the key focus areas as articulated by the
Chairperson of the Drug Authority.
This strategic plan comes at a time when the world

is engulfed in the Covid-19 pandemic that has ravaged
the economies of the world and affected NDA’s effective
implementation of drug regulation. Some of the challenges
include: inability to conduct Good Manufacturing Practice
Inspections of the global manufacturers of drugs; Post Market
Surveillance of the drugs on the market; Drug use and the
possible anti-microbial resistance as a result of lockdown and
self-medication by the population and Staffing levels which has
affected the regulatory operational efficiency and effectiveness.
Amidst all this, we were able to find opportunity to demonstrate
our innovation, leadership and commitment to the highest
standards of service delivery in drugs regulation.
X
I must note that the pandemic has presented a number of

opportunities through promoting more domestic pharmaceutical
industrialization that resonates well with NDPIII aspiration
in industrialization and employment, local pharmaceutical
research innovations and more focus on preventive approach
to health service delivery, to limit the spread of the Covid-19
pandemic.
The Management of NDA assures the public that we will

harness the regulatory dividends so far achieved and focus on
policy advocacy, strengthening the enforcement of the NDP&A
Act and regulations by ensuring greater regulatory compliance,
enhance collaboration and partnership at sub-national, national,
regional and international levels in delivering the NDA mandate
as enshrined in law to ensure safety, efficacy, and quality of
drugs for both human and animal health.
The Management and Staff of NDA commit to the

successful implementation of this Strategic Plan together with
our key stakeholders and partners to serve our clients better.
We also commit to report on progress to the Drug Authority
and our stakeholders regularly, not only as a good corporate
governance practice but also as part of being accountable to
the people of Uganda.
David Nahamya
SECRETARY TO THE AUTHORITY
XI
Acknowledgement
National Drug Authority would like to appreciate our key

stakeholders, the members of the Drug Authority, Management
and staff, World Health Organization and National Planning
Authority who contributed to the development of this strategic
plan. The Drug Authority is greatly indebted to you all for the
time, effort and ideas invested in the development of this
Strategic Plan.
Special thanks go to the following individuals that

supported the development of this Strategic Plan:
Dr. Joseph Mwoga

World Health Organization
Dr. Sarah Nahalamba Birungi

Manager Population and Social Sector Planning, National
Planning Authority
Dr. Joseph Muvawala

Executive Director, National Planning Authority
XII
National Drug Authority Ultra Modern Laboratory Tower.
XIII
List of Abbreviations
ADR Adverse Drug Reaction

AfCFTA African Continental Free Trade Area
AMA African Medicines Agency
AMR Antimicrobial Resistance
API Active Pharmaceutical Ingredient
DP&NM Department of Pharmaceuticals and Natural
Medicines
EAC East African Community
EMHS Essential Medicines and Health Supplies
FY Financial Year
GDP Gross Domestic Product
GMP Good Manufacturing Practices
GoU Government of Uganda
HCs Health Centres
HSDP Health Sector Development Plan
IGAD Inter Government Agency for Development
KPI Key Performance Indicators
MAAIF Ministry of Agriculture Animal Industry and
Fisheries
MDAs Ministries, Departments and Agencies
M&E Monitoring and Evaluation
MOH Ministry of Health
NCDs Non-communicable Diseases
NCRI Natural Chemotherapeutic Research Institute
W.R.T With Respect To
NDA National Drug Authority
NDP/A National Development Plan Act
XIV
NDQCL National Drug Quality Control Lab

NESW National Electronic Single Window
NIRA National Identification AND Registration Authority
NMP National Medicines Policy
NPSSP National Pharmaceutical Sector Strategic Plan
NVDP National Veterinary Drug Policy
PD Pharmacy Division
PHP Private Health Providers
PNFP Private Not-For-Profit
PSU Pharmaceutical Society of Uganda
RCOREs Regional Centres of Regulatory Excellence
RDU Rational Drug Use
SDGs Sustainable Development Goals
SDT Service Delivery Timelines
SSFFC Substandard/Spurious/Falsely labelled/Falsified/
Counterfeit
TCMs Traditional and complementary medicines
UBOS Uganda Bureau of Standards
UCC Uganda Communication Commission
UFDA Uganda Food and Drugs Act
UHC Universal Health Care
UNCST Uganda, Uganda National Council for Science and
Technology
UNHRO Uganda National Health Research Organisation
VET Veterinary
WHO World Health Organisation
XV
Table of Contents
EXECUTIVE SUMMARY ....................................................................................................... XIX

1.0 CHAPTER ONE: INTRODUCTION ........................................................... 1
1.1 Background .............................................................................................................................. 1
1.2 The Legal Framework of NDA .............................................................................. 1
1.3 Governance and Organizational Structure ............................................ 2
1.4 The National Legal and Policy Context of NDA ................................. 2
1.5 Purpose of the Plan .......................................................................................................... 3
1.6 The Process of Developing the Strategic Plan ................................... 4
1.7 The structure of the MDA Strategic Plan .................................................. 5
2.0 CHAPTER TWO: SITUATIONAL ANALYSIS .............................. 6

2.1 Health Sector .......................................................................................................................... 7
2.2 Performance of the NDA Strategic Plan 2015/16
- 2019/20 Evaluation .................................................................................................. 14
2.3 Stakeholder Analysis, Expectations and Aspirations ............. 23
2.4 SWOT Analysis .................................................................................................................. 30
2.5 Organizational Structural Analysis ............................................................... 37
2.6 Critical Gaps and Emerging Issues,
Recommendations and Interventions ..................................................... 37
2.7 The Significant Unfinished Priorities from
Previous Strategic Plan ............................................................................................ 39
XVI
3.0 CHAPTER THREE: STRATEGIC DIRECTION ...................... 40

3.1 Preamble .................................................................................................................................. 41
3.2 Rationale for National Drug Authority
Strategic Plan 2020-2025 .................................................................................... 42
3.3 Vision ............................................................................................................................................ 42
3.4 Mission ....................................................................................................................................... 42
3.5 Core Values ........................................................................................................................... 43
3.6 Goal ................................................................................................................................................ 43
3.7 Strategic Objectives ..................................................................................................... 43
3.8 Strategy Slogan ................................................................................................................ 47
3.9 Linkage of the NDA Strategic Plan to NDP III .................................. 47
3.11 Strategic Objectives and Expected Outcomes ........................... 53
4.0 CHAPTER FOUR: FINANCING OF THE PLAN .................... 62

4.1 Costing and Financing Framework ............................................................. 63
4.2 The Major Cost Drivers Over the Planning Period ...................... 71
4.3 Key Financial Assumptions .................................................................................. 71
5.0 CHAPTER FIVE: IMPLEMANTATION ARRANGEMENTS

................................................................................................................................................................ 72
5.1 Institutional arrangements for Plan implementation ................. 73
XVII
6.0 CHAPTER SIX COMMUNICATION AND FEEDBACK

MECHANISM ................................................................................................................... 78
6.1 Objectives of the communication and feedback
mechanism ............................................................................................................................ 79
6.2 Dissemination methods ........................................................................................... 80
6.3 Mechanisms for generating feedback from stakeholders ..... 80
7.0 CHAPTER SEVEN: MONITORING AND

EVALUATION ARRANGEMENTS ........................................................ 82
7.1 Progress Reporting and Review of Results ....................................... 83
7.2 Monitoring and Evaluation assumptions ............................................... 84
7.3 NDA M&E Results Framework Matrix ...................................................... 85
8.0. CHAPTER EIGHT: ENTERPRISE RISK

MANAGEMENT ............................................................................................................. 90
8.1 Risk Management Introduction ....................................................................... 91
8.2 Risk Profile .............................................................................................................................. 93
8.3 Summary Matrix of Key NDA Envisaged Risks ........................... 93
9.0 CHAPTER NINE: PROJECT PROFILES ................................... 100
Annexes .................................................................................................................................................... 104

Annex 1: Detailed Output Level Result framework ....................................... 104
Annex 2: COST IMPLEMENTATION MATRIX ..................................................... 168
Annex 3: Organogram ................................................................................................................. 180
Annex 4: Key NDA Envisaged Risk Matrix ............................................................. 182
XVIII
EXECUTIVE SUMMARY
The NDA Strategic Plan 2020-2025 has been developed

as a drugs and healthcare products regulatory contribution
to Vision 2040 with respect to health - of improving life
expectancy and reducing infant mortality; NDP III’s priority on
health - of improving population health. At a regional level, the
SP contributes to achieving harmonization with Chapter 21,
Article 118 (c) – (f) of the EAC; and to SDG 3 - “Ensure healthy
lives and promote well-being for all at all ages.” at the global
level. The interventions in the plan have also been designed
in alignment to the NDP III new programmatic planning and
budgeting framework to optimize NDA’s contribution to the
relevant programmes of the national development plan.
The overall goal of the strategy for this medium term is to

“consolidate efficiency and effectiveness in drugs regulation.”
The strategy has been informed by stakeholder expectations of
NDA over the next five years; the need to contribute to attainment
of national development priorities in Uganda’s Vision 2040
and National Development Plan III; as well as emerging drugs
regulation harmonization issues at the regional, continental and
global levels. In the context of this overall goal, the new strategic
agenda focuses on four Areas: (i) Core Service Delivery (ii) Legal
and Regulatory framework; (iii) Stakeholder engagement and
Collaboration and (iv) Institutional development.
XIX
Four strategic objectives have been developed, one for

each NDA Focus Area area to be pursued during the 5-year
horizon. These shall include the following;
1. To improve the regulatory efficiency and effectiveness

that ensure safe, efficacious and quality drugs and health
products.
2. To Streamline the legal and regulatory framework for
operational effectiveness of NDA.
3. To increase stakeholder awareness, engagement and
collaboration to support NDA regulatory functions.
4. To improve NDA institutional capacity to effectively and
efficiently implement its functions.
In accordance with these objectives, NDA expects to realize the fol-
lowing outcomes;
1. Improved regulatory systems, processes and procedures
that guarantee availability of safe, efficacious and quality
drugs and health products.
2. Improved public access and utilization of safe, efficacious
and quality drugs and health products.
3. Harmonized legislative framework that enables an effective
and well-functioning regulatory system for drugs and health
products.
4. Increased public awareness, knowledge and practices
about safety, efficacy and quality of drugs.
5. Increased positive perception and visibility of NDA as an
effective global standard regulator within the health system.
6. Improved institutional infrastructure to enable effective
regulatory service delivery and specialized operations.
XX
7. Enhanced digital transformation for regulatory effectiveness.

8. Increased human resource productivity to deliver the NDA’s
regulatory mandate.
9. Improved financial sustainability of NDA.
A Monitoring and Evaluation Plan has been put in place

to track the performance of the Strategic Plan on all outcome
and key output indicators, installation of an M&E database has
been recommended to render reporting and feedback real-
time. Risk management has also been incorporated in the
implementation modalities of the plan in a bid to harmonize
with the Government of Uganda Risk Management Strategy
2018.
The strategic plan has been appropriately costed and

the indicative annual budgets for the medium term drawn to
finance the implementation of the plan’s priorities and deliver
on the planned actions. The required funds to finance this plan
will amount to UGX, 485. 322.Bn (four hundred eighty-five
billion three hundred twenty-two million shillings) over the five-
year period.
XXI
1.0 INTRODUCTION
XXII
1.1 Background
This five-year plan for the period 2020/21-2024/25 builds

on the previous strategic plan, while making effort to align
with the NDP III and WHO policy direction on drugs regulation.
The Vision and Mission have been reviewed to acknowledge
NDAs growing significance and refocused in context of the
emerging stakeholders’ expectations and aspirations. Four
key Focus Areas arising from the emerging expectations of
the stakeholders and developments in the environment that
constitute the strategic plan, have been identified.
1.2 The Legal Framework of NDA
The National Drug Authority was established in 1993 by

the National Drug Policy and Authority Statute which in 2000
became the National Drug Policy and Authority (NDP/A) Act 206
of the Laws of Uganda. Within its legislative mandate, National
Drug Authority is responsible for;
1
1. Development 2. Control the 3. Encourage 4. Promote and 5. Promote rational

and regulation importation, research and control local use of drugs
of the exportation and development of production of through
pharmacies sale of herbal essential drugs appropriate
and drugs in pharmaceuticals medicines; professional
Uganda training;
6. Establish and revise 7. Provide advice and 8. Approve the 9. Estimate

professional guidance to the national list of drug needs to
guidelines and Minister and bodies essential drugs ensure that the
disseminate concerned with drugs and supervise needs are met.
information to health on the implementation the revisions of
professionals and the of the national drug the list,
public, policy,
1.3 Governance and Organizational Structure
National Drug Authority, headed by the Secretary to

Authority, has various directorates to coordinate and meet the
overall drug and health products regulatory objectives of the
institution. These directorates currently include; Directorate of
Product Assessment and Registration, Laboratory Services,
Product Safety, Inspectorate and Enforcement Services and
that of Corporate Services.
1.4 The National Legal and Policy Context of NDA
To consolidate and accelerate the development growth

momentum, the Government of Uganda launched the Vision
2040, to echo its aspiration of transformation to a competitive
upper middle-income country by 2040. Vision 20240 sets
out to achieve this though, strengthening fundamentals for
2
harnessing opportunities, though agriculture, industrialization,

human resource development and science, technology,
engineering and innovation.
This strategic plan is aligned to four NDP III programs and their
respective objectives namely;
• Agro-industrialization Programme Objective 1: Increase
production and productivity:
• Human capital development Programme Objective 4: To
improve population health, safety and management;
• Private sector development Programme Objective 5:
Strengthen the enabling environment and enforcement of
standards, where NDA is contributing to the support of the
Good Manufacturing Practice (GMP) compliance.
• Manufacturing Programme Objective 2: Increase value
addition for import substitution and enhanced exports.
The Plan is aligned to the EAC Vison 2050, by creating a

conducive environment for investment, coupled with effective
institutional capacities, where the region will expand its
production capacity and widen its exports, both by composition
and value.
Finally, it is aligned to Africa Agenda 2063, aspiration 1; of

A prosperous Africa based on inclusive growth and sustainable
development and aspiration 6; An Africa whose development
is people-driven, relying on the potential of African people,
especially its women and youth, and caring for children
1.5 Purpose of the Plan
The primary purpose of the Strategic Plan for NDA is to

develop a comprehensive “Road Map” setting the direction
3
and pace of the institution’s core functions for the next 5 years
against a defined strategic backdrop. This Strategic plan has
been developed as a guiding document to give direction in
the development of strategies to build on the achievements
attained. The plan addresses the challenges and gaps that
have hampered service delivery in last five years. The plan sets
priority in resource allocation and utilization so as to deliver
quality drug and health product regulatory services to the
people of Uganda.
1.6 The Process of Developing the Strategic Plan
The plan has been developed by an internal task force

through a participatory process. The internal task force
comprised of all heads of directorates, and departments
the business development Team and guidance of National
Planning Authority (NPA). As part of the development process,
this combined team held several consultative meetings with
the different stake holders that included The Ministry of Health
(MoH), Ministry of Animal Industries and Fisheries (MAAIF),
Professional Associations, Drug Importers, Pharmacy and drug
shop owners, herbalist and health and vet practitioners. This
Plan seeks to translate NDA’s strategic and investment focus
into concrete investment plans for drug and health products
regulation, physical infrastructure and management support
services.
The process of the plan development involved the

following; a) document review b) rapid assessment of past
strategic plan performance, c) stakeholders’ consultation,
before the Board approved the Plan.
4
1.7 The structure of the MDA Strategic Plan
This plan is divided into nine chapters. Chapter one

presents the background and introduction. Chapter two,
a situational analysis. Chapter three presents an outline of
the strategic direction,. Chapter four; presents the costing
and financing framework. Chapter five outlines the detailed
implementation arrangements. Chapter 6 and 7 respectively
presents the communication and feedback and monitoring,
and evaluation arrangements. The risk management framework
is provided in chapter 8, and chapter 9 presents key project
profiles to be undertaken over the five year period.
5
2.0 SITUATIONAL
ANALYSIS
6
This section reviews changes and developments to drug

regulation in Uganda with the objective of informing the strategic
priorities of the institution for the plan period. A PESTLE analysis
is further undertaken as part of the situational analysis. This
chapter also presents the organizational assessment in terms
of the achievements from the previous strategic plan, a SWOT,
summary of the critical gaps and emerging issues that need to
be addressed and the significant unfinished business from the
previous strategic plan.
2.1 Health Sector

2.1.1 Pharmaceutical Sub-sector
The Government of Uganda (GoU) recognizes health as a

human right. National Drug Authority together with the Ministry
of Health will ascertain that the rights to access quality health
care and health information are respected by all categories
7
of individuals of the society both within the public and private

sector. There shall be a need for increased priority to plan and
provide for better health services in general and better capacity
for medicines regulation in particular in the medium to long-
term. This is the rationale for this NDA Strategic Plan 2021-
2025.
The Ministry of Health (MOH) is responsible for the

overall leadership and governance of the health sector with
responsibilities for policy formulation, strategic direction,
setting standards, disease surveillance, quality assurance, and
resource mobilization.
NDA is a key player in the health sector and pharmaceutical

sub-sector in particular mandated to ensure quality, safety and
efficacy of human and animal drugs in Uganda. MoH through
the Pharmacy Division (MoH/PD), is responsible for the overall
coordination of the sector, as well as for providing oversight for
the NMP implementation.
The health sector budget increased by 9.1% to Ugx 2.589

trillion from Ugx 2.373 trillion in FY 2018/19 though it remained
at 7.2% of the total national budget. Of the Ugx 2.589 trillion
57% was from GoU funding and 43% external funding. Overall,
89% (Ugx 2.4 trillion) of the budget was released compared to
80% in the previous FY1.
Over the outgoing HSDP period, there was an overall

increase in funding for procurement, storage and distribution
of Essential Medicines and Health Supplies (EMHS), both from
government and donors. National forecasts, quantification and
procurement planning for Essential Medicines & Health Supplies
1 Health Sector Performance Report 2019/20
8
(EMHS) and laboratory commodities was regularly done and

disseminated, and programmes to improve rational use of
medicines through the hospital medicines and therapeutics
committees were implemented. In spite of this progress, there
remains a huge and significant need to roll out a reliable logistics
management information system throughout the entire sector
that is interoperable with the Enterprise Resource Planning
Systems at National Medical Store and Joint Medical Stores.
The average availability of a basket of EMHS (% of facilities
that had over 95%) decreased from 52% in FY 2015/16 to
41% in FY 2018/19.
In spite of these investments and achievements,

pharmaceutical space is facing a significant pharmaceutical
human resources challenge to sustain them. District Health
Services do not have established pharmaceutical positions
posing a challenge to service delivery.
Comprehensive post-market surveillance to control

illegal drug outlets and illicit sale of poor-quality drugs needs
continuous and sustained efforts yet it is still far from adequate.
In 2019, there were 1,870 licensed pharmacies and 10,720
licensed drug shops distributed across the country. Despite
the existence of an established regulatory framework with
NDA, there is limited distribution of pharmacies in the rural
communities with an over concentration in urban centers.
Similarly, despite improvement in numbers of licensed drug
shops, there remain many illegal drug shops whose services
require to be regulated.
There is still limited local pharmaceutical production

in Uganda although there has been a marked increase
in the establishment of new manufacturing units for both
9
conventional and herbal medicines during the last five years.

Uganda still imports 90 percent of its Essential Medicines and
Health Supplies (EMHS). The local production is still nascent
with currently 18 licensed facilities and an additional 12 more
facilities pending licensing. The industry has contributed 230
products to the national drug register against 5,267 products
registered, representing 4.4%. Therefore, regulation of the
pharmaceutical sector, import and export and post marketing
surveillance, are important to ensure that the public is protected
from dangerous medicines.
In Uganda a total of 1010 licensed pharmacists’ practice

in the public and private sector, this gives a ratio of 2.6
pharmacists to 100,000 in the population. The percentage of
public pharmacist positions filled is 56%. The need remains for
district pharmacists to manage, supervise and support medicine
management in lower-level health facilities, FY 2019/20202.
Antimicrobial resistance (AMR) is becoming an increasing

concern worldwide and has been classified as a global threat
against gains achieved by anti-infectives. The contributing
factors to AMR include illegal over-the-counter antibiotic
dispensing especially in drug shops, inappropriate prescription
of antibiotics in un-investigated fevers, and widespread antibiotic
polypharmacy practices especially in the private sector. Uganda
developed the first National Antimicrobial Resistance Strategy
(2017-2022) and surveillance plan for AMR containment that
will continue to be implemented and revised during the HSDPII.
2 ibid
10
2.1.2 The Animal Health sub-sector
The agriculture sector in Uganda to which animal husbandry

is a sub-sector provides food, income and employment to over
80% of Uganda’s population It contributes over 45% of gross
domestic product (GDP) and over 90% of Uganda’s exports.
About 90% of the country’s population is rural and derives
its livelihood from agriculture. For animal husbandry, 58% of
the households depend on livestock for their livelihoods. In
Uganda, there are 14.6 million cattle, 16.9 million goats, 4.6
million sheep, 43.1 million poultry and 4.4 million pigs3. The
increase in human animal interaction continues to increase
the risk and emergency and spread of diseases and poses a
challenge to public health.
3 UBOS, Statistical Abstract 2019.
Veterinary field inspection.
11
A situational analysis on Antimicrobial Resistance

(AMR) in Uganda4 under the auspices of the Global Antibiotic
Resistance Partnership (GARP)-Uganda, showed increasing
trends in antimicrobial resistance to the most commonly-used
antimicrobials (e.g. penicillin, tetracyclines, cotrimoxazole)
which was in some cases above 80 percent. There was
also high prevalence of multi-drug resistant bacteria such as
Methicillin-Resistant Staphylococcus Aureus (MRSA) and
Extended-Spectrum Beta Lactamase (ESBL)-producers. In
healthcare settings, the prevalence of MRSA varied from as low
as 2 percent to as high as 50 percent, while ESBL prevalence
ranged from 10 to 75 percent among isolates analyzed. In
addition, increasing resistance ranging from 4 to 30 percent
was reported among gram negative nterobacteria against
carbapenems, a last-line treatment.
Misuse of antimicrobials in both humans and animals was

well noted with irrational drug use, dispensing over the counter,
in unlicensed drug stores and open markets. Uganda has
put in place an AMR National Action Plan; this plan prioritizes
to integrate and adopt a One Health approach to AMR as a
collaborative, cross-sectoral prevention and control action
between all sectors. Despite all the above threats, there is
limited awareness among the public, policy makers, prescribers
and other professionals about the problem of AMR and its
consequences5, attributed to a number of reasons among which
is poor reporting culture. Resistance to commonly available
acaricides in some parts of the country is an emerging obstacle
to the control of ticks and tick-borne diseases. A national task
force on animal health in the Office of Prime Minister has been
put in place to look at addressing this problem by coming up
with short, middle, and longterm interventions.
4 The Uganda National Academy of Sciences (UNAS)
5 (Source:National Action Plan for AMR, 2017)
12
Sustainable farming can only be achieved if the available

livestock population can equitably generate income, food,
and economic prosperity. Trade in livestock and livestock
products is largely hampered by high prevalence of diseases
including; Foot-and-Mouth Disease (FMD), Contagious Bovine
Pleuropneumonia, Tick-Borne Diseases, TB, Peste des Petits
Ruminitis, Lumpy Skin Disease, Rabies, Brucellosis, African
Swine Fever and Newcastle Disease, among others. Falsified
veterinary products in the market also still present a challenge
to the veterinary subsector, which not only affects the health
and well-being of animals, but also that of humans.
The 1995 Constitution and the Local Government Act of

1997 concentrated delivery of veterinary services to the private
sector (private veterinary practitioners, drug companies, NGOs,
para-veterinarians and feed manufacturing companies). This
has since led to reduction in the public extension system to an
estimated 22% letting the private sector take dominance. So
while, the MAAIF is responsible for improving livestock health,
production and marketing, the existing working institutional
collaboration of the ministry with, local governments,
professional bodies, and academia on regulation of veterinary
drugs has to be strengthened.
The ratio of extension staff to farmers is still low estimated

at over 1:5,000 compared to the recommended ratio of 1:500.
Lack of a country wide animal disease testing/diagnosis
facilities, to effectively facilitate the diagnosis and prescription
of vet drugs. All the above noted developments and gaps
ends up impacting on the rational use of vet pharmaceutical
products.
13
2.2 Performance of the NDA Strategic Plan 2015/16 -

2019/20 Evaluation
The NDA’s overall performance evaluation aligns with the

Strategic Plan 2016-2021 strategic objectives. Performance
data was obtained through a review of the mid-term evaluation
report, annual work plans, group discussions with the staff from
the directorates and external stakeholders. Highlights of the
key achievements are presented under the respective strategic
priority areas below.
2.2.1 Strategic priority: Safety, Efficacy and Quality:
Under this strategic priority a number of achievements were

registered that included;
1. Promotion of domestic production of human and veterinary
medicines and health care products, where a national GMP
roadmap for fifteen manufacturing facilities was rolled out.
In 2019/20 a total of 27 local manufacturers were inspected
for compliance with GMP against the annual target of 20.
2. Systems for spontaneous and active ADR reporting for both
human and veterinary products have been strengthened as
evidenced in the increased number of ADR reports received.
NDA reported an increase in the number of ADR reports
submitted illustrated below.
Year 2015/16 2017/18 2018/19 2019/20
ADR reports
192 439 538 1,824
submitted
14
The increase in the number of ADR reports is attributed to

the increase in regular feedback, improving more reporting
channels, support supervisions, and rollout of market
authorization guidelines for Pharmacovigilance.
3. NDA has further improved its appreciation and use of ICT,
as evidenced where the majority of reports were submitted
through scanned paper forms via mail (48%), 14.4 %
through an e-reporting platform, 1.7% via the Med safety
mobile app and 3.9% via WhatsApp.
4. Systems for product evaluations and premarket authorization
have been strengthened with a noted increase in the number
of dossier evaluations carried out (1912) in 2018/19 to a
total of 1,788 dossiers (1404 human, herbal 225 and 159
Vet) in 2019/20. The average time taken to assess dossiers
has also substantially reduced by about 6 months to 18
months.
5. In 2019/20, 151 clinical trial applications were evaluated
against a set annual target of 160. 90% (137) were evaluated
within the set service delivery timelines as compared to 161
in 2018/19 where 81% (131/161), were evaluated in time.
It was also noted that 12 GCP sites were inspected and
4 new guidelines developed; 3 of which were shared for
stakeholder input in March 2019.
6. NDA has ensured high quality products on the market
through testing of samples. and has continued to tested
more products from 1,321 to 1872.
Year 2017/18 2018/19 2019/20
Samples tested 1,321 1,893 1,872
15
7. There is also an increase in the trend of local herbal products

notification over the last five years.
Year 2015/16 2016/17 2017/18 2018/19 2019/20
Notified 6 12 63 107 152
8. The percentage of pharmaceutical products failing NDA

quality tests decreased to 4.3% (81 out of 1893), down from
13% (176 out of 1321) in 2017/18. There is an increase in
the quality of pharmaceutical products from 87% to 95.7%,
this is attributed to routine monitoring of special products
and introduction of mandatory testing.
9. NDA increased compliance to drug regulations through
extensive implementation of guidelines on good
pharmaceutical practices and good distribution practices.
In 2018/19 a total of 15,413 drug shops against a target of
12,302 and 2016 pharmacy against 2023 compliance visits
were conducted. In 2019/20 a total of 19,087 drug shops
against a target of 12,302 and 1,873 pharmacies against
2023 compliance visits were conducted and increase in
performance of 20% in compliance visits, (from 17,429 to
20,960).
10.NDA maintained a functional laboratory quality system and
acquired ISO 17025 accreditation for the medical device
unit and WHO prequalification re-audit. The NDQCL also
widened the scope of medicines testing to encompass
RDT, SUTURES, hand sanitizers, and herbal medicine on
the Ugandan market.
16
2.2.2 Strategic Priority: Collaboration and Partnership
1. NDA has made effort in improving public confidence on

product safety, efficacy and quality, where a number of
stakeholder engagements/meetings to increase the visibility
of NDA have been conducted, However, more effort in
public awareness and education is still needed in respect of
stakeholder engagement and increasing visibility.
2. NDA established several collaborations at local, regional
and international levels. An MoU with URA to provide a
framework for cooperation in areas of trade facilitation,
sharing of information to restrict unauthorized drugs
imports and exports was signed. Collaborations with
UNCST, UNHRO, NCRI, Mbarara University of Science and
Technology Pharm-Biotechnology and Traditional Medicine
Centre, Gulu University were initiated, including support
to establishment of a Veterinary drugs desk at Makerere
University COVAB.
3. On the regional level, NDA has reviewed regulatory guidelines
for compliance with international standards and partaken to
harmonization of EAC and other collaborative initiatives.
2.2.3 Strategic Priority: Institutional Capacity
1. Through the deployment of NDAMIS, NDA has integrated

and automated nine out of ten business processes. These
processes include: Import and Export verification; GMP;
Inspection; Finance; Product registration and; Navision
integration.
2. NDA has established service delivery timelines (SDT); Key
Performance Indicators (KPI) framework for all regulatory
areas of: Clinical Trials Oversight; Veterinary Trials Oversight;
17
Marketing Authorization; Regulatory Inspection; Premise

Licensing; Market Surveillance and Control; Vigilance;
Laboratory Testing and; National Regulatory System.
3. Construction of the NDA laboratory tower has been initiated
under the past strategic plan period. The construction of a
10-floor microbiology lab structure is underway.
4. NDA achieved Quality Management Systems compliance
to ISO and other international standards, the authority
was issued with the ISO/IEC 9001:2018 Certificate.
The certification scope includes: Registration of drugs;
Pharmacovigilance; Control of clinical and field trials; Control
of publications and advertisement and; Post-Marketing
Surveillance.
Clinical trial field inspection.

18
5. As at June 2020, of the 325 approved posts 288 (89%) are

filled while 37 were vacant as indicated in the table below.
Appr No. No. %

Post No. Filled Vacant Filled
Office for the
Secretary to the 29 26 3 90%
Authority
Directorate
72 64 8 89%
Corporate Services
Directorate
Inspectorate & 121 108 13 89%
Enforcement
Directorate of
25 25 0 100%
Product Safety
Directorate Product
Assessment & 31 30 1 97%
Registration
Directorate
47 35 12 74%
Laboratory Services
Grand Total 325 288 37 89%
There was noted inadequate HR deployment with respect

to the function of research and risk management unit as
currently provided in the structure. Putting in place an
expert’s database on call for technical consultations on
clinical trials technical matters, would further strengthen and
facilitate the implementation of a pro-active ethical research
agenda at NDA.
19
6. Over the strategic planning period, NDA set to out to

strengthen the M&E function by recruiting a Principal M&E
officer and a respective structure of M&E coordinators.
An M&E plan was developed to guide the institution in
developing roles, processes and guideline for conducting the
M&E function. Quarterly, semi-annual, annual and midterm
performance evaluations to track the implementation of the
previous strategic plan were conducted over the period.
In the third year of the strategic plan observed effort was
made to set up a functional M&E performance tracking
database that the monitors progress towards implementing
the strategic plan through its annual work plans.
2.2.4 NDA Financial Performance review 2016-2019
NDA continued to register notable performance

improvement in the strategic plan implementation period
2015 - 2019; Annual Revenue increased by 28% in 2016, 9%
in 2017, 11% in 2018 and then Declined by 4% in 2019 due
to Exchange loss recorded, Annual Expenditure increased by
27% in 2016, 12% in 2017, 9% in 2018 and 10% in 2019.Over
all NDA recorded stable increase in Net Surplus over the years.
No deficit was recorded. NDA recorded a continuous growth in
Assets by 27% in 2016, 21% in 2017, 15% in 2018 and then
27% in 2019. The Accumulated Reserves increased by 25%
in 2016 and 8% in 2019. The increase in revenue was due
to stable macroeconomic factors. The financial indicators are
shown in the table below;
20
FINANCIAL PERFORMANCE REVIEW 2016- 2019 (UGX’000)
Year 2015/16 2016/17 2017/18 2018/19 2019/20
Annual Rev-
enue - Inter- 30,023,159 41,365,605 47,071,811 52,191,016 57,903,411
nal Generat-
ed Funds
Annual Rev-
enue - GOU 392,294 683,851 564,051 436,337 453,763
and donor
Funds
Annual Rev-
enue- Inter- 2,869,521 4,267,481 3,207,835 4,499,620 (3,363,505)
est & Gains
Total Annual 33,284,974 46,316,937 50,843,697 57,126,973 54,993,669

Revenue
Projected
Revenue 28.1 8.9 (3.9)
Growth/De- 11.0
cline
Projected In-
ternal Gen-
erated Fund 27.4 9.8 9.9
Growth/ 12.1
Decline
Annual
Operating 24,002,633 29,882,833 29,893,939 41,719,791 51,879,577
Expenditure
Net surplus 9,282,341 16,434,104 20,949,758 15,407,182 3,114,092
Project-
ed Annual
Expenditure 19.7 0.0 28.3 19.6
Growth/De-
cline
21
FINANCIAL PERFORMANCE REVIEW 2016- 2019 (UGX’000)
Year 2015/16 2016/17 2017/18 2018/19 2019/20
Annual Total
Assets 55,436,764 75,867,036 95,693,536 112,804,368 155,419,868
Annual Ac-
cumulated 51,125,535 68,476,293 89,824,454 104,903,612 114,018,189
Fund
Projected
Asset 26.9
Growth/De- 20.7 15.2 27.4
cline
Projected
Accumu-
lated fund 8.0
Growth/De- 25.3 23.8 14.4
cline
70,000
60,000
50,000
40,000
Planned Budge
30,000
Total Annual R
20,000
10,000
-
Baseline 2015/16 2016/17 2017/18 2018/19
2014/15
Planned Budgeted Revenue

Total Annual Revenue Recorded
22
NDA’s Financial Performance 2014/15- 2018/19

2.3 Stakeholder Analysis, Expectations and Aspirations
To establish the expectations of stakeholders,

consultations were conducted with different groups through
focused group discussions as well as individual consultations.
The NDA stakeholders have been broadly categorized with their
respective roles and responsibilities are highlighted as follows:
Stakeholder Roles and responsibilities
(a) Policy level • Passing policies and laws.

stakeholder namely • Advocacy for Vet and health actions.
MOH and MAAIF; • Performance monitoring.
(b) National regulatory • Oversight, regulation and management

agencies within and of players within and outside the health
outside the health sector to complement regulatory action
sector; of NDA.
• Bench marking of actions.
(c) Medical and Vet • Oversight, regulation and management

practice professional of health and Vet practitioners to
bodies. complement regulatory actions that
enhance compliance.
(d) International and • Bench marking of actions.

regional bodies with • Complement regulatory actions of NDA
whom NDA works • Provision of demand driven
to achieve shared technical assistance and inputs into
goals. implementation of NDA’s focus area.
23
Stakeholder Roles and responsibilities
(e) Supply chain players • Provision of quality drugs and health

products on the market that are
safe, and efficacious. (importers,
manufacturers, wholesalers,
distributors, retail outlets, medical
facilities, health marketing agencies,
traditional medicine promoters).
(f) Civil society • Resource mobilization.

and patient • Providing or participating in research,
organizations. community and social mobilization,
advocacy, capacity building including
human resources development,
logistical support, technical assistance
to complement regulatory actions that
enhance compliance.
• Ensuring proper utilization of resources
and accountability.
(g) Academia • Providing or participating in research,

and research advocacy, capacity building including
organizations. human resources development and
technical assistance.
(h) The media • Complement regulatory action and

visibility of NDA through publicity.
• Reporting on public health.
(i) The general public. • Take care of their health, and practice
appropriate behaviors aimed at seeking
quality, safe, and efficacious drugs and
health products.
24
The focus under stakeholder analysis was to assess

how NDA services, stakeholder relationships, and image,
compound to inform client expectations and the extent to
which these expectations were being met. Major observations
and expectations are highlighted in 2.4.1 to 2.4.8.
2.3.1 Policy, Legal and Regulatory Issues and Concerns
Advocate for review in the law to cover the new scope of

regulated products delegated to NDA that include facemasks,
condoms, blood and blood components, medical devices and
surgical equipment, which are not covered under the current
law.
2.3.2 Collaboration and Partnership Issues
1. Continue with regulatory collaboration and harmonization

efforts within EAC, WHO and other international partners
that are expected to improve the quality of medicines
circulating in the country.
2. There is a need for coordination action among NDA, UNBS,
MOH, MAAIF, human and animal health professional bodies,
UCC, and any agencies whose mandates have a stake in
enforcing, rationalize and harmonize regulatory compliance,
so as to;
a) Increase in medicines user awareness and community
feedback,
b)
Improvement of reporting channels, support
supervisions, and rollout of market authorization
guidelines for Pharmacovigilance.
25
c) Strengthen coordination and partnership actions to

influence positive interventions by stakeholders over
seeing supervision of human and veterinary practices,
d) Strengthen collaboration with relevant stakeholder
to promote rational drug use among farmers who
possess inadequate knowledge in the area strengthen
coordination and partnership actions to influence
positive interventions by stakeholder overseeing the
establishment of necessary infrastructure for GDP and
GPP.
2.3.3 Local Production of Human and Veterinary Medicines
Local manufacturers continue to meet challenges

in complying with GMPs. NDA should continue with its
interventions to provide key technical support and supportive
policy to foster growth of drug manufacturing in the country.
2.3.4 Herbal and Traditional Medicine Issues and Concerns
NDA recognizes and has put in place efforts to regulate

traditional and complementary medicines (TCMs) and put in
a framework for regulation of TCMs. Guidelines on clinical
research on herbal products have been developed to establish
a special collaboration with NCRI in testing and research for
domestic herbal medicines manufacturers. System to regulate
products which includes notification of products, inspection of
premises and approval of adverts for the notified products are
in place.
26
Herbal stakeholder engagement.
While much has been put in place to institute

collaborations with various stakeholders in the area of herbal,
communication and engagement gaps continue to exist that
need to be strengthened. Regulatory challenges also continue
to manifest with advertisements in print and radio media from
TCM practitioners who claim to have products to treat all kinds
of conditions.
2.3.5 Drugs Safety, Efficacy and Quality
Distribution of medicines still happens in buses, pickups,

open-roofed vehicles and in conditions that are not appropriate.
This calls for strengthening the enforcement and monitoring of
compliance to GDP.
27
Assessment of physical condition of medicine stores

in all public and PNFP health facilities revealed that 15% of
the health facilities lacked medicine stores, and 29% did not
have an appropriate designated dispensing room. Strategies
for affirmative regulatory actions in this respect need to be
established.
Coordination and partnership strategic actions need to

be strengthened, to influence veterinary practice and building
capacity of service providers to use and account for the
medicines rationally, given the limited awareness among the
public, policy makers, prescribers and other professionals
about the problem and its consequences6.
Inspection of drug outlets.
6 Source:National Action Plan for AMR, 2017
28
2.3.6 Importation and Exportation of Medicines

NDA has put in place system to regulate products imports,
including evaluation of applications dossiers among others that
continue to ensure safe, efficacious and quality drugs on the
market. However, some gaps in import verification may present
situations that allow for incidences of pilferages, where such
imported drugs are categorized wrongly by the tax authority,
given the limited competence in the area of drugs. The cargo
manifesto provides for prior information on the cargo to ably
establish and isolate category, quantity, origin, classification,
destination and value of the drugs. There is need to enhance
this sharing of prior information between NDA and URA, such
that the former can advise on categorization to avoid pilferage
of drugs on the market as non-drug products.
2.3.7 Corporate Relations, Stakeholder Engagement and

Communication
The public continues to exhibit a knowledge and
information gap on the mandate and roles of NDA for the
regulation of both human and animal drugs, with 49% of
stakeholder that perceive NDA as playing their relevant role.
There is need for continuous stakeholder engagement and
awareness to enhance stakeholder support to NDA in executing
its mandate.
2.3.8 Institutional Development Issues

NDA has progressively rolled out the National Drug
Authority Management Information System (NDAMIS) to enable
the automation of most work processes and procedures, where
up to 9 business processes are currently automated. However,
the business requirements continue to call for improving on the
robustness of the ICT platform to facilitate access to services
and online information and improve on service delivery timelines
(SDTs).
29
2.4 SWOT Analysis
The current situation at National Drug Authority is

characterized by the following strength, weaknesses,
opportunities and threats;
2.4.1 Strengths
How to harness Finding

Key Strategic Issues
to move NDA to greater
Identified
heights
Strategies for policy

Agile government commitment
engagement to ensure
to promote BUBU in
1 responsive policy actions
general and local medicines
in favour of local medicine
manufacturing in particular.
manufacturing.
Existence of an institutional
mandate enshrined in the Advocacy strategy should
National Drug Policy and include actions to engage
3 Authority (NDP/A) Act, Cap. key stakeholders to seek
206 (currently under revision), consensus on necessary
regulations, guidelines and revisions
SOPs.
Existence of a growing
institutional arrangement Institutional development,
(with regional offices) and include deliberate actions for
4
committed leadership to regular institutional reviews and
perform the regulatory human capital development.
function.
Existence of a staff
Establish agenda for medicines
complement in the legal
regulation research to
department to manage on-
5 understand implications of
going and up-coming legal
emerging regulatory issues in
framework review, advice and
the economy
litigation issues.
30
How to harness Finding

to move NDA to greater
Identified
heights
Financial strategy to include

Secure funding as the law
accountability actions to
6 empowers NDA to collect
provide assurance of value for
revenue and spend at source.
money.
Existence of well-equipped
WHO-prequalified laboratories Strategy to cascade quality
7 that have gained rating control laboratory capacity to
in Africa as a centre of regional offices.
excellence.
High-value investment in core Sustainable investment

assets; laboratory equipment in infrastructure to build
8
and NDA- owned land and institutional and regulatory
buildings. capacity.
A Competent, knowledgeable
and experienced staff Review of manpower plan
complement able to match and staff development needs
9
the growing human capacity periodically to align with
requirements of the Authority’s regulatory needs of the time.
mandate.
Opportunity to commercialize
Reference center on medicine
10 the reference services for
regulatory matters.
institutional sustainability.
Further investment in IT to
Developed E-system- automate most of the inter-
11 communication infrastructure, departmental processes and
NDAMIS GMP module. on-line access to regulatory
services.
Expanded organizational Inclusion of regular rational

structure (Regional offices) organization reviews and work
12
to assert its regulatory pulse load audits in the institutional
throughout the country. development strategy.
31
2.4.2 Weaknesses
How the findings could be

addressed to move NDA
Identified
to greater heights
Absence of whistle blower Policy should be finalized and

1
policy. adopted by NDA.
Automation of business
Include investment in
processes not fully developed
automation of process as
to support key real time.
a priority in institutional
2 performance and decision
development.
making, information sharing,
regulatory services access
activities.
Public misconception of Strategies to foster

roles of other linkage MDAs coordination/engagement,
in the health sector service communication, information
3
delivery chain as those of sharing and public education
NDA, negatively impacting its actions on these cross-cutting
reputation. issues.
Further investment in IT to
Absence of a national geo- automate most of the inter-
4 mapped drug shops/mapping departmental processes and
of drug shops or pharmacies. on-line access to regulatory
services.
Consider development of a
holistic communication and
Limited public visibility of NDA engagement strategy.
5 occasioned by low public Enhance significance of
stakeholder engagement. Information, engagement
and communication in the
institutional structure.
32

addressed to move NDA
Identified
to greater heights
Consider periodical staff

Limited staffing leading to
audits and phased increase in
6 limited presence beyond the
numbers and deliberate human
headquarters.
capital development.
Periodical institutional capacity

Insufficient infrastructure review and appropriate
7 relative to the scope and additional investment in
nature of operations. systems and equipment to
match regulatory needs.
Cumbersome drugs
Investment in automation of
inspection and enforcement
processes to improve efficiency
8 protocols causing regulatory
of both documentation and
delays and inconveniences to
physical routines.
regulatory customers.
Reliance on district drug Work analysis strategies to

9 inspectors who are not NDA align human resource capacity
employees. work responsibilities.
33
2.4.3 Opportunities

harnessed to move NDA
Identified
to greater heights
Receptive public, public Consider a whistleblower

support through increased incentive strategy to enhance
1 reporting of unscrupulous the effectiveness of this
operators in the reporting modality.
pharmaceutical sector.
GOU investment in the Institutional development

national IT backbone and strategy to include investment
adoption of e-government in IT and systems integration
present opportunities for with common user data bases
2 NDA to harness IT to cost- and platforms i.e. NMS ERP.
effectively undertake its
country-wide medicines
regulatory functions in
coordination with other MDAs.
The Corvid-19 pandemic Institutional development

ramifications have raised the strategy should include
significance of investment in capacity up-grades (of tools,
3 the Health Sector in general processes, HR) to engage in
and medicines regulation emerging collaborative actions
processes and best practices relevant to its functions.
in particular.
Supportive regional and Institutional capacity

international collaborative enhancement strategy should
4 mechanisms. focus on domestication of
mechanisms to achieve
efficiency.
Advent of the “One Health” The collaboration strategy

strategy to promote multi- should include modalities for
sectoral and interdisciplinary tapping into regulatory support
5 application of knowledge and and benefits available from this
skills of medical, public health, initiative.
veterinary and environmental
experts.
34

harnessed to move NDA
Identified
to greater heights
Supportive regional and The collaboration strategy

international collaborative should include actions to
mechanisms with domesticate and tap into
Harmonization Project regulatory synergies arising
collaborative mechanisms from this.
5 with EAC, African Medicines
Regulatory, WHO,
International Organization
for Standardization(ISO),
Pharmaceutical Inspection and
Certification Scheme (PICS).
Emerging MDA Collaborative IT integrated strategy for

practices that are being driven automation of internal
by the search for efficiency to processes and sharing of
6
serve common public good databases among common
through adoption of integrated user databases.
IT platforms.
WHO prequalification Financing/resource

provides an opportunity mobilization strategy should
7
for commercialization for consider actions for adoption
laboratory testing services. of this opportunity.
Development partners interest Institutional development

in increased quality and safety strategy to include hard and
8 of Medicines. soft actions and investments
to enhance capacities for
medicines regulation.
Increased scope of products When enacted, strategies for

to be regulated under the implementing the additional
9 UFDA when enacted from the functions and necessary
current Bill. structures to be considered
then.
Global shift towards self- Policy advocacy strategies

financing mechanisms to to incorporate actions to
10 support regulatory activities. institutionalize the self-
financing concept in NDA’s
regulatory business model.
35
2.4.4 Threats
Key Strategic Issues How the findings could be

Identified harnessed to move NDA to
greater heights
A section of the public with

IEC strategy should include
the perception that relate the
actions to address the
1 pharmaceutical products from
apparent information gap
Asia and locally manufactured
among the public.
to be of inferior quality.
Strategies for coordination

Porous borders that allow the and partnerships with security
2 smuggling of drugs that allow agencies, other regional
inflow of unregulated products. regulatory agencies and
communities to curb the vice.
Strengthening collaborative
Conflicting roles by the
mechanisms with agreed upon
different agencies to promote
MoU.
3 their agenda despite related
Advocacy strategy to include
regulatory scopes that call for
actions to influence necessary
synergistic action.
changes in the legal framework.
Strategies for policy

Policy shifts that lead to loss
engagement to ensure
4 for revenue to NDA (e.g. on
responsive policy actions
development partners).
towards resource mobilization.
Litigation from clients that Stakeholder engagement and

5 threaten image and financial appropriate review of drug
sustainability. regulations.
Insufficient number of health Strategies for corroboration

6 personnel to supervise drug with health professional bodies
outlets. to enhance rational drug use.
Non prohibitive sanctions for Stakeholder engagement and

7
non-regulatory compliance. appropriate review of the law.
36
2.5 Organizational Structural Analysis
It is a management principle that structure follows

strategy. When a new strategy is formulated and subjected to
changes as a result, there arises a need to assess whether the
existing structure is adequate to implement the new strategy or
not. Based on the situational analysis findings that informed the
new strategy and the ramifications that the implementation of
the new strategy will have on the institutional performance the
following functional analysis issues are apparent;
Overall an institutional structure review should follow the

approval of the strategic plan and has been included as one of
the actions to be implemented. This should re-align the current
structure to the new strategic plan implementation capacity
requirements.
2.6 Critical Gaps and Emerging Issues, Recommendations

and Interventions
Issues Identified Strategic

Recommendations
Inadequate reporting of Policy engagement and

1 adverse events by the health stakeholder collaboration with
facilities and consumers. Ministry of Health.
Noncompliance with good Policy engagement for

2 pharmacy practice by public responsive policy actions to
and PNFP health facilities. support compliance with GPP.
Irrational drug use. Establish Collaborative

programmes with health
3 professional bodies to
enhance rational drug use.
37

Recommendations
Increased AMR AMR National Action Plan be

4 implemented on collaborative
basis with relevant MDAs.
Increased demand to test a Enhance the laboratory

5 range of new products. capacity to meet the increased
demand.
Lack of funding in the public Partner with private or public

sector for the removal of logistics entities to retrieve
expired medicines and medical expired and medical wastes.
wastes.
6 Policy advocacy for funding
and long-term Investment
in infrastructure and
operationalization.
Weak institutional capacity to Strengthen NDA Clinical

sanction and regulate clinical research capacity and
7 trials. adopt good clinical research
practices.
Gaps in NDP/A Act, and Engage and advocate for

regulations require legislative enactment of NFDA bill into
8 amendment with respect to law.
regulation of masks, condoms,
sutures, diagnostic kits.
Limited public visibility of NDA Develop a holistic

9 occasioned by low public communication and
stakeholder engagement. engagement strategy.
Inadequate office and Develop the NDA infrastructure

laboratory infrastructure both and facilities for its growth and
10 at region level and head office. enhancement of its regulatory
roles in the sub-sector both at
regional and head office.
38

Recommendations
Low adoption of automation Improve and integrated

of business processes in key management information
decision making, information system across the organisation
11 sharing and regulatory services and other MDAs that have
access regulatory activities related databases.
and inadequate ICT capacity
and automation infrastructure.
Structural and Staffing gaps Review the HR capacity to

12 address expanded scope of
work.
Increased operational cost due Develop and implement

a framework for resource
13 to the expanding regulatory
responsibilities. mobilization to foster
sustainability.
Inadequate automation of Scale up the automation of all

14
business processes. business processes.
2.7 The Significant Unfinished Priorities from Previous

Strategic Plan
A number of undertakings with NDA regulatory implications

were started but not completed and will need to be brought
forward into the current HSDP and aligned with NDA’s strategic
plan running for the same period. These include;
• Legislation and approval of the Bill for establishment of the
National Food and Drug Authority.
• Establishment of the Track and trace system of
pharmaceutical products by NDA.
• Completion and equipping of the NDA Quality Laboratory
tower.
39
3.0 STRATEGIC
DIRECTION
40
This chapter presents the goal, vision, mission, core

values and stated strategic objectives and outcomes as well
as the strategic interventions and actions that NDA intends to
peruse for the next five-year period in fulfilling its mandate.
3.1 Preamble
The strategic direction (vision, mission, core values,

mandate, and functions) of NDA guides all strategy discussions
for the organization. It provides the framework based on
which the planning and operational details for translating the
organization’s statutory functions into real actions that deliver
outputs and ultimately outcomes and results, are crafted.
The vision, mission and core values were reviewed as part

of the organizational assessment and were aligned to NDA’s
new strategic direction.
41
3.2 Rationale for National Drug Authority Strategic Plan

2020-2025
The NDA Strategic Plan has been developed to

address the strategic critical gaps, emerging issues, strategic
recommendations and interventions identified in chapter two
above to meet the stakeholder expectations and aspirations,
and to enhance NDA’s regulatory service delivery for the
medium term. The plan has also been designed to maximize
NDA’s contribution to the attainment of sector, national, and
international development agendas. At the sector level, it has
also been appropriately aligned to the National Pharmaceutical
Sector Strategic Plan and the Health Sector strategic focus.
At the national level, it has been aligned to the NDP III
programmatic planning and budgeting framework to optimize
its contribution to the national development goals and medium-
term objectives of the NDP III and ultimately the Uganda Vision
2040. At the global level, it has been aligned to the Sustainable
Development Goal (SDG) 3: “Ensure healthy lives and promote
well-being for all at all ages.” and WHO policy direction on drugs
regulation.
3.3 Vision
“A world class drug regulatory Agency.”
3.4 Mission
To protect and promote human and animal health through

the effective regulation of drugs and healthcare products.
42
3.5 Core Values
• We Care for the people of Uganda.

• We take Pride in what we do.
• We serve with Integrity.
• We value Team spirit.
• We Embrace new knowledge and Innovation.
3.6 Goal
To attain and maintain global best practices in drug

regulation by 2025.
3.7 Strategic Objectives
The contextual analysis, organizational assessment,

stakeholder expectations, aspirations of the Authority and staff
present a context of efficiency that can only be achieved through
digitization to make it possible to access services and share
information on-line and real-time as much as possible and to
minimize duplication of effort and physical rigour. NDA is also
mindful that it cannot implement its mandated functions in silo.
Rather, it must adopt collaboration and partnership strategies
with other agencies to facilitate the proper implementation
of those borderline activities whose effective outcomes and
outputs have a causal impact on the destiny of NDA’s regulatory
exploits. NDA seeks to leverage opportunities in contributing
towards the existing Strategic Plans (NDP, Ministry of Health
43
Strategic Plan, NVDP, NPSSP and other relevant health sector

players), regional level protocols (EAC medicines harmonization,
IGAD and African Medicines Agency) and international best
practices.
In response to the identified critical gaps and emerging

issues, four Focus Areas and strategic objectives respectively
have been identified to guide the formulation of the interventions
over the next five years:
Focus Area 1: Core Service Delivery:

To attain the highest standards of drug regulatory excellence,
there is a need to enhance the regulatory operational
effectiveness to support the Universal health coverage by
ensuring access to safe, efficacious and quality drugs.
Strategic Objective 1: To improve the Regulatory

efficiency and effectiveness that ensures safe, efficacious
and quality drugs and health products.
This strategic objective will focus on the key actions
that NDA will undertake to sustainably improve efficiency and
effectiveness of the processes and systems to deliver on its
core mandate.
Five key strategies, presented below are proposed to realize

the strategic objective;
1. Strengthen systems and institute regulatory actions that
support local drugs manufacturing.
44
2. Strengthen systems and institute actions that support drug

regulatory compliance by human and vet practitioners.
3. Strengthen the research capacity for making evidence
based drug regulatory decisions.
4. Strengthen the systems, processes and procedures for
pre-market authorization of drugs and healthcare products.
5. Strengthen the systems, processes and procedures for
post-market authorization of drugs and healthcare products.
Focus Area 2: Legal and Regulatory framework:

Strategic Objective 2: To Streamline the legal and
regulatory framework for operational effectiveness of
NDA.
Proper scoping of the regulatory/legal priorities and requisite
actions to add value and improve the drugs and health products
sub sector regulatory environment will be a key focus of this
strategic objective, during the five-year strategic period. The
key strategies will be to;
1. Advocate for an improved regulatory framework.
2. Strengthen the regulatory framework.
Focus Area 3: Stakeholder awareness and engagement

and Collaboration:
This area of focus shall be harnessed through; Public awareness,
collaboration and partnerships with Local government, MDAs,
regional and international organizations to create visibility and
enhance execution of NDA’s mandate.
45
Strategic Objective 3: To increase stakeholder

awareness, engagement and collaboration to support
NDA regulatory functions.
Three key strategies, presented below are proposed to realize
the strategic objective;
1. Strengthen mechanisms for stakeholder awareness and
engagement.
2. Enhance internal corporate and public relations function.
3. Enhance stakeholder collaboration and partnership at
national, regional and international level.
Focus Area 4: Institutional Development:
As a regulator, NDA should at all times ensure that it has
adequate resources for effective regulation of drugs. It should
have in place institutional structures, systems, staffing capacity,
governance and management practices that can enhance her
planning, coordination and regulatory capacities.
Strategic Objective 4: To improve NDA institutional

capacity to effectively and efficiently implement its
functions
Six key strategies, presented below are proposed to realize the

strategic objective;
1. Enhance the NDA infrastructure and facilities for her capacity
growth.
2. Strengthen and ensure a sustainable management
information system through automation and integration
across the organization and other relevant MDAs.
46
3. Strengthen Corporate Governance practices and Human

Resource capacity.
4. Enhance the Institutional resource mobilization capacity
and sustainability.
5. Strengthen the corporate planning and performance
management systems
6. Strengthen the Quality Management Systems across the
organization.
3.8 Strategy Slogan
“Safe drugs Save Lives”
3.9 Linkage of the NDA Strategic Plan to NDP III
The NDA strategic plan contributes to NDP III through 4

programme areas: –
Human capital development:
NDA strategic plan is aligned to objective 4 of

the NDP III Human Capital Development (HCD)
Programme– “Improve population health, safety
and management”. NDA’s strategic plan is aligned
to interventions that improve the functionality of
the health system to deliver quality and affordable
preventive, promotive, curative and palliative health
care services. NDA will implement regulatory systems,
47
processes, and procedures that guarantee availability of safe,

efficacious and quality drugs and health care products used in
Uganda to ensure the health of the Ugandan population.
Agro-industrialization Programme:
NDA strategic plan is aligned to objective 1 of the

NDP III Agro-Industrialization programme – “Increase
production and productivity”. NDA’s interventions
will contribute to agro-industrialization through the
regulation and promotion of local production of agro-
based pharmaceutical raw materials (animal and plant
origin).
Private sector development:
NDA strategic plan is aligned to objective 5 of the

NDP III Private Sector Development Programme
–”Strengthen the enabling environment and
enforcement of standards”. NDA’s interventions
will create an enabling environment for the private
sector through pro-active drug regulations that
support availability of the drugs to the entire population
of Uganda.
Manufacturing:
This NDA strategic plan is aligned to objective 2 of

the NDP III Manufacturing Programme – “Increase value
addition for import substitution and enhanced exports”
and in particular, the intervention that support existing
local manufactures for pharmaceutical products. NDA
will contribute to the support of the Good Manufacturing
48
Practice (GMP) compliance assessment system for local

pharmaceutical manufacturers as well as review and update
standards, regulations and guidelines to cater for indigenous
Pharma remedies.
Drug Laboratory Capacity building.
49
Programme and Focus Area alignment matrix
NDA focus area

NDP III NDP III NDA Focus Strategies to attain
Programme Interventions Area NDP3 programme
Objective objectives interventions and
objectives
NDP III Programme: Human capital development
NDA Focus Area: Core service delivery
Objective 4: 4.3 Improve To improve the • Strengthen systems

To improve pop- the function- regulatory effi- and institute regulatory
ulation health, ality of the ciency and ef- actions that support
safety and health system fectiveness that local drugs manufac-
management. to deliver ensure safe, turing.
quality and • Strengthen systems
affordable efficacious and
and institute actions
preventive, quality drugs that support drug
promotive, and health regulatory compliance
curative and products. by human and vet
palliative practitioners.
health care • Strengthen the
services. research capacity
for making evi-
dence-based drug
regulatory decisions.
• Strengthen the
systems, processes
and procedures for
pre-market authori-
zation of drugs and
healthcare products.
• Strengthen the
systems, processes
and procedures for
post-market autho-
rization of drugs and
50
NDA focus area

objectives
NDP III Programme: Agro-industrialization Programme
Objective 1: 1.3 To improve the • Strengthen systems

Increase Strengthen the regulatory effi- and institute regulato-
production and agricultural ciency and ef- ry actions that support
productivity. inputs markets fectiveness that local drugs manufac-
and distribu- ensure safe, turing
tion systems • Strengthen systems
to adhere to efficacious and
and institute actions
quality quality drugs that support drug
standards and and health regulatory compliance
grades. products. by human and vet
practitioners.
1.9 To improve the • Strengthen systems

Strengthen regulatory effi- and institute actions
systems for ciency and ef- that support drug
management fectiveness that regulatory compliance
of pests, ensure safe, by human and vet
vectors and practitioners.
diseases. efficacious and
• Strengthen the
quality drugs research capacity
and health for making evi-
products. dence-based drug
regulatory decisions.
• Strengthen the
systems, processes
and procedures for
pre-market authori-
zation of drugs and
• Strengthen the
systems, processes
and procedures for
post-market autho-
51
NDA focus area

objectives
NDP III Programme: Private sector development
Objective 5: 5.1. To improve the • Strengthen systems
Strengthen Support the regulatory effi- and institute regulato-
the enabling national ciency and ef- ry actions that support
environment and conformity fectiveness that local drugs manufac-
enforcement of assessment ensure safe, turing.
standards. system to • Strengthen the
attain interna- efficacious and
systems, processes
tional quality drugs and procedures for
recognition and health pre-market authori-
through Ac- products. zation of drugs and
creditation. healthcare products.
• Strengthen the
systems, processes
and procedures for
post-market autho-
NDP III Programme: Manufacturing

Objective 2: 2.1 To improve the • Strengthen systems

Increase value Support regulatory effi- and institute regulato-
addition for im- existing local ciency and ef- ry actions that support
port substitution manufactures fectiveness that local drugs manufac-
and enhanced for both med- ensures safe, turing.
exports. ical products
and efficacious and
Pharmaceuti- quality drugs
cals. and health
products.
52
3.11 Strategic Objectives and Expected Outcomes
Key strategic emerging issues from the situational analysis

have been identified and framed into strategic recommendations
from which strategies and actions have been ultimately developed.
This presents the summary of the objectives, strategies and
outcomes for the 5-year horizon. The detailed M&E framework,
with the expected outputs at activity level is provided as Annex 1.
Table 1: Key Outcome Results Matrix

Baseline
2020/21
2021/22
2022/23
2023/24
2024/25
Goal and
Outcomes Indicator
Objectives
Goal Percent-
To attain Increased age of
and access to regulatory
maintain safe and functions
global best effective meeting
World 13% 13% 13% 13% 13% 100%
practices quality Health
in drug drugs and Organiza-
regulation health tion (WHO)
by 2025. products. Maturity
Level 3.
Objective Improved
1: To im- regulatory
prove the systems,
regulatory processes
efficiency and proce- Proportion
and effec- dures that of SDT’s
tiveness guarantee implement-
that ensure availability ed within 78% 80% 80% 82% 84% 86%
safe, of safe, the agreed
efficacious efficacious timeline.
and quality and quality
drugs and drugs and
health health
products. products.
[contd...]
53
Baseline
2020/21
2021/22
2022/23
2023/24
2024/25
Goal and
Outcomes Indicator
Objectives
Objective
1: To im-
prove the Improved
regulatory public ac- Proportion
efficiency cess and of im-
and effec- utilization proved per-
tiveness of safe, formance 59% 65% 70% 75% 80% 85%
that ensure efficacious in core
safe, and quality service
efficacious drugs and delivery.
and quality health
drugs and products.
health
products.
Objective Proportion
2: To of target
stream- stake- 4
line the holder meet- 80% 85% 85% 85% 85%
legal and engaged in ings
regulatory Harmonized advocacy
frame- legislative initiatives.
work for frame-
operational work that
effective- enables an Proportion
ness of effec- of Regula-
NDA. tive and tions and
well-func- Guidelines 100% 100% 100% 100% 100% 100%
tioning developed
regulatory and pub-
system
for drugs lished.
and health
products.
Transfor-
mation of UNF-
NDP&A DA in
Act into place
UNFDA.
54
Baseline
2020/21
2021/22
2022/23
2023/24
2024/25
Goal and
Outcomes Indicator
Objectives
Increased Proportion
public of the
aware- stakehold- 83% 85% 90% 93% 93% 93%
ness, ers aware
knowledge of NDA
and prac- role.
tices about
Objective safety,
3: To efficacy Proportion
increase and quality of Satisfied 75% 75% 75% 80% 80% 85%
public of drugs, customer.
awareness,
and stake-
holder Increased
collabora- positive
tion to sup- percep-
port NDA tion and Proportion
regulatory visibility of of the
functions. NDA as an stakehold-
effective ers that 49% 59% 69% 79% 89% 95%
global perceives
standard NDA as
regulator playing her
within the role.
health
system.
Objective Improved
4: To im- institu-
prove NDA tional in-
institution- frastructure % of
al capacity to enable planned in-
to effec- effective stitutional
tively and regulatory infrastruc- TBD 60% 70% 75% 80% 80%
efficiently service ture imple-
imple- deliv- mented.
ment its ery and
functions specialized
[contd...] operations.
55
Baseline
2020/21
2021/22
2022/23
2023/24
2024/25
Goal and
Outcomes Indicator
Objectives
Proportion
of insti-
tutional
business 0% 0% 31% 63% 94% 100%
processes
fully auto-
Enhanced mated.
digital
transfor-
mation for
regulatory Percentage
effective- of online
ness. services
accessed
throughout 99% 99% 99% 99% 99% 99%
Objective the year
4: To im- (Uptime
prove NDA of online
institution- services).
al capacity
to effec-
tively and Increased proportion
efficiently human of staff
implement resource who attain
its func- produc- 65% of
tions. tivity to approved 100% 95% 100% 100% 100% 100%
deliver perfor-
the NDA’s mance
regulatory targets.
mandate.
% in-
crease in 63,2 +5% +5% +5% +5% +5%
Improved generated bn
financial revenue.
sustain-
ability of
NDA.
Working 82% 90% 90% 90% 90% 90%
ratio.
56
Table 2: Key Strategic Actions
Strategic
Strategic Actions
interventions
Strategic Objective 1: To improve the regulatory efficiency and

effectiveness that ensure safe, efficacious and quality drugs and
health products.
1.1: Strengthen 1.1.1: Strengthen mechanism

systems and institute to support actions for local drug
regulatory actions that manufacturing.
support local drugs
manufacturing.
1.2.1: Strengthen collaborative

programmes with vet professional
bodies, MDA, local government,
and vet practitioners to ensure
safety, efficacy and quality and
1.2: Strengthen enhance rational vet drug use.
systems and institute
1.2.2: Strengthen collaborative
actions that support
programmes with human health
drug regulatory
professional bodies, MDA, private
compliance by human
clinical practitioners to ensure
and vet practitioners.
safety, efficacy and quality and
enhance rational human drug use.
1.2.3: Strengthen mechanisms
that support compliance with GDP,
GPP, GVP, and GCP.
1.3: Strengthen the 1.3.1 Establish mechanisms to

research capacity for support evidence-based drug
making evidence- regulatory research and decision
based drug regulatory making.
decisions.
57
Strategic
Strategic Actions
interventions
1.4: Strengthen the 1.4.1. Strengthen mechanism for

systems, processes regulation of product assessment
and procedures and evaluation, authorization and
for pre-market conduct of clinical and field trials for
authorization of drugs and health care products.
drugs and healthcare
products.
1.5.1 Improve systems for effective
control of imports and exports.
1.5.2: Enhance systems for PMS.
1.5.3. Strengthen systems,

processes and procedures for testing
1.5: Strengthen the drugs and health care products.
systems, processes
and procedures 1.5.4: Strengthen system, process
for post-market and procedures for enforcement of
authorization of laws and regulations.
drugs and healthcare
products. 1.5.5: Enhance coordination and
partnership schemes with relevant
agencies for improved drug
surveillance.
1.5.6. Strengthen system, processes

and procedures for regulation of drug
advertisements.
Strategic Objective 2: To streamline the legal and regulatory

framework for operational effectiveness of NDA.
2.1: Advocate for an 2.1.1: Advocacy strategy to include

improved regulatory actions to influence necessary
framework. changes in the legal framework.
2.2: Strengthen the 2.2.1: Strengthen regulatory

regulatory framework. requirements.
58
Strategic
Strategic Actions
interventions
Strategic Objective 3: To increase public awareness, and

stakeholder collaboration to support NDA regulatory functions.
3.1.1: Enhance stakeholder

3.1: Strengthen awareness and engagement.
mechanisms for
stakeholder awareness 3.1.2: Enhance drug regulatory IEC
and engagement. program target sharing information
with public on topic issues.
3.2: Enhance internal 3.2.1 Strengthen internal

corporate and public communication capacity to project a
relations function. strong corporate image.
3.3: Enhance 3.3.1: Strengthen the partnership

stakeholder strategy to harness synergies and
collaboration and best practices in drug regulation.
partnership at
national, regional and
international level.
Strategic Objective 4: To strengthen NDA institutional capacity

to effectively and efficiently implement its functions, (infrastructure,
performance systems, human resource, finance).
4.1.1: Completion and Equipping

of the laboratory tower and
4.1: Enhance the microbiology lab (Mulago).
NDA infrastructure
4.1.2: Construction of the NDA Office
and facilities for her
Tower.
capacity growth.
4.1.3: Establishment/ construction of
regional offices.
59
Strategic
Strategic Actions
interventions
4.2: Strengthen and 4.2.1: automate and integrated all

ensure a sustainable business processes at NDA including
management track and trace system.
information system
through automation 4.2.2: Secure ICT infrastructure
and integration across across the organization.
the organization and
other relevant MDAs.
4.3.1 Harness the Drug Authority

oversight and operation.
4.3.2: Enhance institutional

development through regular reviews
and human capital development in
4.3: Strengthen line with human rights.
Corporate Governance
practices and Human 4.3.3: Enhance an effective
Resource capacity. administration system.
4.3.4: Strengthen internal Audit

oversight.
4.3.5: Establish mechanisms for

timely service delivery.
4.4.1 Strengthen mechanisms

4.4: Enhance the for resource mobilization and
Institutional resource sustainability.
mobilization capacity
and sustainability. 4.4.2: Promote regulatory self-
financing.
4.5: Strengthen the 4.5.1 Strengthen planning.

corporate planning
4.5.2 Strengthen risk management
and programme
system.
performance
management systems. 4.5.3 Strengthen M&E system.
60
Strategic
Strategic Actions
interventions
4.6: Strengthen the 4.6.1 Strengthen the Quality

Quality Management Management Systems.
Systems across the
organization.
61
4.0 FINANCING OF THE

PLAN
62
This section presents the framework for financing the plan

to ensure the implementation of the set plans and achievement
of targeted outcomes for the period 2020/21-2024/25. The
section indicates the overall and disaggregated costs of the
plan, and the strategies for mobilizing the required financing.
4.1 Costing and Financing Framework
Financing for the Plan is expected to increase over

the NDPIII period. Notably, given the central role of NDA in
addressing key NDPIII strategies, we expect its financing to
increase. Overall, we expect NDA’s financing for development
of the required infrastructure, IT and equipment to increase as
well as financing towards ensuring Completion and Equipping
of the microbiology lab at National Drug Quality Control Lab
(NDQCL) and NDA Tower.
63
4.1.1 The Strategic Plan Budget — 2020/21- 2024/25
Overall, a total of UGX, 485.3.Bn is required to implement

the strategic priorities of NDA for the five years. The detailed
breakdown is given in table below.
4.1.2 Projected Expenditure
The table below shows the indicative expenditure

projections over the five-year period, with an annual projected
expenditure growth of 5%.
64
Table 2: Projections for 2020/21 – 2024/25 (Ugx in Billions)
Strategic
FY 2020/21 FY 2021/22 FY 2022/23 FY 2023/24 FY 2024/25 Total
Actions
Sub-total: Stra-
tegic Objective
1:
To improve
the regulatory
efficiency and 14,354,446,422 14,269,639,021 13,595,551,801 14,196,132,437 14,228,775,085 70,644,544,766
effectiveness
that ensure safe,
efficacious and
quality drugs and
health products.
Sub-total: Strate-
gic Objective 2:
To rationalize the
legal and regula-
tory framework 701,184,000 794,334,000 810,220,680 826,425,094 842,953,595 3,975,117,369
for operational
effectiveness of
NDA.
65
66
Strategic
FY 2020/21 FY 2021/22 FY 2022/23 FY 2023/24 FY 2024/25 Total
Actions
Sub-total: Strate-
gic Objective 3;
To increase pub-
lic awareness,
and stakeholder 1,971,550,000 2,211,696,800 2,255,930,736 2,451,049,351 2,500,070,338 11,390,297,224
collaboration
to support NDA
regulatory.
Sub-total: Stra-
tegic Objective 4:
To improve
NDA institu-
tional capacity 12,973,819,578 16,198,330,179 16,812,296,783 16,000,393,120 15,944,798,453 77,929,638,113
to effectively
and efficiently
implement its
functions.
NON-WAGE 30,001,000,000 33,474,000,000 33,474,000,000 33,474,000,000 33,516,597,471 163,939,597,472

SUMMARISED BUDGET
WAGE 34,461,275,637 36,727,391,277 38,784,125,188 40,956,036,199 43,249,574,226 194,178,402,528
NON-WAGE 30,001,000,000 33,474,000,000 33,474,000,000 33,474,000,000 33,516,597,471 163,939,597,472
TOTAL
64,462,275,637 70,201,391,277 72,258,125,188 74,430,036,199 76,766,171,697 358,118,000,000
RECCURENT
DEVELOPMENT 19,371,000,000 34,309,000,000 25,358,000,000 25,358,000,000 22,808,000,000 127,204,000,000
TOTAL 83,833,275,637 104,510,391,278 97,616,125,188 99,788,036,200 99,574,171,698 485,322,000,000
67
4.1.3 Projected Revenue
The table below shows the projected funding requirement

to finance the strategy over the five-year period, with a Projected
Revenue growth at 15%.
Table 3: Projections for 2020/21 – 2024/25 (UGX Billions)
2022/23
2023/24
2024/25
2020/21
2021/22
Revenues
Total
FY
FY
FY
FY
FY
NDA Internal
Revenue
Manufacturers’
9 9 9 10 10 48
Inspection fees
Manufacturers’
11 12 13 13 14 63
Suitability fees
Manufacturers’
12 11 12 12 13 60
License fees
Pharmacies Renewal
613 625 656 689 724 3,307
- Suitability fees
Pharmacies Renewal
563 573 602 632 663 3,032
- License fees
New Pharmacies -
69 77 81 85 89 401
Suitability fees (new)
New Pharmacies -
19 21 22 23 24 110
License fees (new)
Renewal of Drug
shops - Suitability 673 597 627 658 691 3,246
fees
Renewal of Drug
686 686 720 756 794 3,643
Shops - License fees
New Drug Shops -
162 178 187 196 206 929
Suitability fees
68
2022/23
2023/24
2024/25
2020/21
2021/22
Revenues
Total
FY
FY
FY
FY
FY
New Drug Shops -
108 119 125 131 138 621
License fees
Verification fees 42,783 48,773 51,212 53,772 56,461 253,001
Drug Registration
2,927 2,478 2,602 2,732 2,869 13,607
fees
Drug Retention fees 8,142 6,923 7,269 7,633 8,014 37,981
Amendment Fees 1,541 1,463 1,536 1,613 1,694 7,847
cGMP Audits 6,939 6,201 6,511 6,837 7,178 33,666

National Quality Control
200 323 339 356 374 1,593
Lab Analysis Fees
Rent - Plot 59
187 187 196 206 216 993
Nkrumah road
Others - Clinical
864 876 920 966 1,014 4,640
Trials
Total Internal
66,509 70,132 73,639 77,321 81,187 368,787
Revenue
GOU 0.0 0 0 0 0 0
Internal Revenue
18,441 34,309 2,000 2,000 0 56,750
Reserves
Total Revenue 84,950 104,441 75,639 79,321 81,187 425,537
Funding Gap 931 22,715 23,358 23,358 22,808 93,171
Percentage
69
Funding Gap
2020/21
2021/22
2022/23
2023/24
2024/25
Item
FY
FY
FY
FY
FY
Total
Total exp. 83,833 104,510 97,616 99,788 99,574 485,322
Total Revenue 84,950 104,441 75,639 79,321 81,187 425,537
Funding gap 0 -69 -21,977 -20,467 -18,387 -60,900
Percentage 0.1% 23% 21% 18% 12%
Over the planning period, the NDA plan has a funding gap
of 59.785 billion. NDA has come up with deliberate initiatives to in
respect of covering this funding gap that include recruiting resource
mobilization officer under the office of the SA and undertaking
activities in the strategic plan related to resource mobilization.
4.1.4 Projected Financial Sustainability
Over the planning period, NDA will undertake action on both

fronts to generate sufficient revenue, as well as manage expenditures.
The revenue base shall be broadened from the delivery of its core
services but also from other sources to ensure that NDA is better able
to achieve its objectives over the five-year period. Equally rational and
effective controlling systems will be further strengthened to detect
and eliminate deviations from accepted financial plans, manage
cost pressures better and improve performance and contribute to
attainment of national development priorities in Uganda’s Vision
2040 and National Development Plan III.
70
4.2 The Major Cost Drivers Over the Planning Period
The cost drivers of financial expenditures during the medium

term will be the strategic objectives to be realized during the period.
These shall include the following: operational costs such as salaries,
utilities and property expenses, medicines and supplies and supplies
and services, maintenance.
4.3 Key Financial Assumptions
1. Budget will be financed by Internally Generated Funds.

2. Projected Revenue growth will be at 15% and Projected Growth
in the wage bill of 5.6% and non-wage of 2%.
3. NFDA Bill in place leading to additional revenue.
4. NDA to use Capital reserves, Recurrent surplus and
domestic arrears to fund Capital Expenditures.
5. Revenues are projected to growth by 15% Annually.
71
5.0 IMPLEMANTATION
ARRANGEMENTS
72
This chapter presents the overall arrangements for

implementing the setout actions in the strategic plan as well as
the delegated roles by the different parties.
5.1 Institutional arrangements for Plan implementation

5.1.1 Objectives
Implementation of this Strategic Plan calls for the clear

allocation of roles and responsibilities for implementing all
planned activities, with reporting lines running hierarchically to
the structure of NDA.
Information sharing and formation of task and cross-

functional teams shall also be necessary in the implementation of
cross-cutting activities involving public relations and stakeholder
collaborations, with government relevant Public Sector
Institutions: (MoH, MAAIF UNBS): health and vet practitioners
73
public and private, relevant Vet and Health professional bodies,

the general public and international stakeholder partners.
The objectives of the management and implementation

arrangements include the following;
• Definition of the various priority actions underlying the
Strategic Plan implementation including spelling out the
responsible parties and their roles in implementation of the
strategic plan.
• Outlining of key strategic activities, their expected outputs
and how their implementation will be measured and reported
on.
• Determination of necessary resource requirements (facilities,
equipment, goods and services) for implementation; and,
• Ascertainment of what systems, policy and procedures
should be put in place to ensure that the strategic plan
implementation process is properly guided.
5.1.2 Implementation Approach
The implementation will be centered on number of

methods and this will include among others the involvement
of human resources, different directorates, as well as different
stakeholders in accordance with the various activities. The staff
have individual performance plans, then directorate plans that
feed into NDA’s annual Work-plans. These will perform as a
foundation for implementing the strategic Plan.
Stakeholder partnerships and collaborations will be put

in place to ensured continued support and improved service
delivery. Where required NDA will prepare draft and sign
74
Memoranda of Understanding (MOU) clearly defining the roles

and responsibilities of each party regarding finances, fees,
coordination, monitoring and reporting.
5.1.3 Implementation Roles and Responsibilities
The Drug Authority shall approve the plan, provide

oversight role and give strategic direction by approving policies
and resources for the implementation of this Strategic Plan.
The NDA shall be accountable for the implementation of

the Strategic Plan.
The management of NDA headed by the respective

Heads of Directorates shall extract the priority actions and
activities earmarked for their leadership in implementation
from the Strategic Plan and develop detailed departmental
and individual action programmes for their implementation.
Structure for implementation of the NDA mandate is attached
as Annex 2 of this plan.
For activities whose implementation require goods and

services which have to be out-sourced, the goods and services
shall be procured by the Procurement and Disposal Unit or its
delegated authority and the coordination of the utilization of the
goods or services done by the user departments.
Task teams may also be formed to address one-off

activities of a strategic nature, which call for participatory action.
5.1.4 Partnerships and collaborations
Partnerships and collaborations with public private

partners, development partners, Civil society organizations,
75
private sector, religious organizations, the public will ensure

the implementation of the strategic plan through the use of
their experience, financial and non -financial supports. NDA
will make linkages with regional and international organizations
so as to strengthen partnerships and collaborations with all its
partners to ensure continued support and improved service
delivery. Where required NDA will prepare draft and sign
Memoranda of Understanding (MOU) clearly defining the roles
and responsibilities of each party regarding finances, fees,
coordination, monitoring and reporting.
76
77
6.0 COMMUNICATION
AND FEEDBACK
MECHANISM
78
The communication and feedback strategy presents the

roadmap that NDA shall take to communicate with and engage
the different stake holders in order to popularize and have this
plan implemented. This is to increase the awareness of the
mandate among both the internal and external stakeholders.
The strategy outlined below seeks to ensure that the plan is
effectively communicated to relevant stakeholders to ease
implementation.
6.1 Objectives of the communication and feedback

mechanism
1. Establish a clear understanding and awareness of NDA’s

mandate amongst all key stake holders.
2. Encourage and attract strategic partners in delivery of
outlined projects.
79
3. Ensure that honest and accurate information is delivered in

an open, effective and timely manner.
4. To ensure the strategic plan is widely disseminated and
share with responsible stake holders.
6.2 Dissemination methods
The methods of dissemination will mainly include but will

not be limited to;
1. Radio and TV talk shows especially on human/vet health
related commemoration days.
2. Sensitization to the public and other stakeholder on the plan
in addition to provision of drug regulatory services.
3. Production and distribution of an abridged version of the
plan.
4. Distribution of copies (main report) to key stake holders.
5. Reproduction and rebranding of the, vision, mission
statement and core values on various categories of IEC
materials.
6. Reciting and communication of vision, mission statement
and care values at every opportunity like during staff
meeting.
6.3 Mechanisms for generating feedback from

stakeholders
1. Publication and sharing of performance reports on websites

and giving feedback channels.
2. Utilizing social media and call center.
3. Holding periodical feedback meetings.
80
Stakeholder feedback.
81
7.0 MONITORING AND

EVALUATION
ARRANGEMENTS
82
This chapter presents the overall monitoring and evaluation

arrangements that will be put in place to continuously ensure
the set-out objectives are achieved.
7.1 Progress Reporting and Review of Results
The performance milestones for assessment of monitoring and

evaluation of NDA’s performance with respect to all the strategies,
outcomes, planned activities, indicators and outputs have been
defined as part of the NDA Strategic Framework provided in this Plan.
Data required to populate the indicators as framed will be collected
through four sources: administrative data, enhanced, when possible,
by field data; a survey of experts; public surveys; and document
reviews.
Management will put in place mechanism for M&E

implementation of the strategic plan. Annually management
83
shall develop workplan and budget the implementation action

plan and the financing arrangement of this strategic plan.
The implementation progress of this strategic plan shall be
monitored and evaluated in the following intervals;
• Quarterly performance reviews.

• Semi-annual performance reviews.
• Annual performance reviews.
• Mid –Term Evaluation.
• End-term Evaluation.
Reports to the Drug Authority and Management

documenting strategic plan activities carried out and the
performance milestones achieved will be produced on a
periodic basis in line with above reporting intervals. The
indictors in the M&E framework will be reported to the Drug
Authority and management. Where necessary the performance
targets and indicators may be reviewed to reflect the evolving
circumstances affecting the performance of NDA.
7.2 Monitoring and Evaluation assumptions
• A comprehensive Monitoring and Evaluation Plan shall be

developed, with the Results Frameworks at both outcome and
output level are presented.
• Timely reporting.
• Stability of macro-socio, economic and political factors.
• The organizational structure is fully resourced.
• A harmonized legal framework is in place.
84
7.3 NDA M&E Results Framework Matrix
Type of Indicator
(FY 19-20 Perf)
Responsibility
Measurement
Performance
Annualized
Baseline
indicator
interval
Targets
20-21
22-23
23-24
24-25
21-22
FY
FY
FY
FY
FY
Goal: To attain and maintain global best practices in drug regulation by 2025.
1. Percentage
of regulato-
ry functions
meeting
Impact
World
Indica- 13% 13% 13% 13% 13% 100% Annual SA-QMS
Health
tor
Organiza-
tion (WHO)
Maturity
Level 3.
Human Capital and Manufacturing Programme
Focus Areas 1: Core Service Delivery:
Strategic Objective: To improve the regulatory efficiency and effectiveness that

ensure safe, efficacious and quality drugs and health products.
Health Outcome1.1: Improved regulatory systems, processes and procedures that

guarantee availability of safe, efficacious and quality drugs and health care products.
2. Proportion
of SDT’s Out-
implement- come Quar-
78% 80% 80% 82% 84% 86% SA
ed within Indica- terly
the agreed tor
timeline.
85
Type of Indicator
(FY 19-20 Perf)
Responsibility
Measurement
Performance
Annualized
Baseline
indicator
interval
Targets
Health Outcome1.2: Improved public access and utilization of safe, efficacious and
quality drugs and health care products
3. Proportion
of improved
Out-
perfor-
come Annu-
mance 59% 65% 70% 75% 80% 85% SA
Indica- al
in core
tor
service
delivery.
Focus Areas 2: Legal and Regulatory Framework:
Strategic Objective: To streamline the legal and regulatory framework for operational
effectiveness of NDA.
Health Regulatory Outcome 2.1: Harmonized legislative framework that enables an

effective and well-functioning regulatory system for drugs and health products,
4. Proportion
of target Out-
4
stakeholder come Quar-
meet- 80% 85% 85% 85% 85% Legal
engaged in Indica- terly
ings
advocacy tor
initiatives.
5. Proportion
of Regula-
tions and Output
Guidelines Indica- 100% 100% 100% 100% 100% 100% Annual Legal
developed tor
and pub-
lished.
86
Type of Indicator
(FY 19-20 Perf)
Responsibility
Measurement
Performance
Annualized
Baseline
indicator
interval
Targets
6. Transfor- Out-
UNF-
mation of come
DA in Year 5 Legal
NDP&A Act Indica-
place
into UNFDA. tor
Focus Areas 3: Stakeholder Engagement and Collaboration:
Strategic Objective: To increase public awareness, and stakeholder collaboration to

support NDA regulatory functions.
Health Regulatory Outcome 3.1: Increased public awareness knowledge and prac-
tices about safety, efficacy and quality of drugs,
7. Propor-
Out-
tion of the
come Annu-
stakehold- 83% 85% 90% 93% 93% 93% SA/PR
Indica- al
ers aware
tor
of NDA role.
Out-
8. Proportion
come Year Annu-
of Satisfied 75% 75% 75% 80% 80% SA/PR
Indica- 4 al
customer.
tor
Health Regulatory Outcome 3.2: Increased positive perception and visibility of NDA
as an effective global standard regulator within the health system.
87
Type of Indicator
(FY 19-20 Perf)
Responsibility
Measurement
Performance
Annualized
Baseline
indicator
interval
Targets
9. Propor-
tion of the
stakehold- Out-
ers that come Annu-
49% 59% 69% 79% 89% 95% SA/PR
perceives Indica- al
NDA as tor
playing her
role.
Focus Areas 4: Institutional Development:
Strategic Objective: To improve NDA institutional capacity to effectively and efficient-

ly implement its functions
Health Regulatory Outcome 4.1: Improved institutional infrastructure and to enable

effective regulatory service delivery and specialized operations
10. % of
planned
Output
institutional Annu-
Indica- TBD 60% 70% 75% 80% 80% DCS
infrastruc- al
tor
ture imple-
mented.
Health Regulatory Outcome 4.2: Increased digital transformation for regulatory
effectiveness.
11. Propor-
tion of
institutional Output
business Indica- 0% 0% 31% 63% 94% 100% Annual DCS-ICT
processes tor
fully auto-
mated.
88
Type of Indicator
(FY 19-20 Perf)
Responsibility
Measurement
Performance
Annualized
Baseline
indicator
interval
Targets
12. Per-
centage
of online
services Out-
accessed come
99% 99% 99% 99% 99% 99% Annual DCS-ICT
throughout Indica-
the year tor
(Uptime
of online
services)
Health Regulatory Outcome 4.3: Increased human resource productivity to deliver
the NDA’s regulatory mandate.
13. propor-
tion of staff
who attain Out-
65% of come DCS/
100% 95% 100% 100% 100% 100% annual
approved Indica- HRA
perfor- tor
mance
targets.
Health Regulatory Outcome 4.3: Improved financial sustainability of NDA
14. % Out- 63,
DCS/
increase in come 217, annu-
+5% +5% +5% +5% +5% Fi-
generated Indica- 753, al
nance
revenue. tor 987
Output 82% DCS/
15. Working annu-
Indica- 90% 90% 90% 90% 90% Fi-
ratio al
tor nance
89
8.0 ENTERPRISE RISK

MANAGEMENT
90
8.1 Risk Management Introduction
This National Drug Authority (NDA) Strategic Plan has

adopted the risk management approach that is consistent
with the Government of Uganda Risk Management Strategy
2018 whose main objective is to facilitate the integration of
risk management into national development planning, strategy
formulation, annual planning and in all systems and processes.
NDA strategic plan 2020-2025 acknowledges the need

for risk informed development as a process and not an event.
This is because there is a continuous interaction across local,
regional and global risks including; Regulatory, Human Capital,
Legal, External, Reputation, Technology, financial, strategic
among others. The plan has therefore identified, analyzed
various potential risks and prescribed possible mitigation,
continuous monitoring and management measures during the
plan period.
91
NDA must employ sound enterprise risk management

principles, transparent decision-making, and effective
communication to prioritize risk. NDA manages nine interrelated
categories of risk to effectively regulate and ensure a safe
and sound regulatory system that supports drug operators,
communities, businesses, and the Ugandan economy.
Management will put in place mechanism including a

policy and framework for risk identification, monitoring and
evaluation to implement the strategic plan. Management will
integrate risk management in all business processes of the
organisation. The implementation progress shall be monitored
and evaluated in the following intervals;
• Quarterly performance reviews.

• Semi-annual performance reviews.
• Annual performance reviews.
Reports to the Drug Authority and Management

documenting risk ouputs out and the performance milestones
achieved will be produced on a periodic basis in line with above
reporting intervals.
NDA accepts some risks in fostering a vibrant, safe and

sound, fair and innovative regulatory system and recognizes it
is not practical or desirable to avoid all risk. NDA must maintain
proactive regulatory approaches that address significant risks
to the human and animal health sectors and its stakeholders,
recognizing the best regulatory processes will not always
prevent regulated parties from experiencing problems or failing.
92
8.2 Risk Profile
Successful management of the risks of NDA will lead to

the achievement of the strategic objectives of this plan. Annually
management will review and update the risk profile/register of the
organization in line with the risk appetite approved by the Drug
Authority. Table Below articulate the key identified risks from the
internal and external context that would potentially affect the
achievement of the strategic objectives enshrined in this plan.
8.3 Summary Matrix of Key NDA Envisaged Risks
Risk Proposed strategic

Descrip- Risk Actions For Addi-
tion & Risk Impact Rating tional Risk Mitiga-
Categori- tion
zation
Strategic Objective 1: To improve the regulatory efficiency and effective-
ness that ensure safe, efficacious and quality drugs and health products.
Existence OPERA- • Failure to • Contribute to the
of sub- TIONAL fulfill the development of a
standard, regulatory National supply chain
falsified mandate. strategy.
and • Damage on • Strengthen collab-
unsafe, oration with MDA
non-ef- reputation
on actions to deter
fective • Financial unauthorized products
products loss due to reaching the market.
on the litigation MAJOR
• Introduce an auto-
market. • ADR mated track and trace
• AMR/APR system.
• Death • Strengthen collabora-
tive enforcement and
intelligence gathering
actions against the
violation of the NDA
law.
93

Categori- tion
zation
Breach of COMPLI- Cancelation of Invest in strength-

Regulato- ANCE WHO and ISO/ ening the Quality
ry service IEC 17025 MODERATE Management Systems
standards. and 9001 ac- across the organiza-
creditations. tion.
Strategic Objective 2: To streamline the legal and regulatory framework for

operational effectiveness of NDA.
Deficien- COM- • Failure to Consider advocacy
cy in the PLIANCE fulfill the actions to streamline
law/regu- regulatory the legal and regu-
latory as mandate. latory framework for
a result • Damage on operational effective-
of the reputation ness.
expanded • Financial
scope of loss due to MODERATE
prod- litigation.
ucts for
regulation
(con-
doms,
masks
etc).
Authority OPERA- • Failure to • Consider actions to

service TIONAL fulfill the streamline the legal
delivery regulatory and regulatory frame-
fail to mandate. work for operational
achieve • Damage on effectiveness.
the reputation. MODERATE • Automate and
agreed • Financial integrate business
stan- loss due to process for timely
dards. litigation. and efficient service
delivery.
94

Categori- tion
zation
Authority COM- • Damage on • Advocacy strate-

sued with PLIANCE reputation. gy should include
signifi- • Financial loss actions to engage key
cant con- to litigation. stakeholders to seek
sequence. MODERATE consensus on neces-
sary revisions.
• Establish a client
charter to address
service gaps.
Strategic Objective 3: To increase public awareness, and stakeholder

collaboration to support NDA regulatory functions.
Damage REPUTA- Damage on • NDA Should proac-

to Rep- TION reputation. tively create response
utation/ plans to quickly
Brand address the public
of NDA relations should a rep-
(Repu- MAJOR
utation event occur.
tational • Streamline communi-
Risk) cation.
• Develop a stringent
fraud policy.
Conflict in STRATE- Failure/delay Strengthen collabo-

regulatory GIC to deliver ration with MDA to
mandate on the NDA enlist their support
occurs. mandate. for on actions to
MODERATE
share information
and deter unau-
thorized products
reaching the market.
95

Categori- tion
zation
Strategic Objective 4: To improve NDA institutional capacity to effectively

and efficiently implement its functions
Economic STRATE- • Failure to • Monitor the Mac-

Slow- GIC fulfill the ro-economic condi-
down/ regulatory tions.
Slow mandate. • Conduct rigorous
Recovery • Business stress tests and con-
(Especially
because of failure. sidering hypothetical
COVID-19). scenarios to assess
NDA’s ability to
MODERATE weather an econom-
ic downturn.
• Review the financial
projection to reflect
the Macroeconomic
effect.
• Continued re-engi-
neering of business
processes.
Staff OPERA- • Injuries • Enhance occupation-

Safety, TIONAL • Death al health and safety
Security • Litigation actions.
And and com- EXTREME • Improve on the work
Health pensation space and environ-
hazard
occurs. cost. ment.
96

Categori- tion
zation
Cyber At- TECHNO- • Denial and • Scale up the disaster

tack/Data LOGICAL disruption recovery plan.
Breach. of business • Increase internal
operations. awareness of cyber
• Increased related threats.
cost of oper- EXTREME • Acquire more fire-
ation. walls.
• Client dissat-
isfactions.
• Financial
losses.
Business/ FINAN- Business Strengthen resource

Financial CIAL failure. mobilization.
perfor-
mance
leading to
MODERATE
cashflow
fluctu-
ations/
liquidity
risk.
Failure OPERA- • Cancelation • Review of staff

to Attract TIONAL of accredita- reward system to pe-
and/Or tions. riodically align with
Retain • Damaged regulatory needs.
Top repetition. • Improve succession
Talent/
Human MODERATE planning.
resource • Improve the staff
risk. structure that is
competitive with
other Government
bodies.
97

Categori- tion
zation
Third par- OPERA- • Failure to MAJOR • Strengthen third

ty service TIONAL deliver on party due diligence
providers mandate. review processes.
fail to • Disruption of • Improve contract
perform. operations. management moni-
• Financial toring and reporting
loss mechanisms.
• Litigations
Shortage OPERA- • Failure to MOD- Review and procure-

of Infra- TION fulfill the ERATE ment of infrastructure
structure regulatory and tooling needs to
and mandate. periodically align with
facilities • Damage on regulatory needs.
to meet reputation.
the NDA’s • Financial
needs. loss to litiga-
tion.
98
KEY TO QUANTITATIVE RISK RATING
Almost Certain 5 10 15 20 25
Likely 4 8 12 16 20
Likelihood
Moderate 3 6 9 12 15
Unlikely 2 4 6 9 10
Rare 1 2 3 4 5
Insignifi-
Minor Moderate Major Extreme
cant
Consequence
99
9.0 PROJECT
PROFILES
100
Under this strategic plan National Drug Authority (NDA)

plans to undertake a number of projects that are of a capital
nature in infrastructure and equipment critical to implementation
of NDA mandate. A summary of the investment projects to be
undertaken are given in the matrix on the next page.
101
NATIONAL DRUG AUTHORITY INVESTMENTS SUMMARY
No Project Name Already Project Estimated Project Cost

Existing in Location Ugx
Strategic Plan
2016-2020
Construction of Plot 93,

1 the Laboratory Yes Buganda 36,983,334,694
Tower. Road
Office
Specification, Plot 93,
2 design, and No Buganda 33,960,714,192
fitting of the Road
administrative
space.
Equipping of Plot 93,

3 the Laboratory No Buganda 77,626,400,000
space. Road
Construction
4 of 2 regional No Regions 4,000,000,000
offices.
Scale up
automation Plot 93,
5 and integration Yes Buganda 20,155,182,500
of Business Road
Processes.
Total 171,794,631,386
102
Funding Expenditure Up Current Stage Project Funding Gap

Committed to FY 2019/20 Of The Project Duration
Construction of
36,983,334,694 5,756,617,453 the First floor FY
out of the 12 2021/22 -
floors.
31,788,697,892 - Not yet FY 2,172,016,300

commenced. 2021/22
- Not yet FY 77,626,400,000

- commenced. 2024/25
Land FY
4,000,000,000 - acquisition 2023-24 0
processes.
Partially
automated;
Premise,
6,781,801,220 - licensing, FY 13,373,381,280
Import and 2020-25
export, Product
and GMP
modules.
79,553,833,806 93,171,797,580
103
ANNEXES
104
Annex 1: Detailed Output Level Result framework
ANNUAL TARGETS
PARTY
FY
FY
FY
FY
FY
OUTPUT
OUTPUT
ACTIONS
TARGETS
MEANS OF
ACTIVITIES
STRATEGIC
2020/21
2021/22
2022/23
2023/24
2024/25
INDICATORS
VERIFICATION
RESPONSIBLE
Strategic Objective 1 : To improve the regulatory efficiency and effectiveness that ensure safe, efficacious and quality drugs
and health products.
Strategic Intervention 1.1: Strengthen systems and institute regulatory actions that support local drugs manufacturing.
1.1.1.1
Develop
framework Framework
to support for action
local phar- 1 frame- to support
Framework DIE
maceutical work local GMP
developed
industries Drafted. require-
meet GMP ments/
require- standards.
ments/stan-
dards.
1.1.1.2 Number of 16 stake- 4 held 4 held 4 held 4 held Stake- DIE

Support stakehold- holder holder en-
quarterly lo- er engage- engage- gagement
cal medicine ments held ments report.
held
manufac-
1.1.1: turers and
Strengthen policy level
mecha- stakeholder
nism to engagement
support events.
actions for
local drug 1.1.1.3 Number of one per
Support do- inspec- manu- one per one per one per one per one per Quarterly
manufac- tions per manu- manu- manu- manu-
turing. mestic man- manufac- facturer facturer facturer manufac- facturer facturer cGMP DIE
ufacturers to turer @ yr @ yr @ yr turer @ yr @ yr @ yr training
comply with Number of 5 train- 1 held 1 held 1 held 1 held 1 held report
cGMP. trainings. ings
1.1.1.4 160 man-

inspect Number of Quarterly
ufactures
premises for manu- 40 x 2 40 x 2 50 x 2 60 x 2 70 x 2 cGMP
inspected DIE
manufac- factures a year a year a year a year a year training
ture of local twice a
inspected report.
herbal drugs. year
1.1.1.5.
Pre market
INSPECTION Number of 60 60 70 80 90
360 in-
for NEW inspection inspec- inspec- inspec- inspec- inspec- DIE
locally man- spection
conducted. tion tion tion tion tion
ufactured
products.
1.1.1.6.
Training of 9
Number of Quarterly
local man- trainings 1 con- 2 con- 2 con- 2 con- 2 con-
trainings QC training DLS
105
ufactures conduct- ducted ducted ducted ducted ducted

in quality conducted report.
ed
control.
106
ANNUAL TARGETS PARTY
FY
FY
FY
FY
FY
OUTPUT
OUTPUT
ACTIONS
TARGETS
MEANS OF
ACTIVITIES
STRATEGIC
2020/21
2021/22
2022/23
2023/24
2024/25
INDICATORS
VERIFICATION
RESPONSIBLE
Strategic Intervention 1.2: Strengthen systems and institute actions that support drug regulatory compliance by human and vet
practitioners.
1.2.1: 1.2.2.1 Number of

2500
Strengthen Conduct and collabora- 500 sub- 500 sub- 500sub- 500 sub-
sub-co 500 sub-
collabora- document tive pro- co co co co
UVB/UVA co Quarterly
tive pro- collaborative grammes/ UVB/UVA UVB/UVA UVB/UVA UVB/UVA
10 UVB 2 stake- Vet
grammes programme/ meetings 10 10 10 10
MAAIF 10 MAAIF 2 holder en- Product/
with vet meeting shared MAAIF 2 MAAIF 2 MAAIF 2 MAAIF 2
250 50 gagement DPS
profes- among with 50 50 50 50
districts districts report.
sional targeted targeted districts districts districts districts
extension extension.
bodies, stakehold- stakehold- extension. extension. extension. extension.
workers.
MDA, local ers. ers.
govern-
ment, and
vet prac- 1.2.1.2 Con-
titioners duct a study Number of
to ensure to collect studies to
safety, ef- data to un- under- RDU Vet
5 studies
ficacy and derstand the stand the 1 vet 1 vet 1 vet 1 vet 1 vet Research Product/
vet
quality and magnitude magnitude Report. DPS
enhance of the prob- of RDU
rational vet lem of RDU conducted.
drug use. w.r.t.R.D.U.
1.2.1.3.
Establish a
collaborative
documen- Vet
tation and MOU Signed
reporting signed 2 MoU 1 MoU 1 MoU Product/
MOU
modality DPS
with MAAIF
& local gov’t
for RDU.
Number of
Pharma-
1.2.1.4. covigilance
Provide for TOTs and
adequate support 4 ses- Vet
mechanisms supervision sions vet Field
to foster visits paid 1 session 1 session 1 session 1 session Product/
reports
functionality to regional TOTs DPS
of Pharma- centres
covigilance. and vet
catchment
facilities.
1.2.1.5.
Attend
Regional/
international
Collaboration Number of
technical technical 25
Minutes of
working working meetings 5 5 5 5 5 VET
meeting to meetings meetings.
attended
support staff attended.
in improving
107
skills in vet
drug regula-
tions.
ANNUAL TARGETS
108
PARTY
FY
FY
FY
FY
FY
OUTPUT
OUTPUT
ACTIONS
TARGETS
MEANS OF
ACTIVITIES
STRATEGIC
2020/21
2021/22
2022/23
2023/24
2024/25
INDICATORS
VERIFICATION
RESPONSIBLE
1.2.2: 1.2.2.1 Collabora-

Strengthen Develop and tion agen-
collabora- disseminate da with Minutes of
DPS
collaboration MoH/PNFP meetings.

tive pro- agenda with developed.
grammes MoH/PNFP.
with
human 1.2.2.2. Number of
health pro- Provide for Pharma-
covigilance
fessional adequate TOTs and 7
bodies, mechanisms support
supervi- sessions
MDA, local to foster 2 ses- 2 ses- 2 ses- 1 ses- Field
function- sion visits human DPS
govern- paid to sions sions sions sions reports
ality of public
ment, regional
Pharm-covig- centres facilities.
private and
clinical ilance.
catchment
practi- facilities.
tioners to Number of
ensure Pharma-
safety, ef- covigilance
TOTs and
ficacy and support 8
2 ses- 2 ses- 2 ses-
quality and supervi- sessions 1 session 1 session DPS
sion visits TOTs sions sions sions
enhance paid to pri-
rational vate sector
human health
drug use facilities.
Number
of Annual
Pharma-
covigilance
feedback 5 meet- 1 meet- 1 meet- 1 meet- 1 meet- 1 meet- Minutes of
meeting DPS
and stake- ings ing ing ing ing ing meetings.
holder
sensi-
tization
meeting.
Number of
Joint CPDs Number of
with UMA, Joint CPDs
UNMC,
Allied pro- 5 CPD with UMA,
fessional, 5 CPD DPS
UDA, PSU
UDA, PSU on Pharma-
on Phar-
macovigi- covigilance.
lance.
1.2.2.3.
Implement Number
collabora- of MOUs
tion actions between 4 MoUs
with health health pro- devel- Signed
professional fessional 4 MoUs DPS
MoUs.
bodies to bodies oped.
enhance & NDA
rational drug signed.
use.
1.2.2.4. 40 Minutes of
Attend meetings 8 8 8 8 8 meetings. DIE
Regional/ attended.
international
Collaboration 25 Minutes of
technical meetings 5 5 5 5 5 meetings. DPS
working attended.
meeting to
109
support staff 25
in improving meetings 5 5 5 5 5 Minutes of DPAR
skills in drug attended. meetings.
regulations
ANNUAL TARGETS
110
PARTY
FY
FY
FY
FY
FY
OUTPUT
OUTPUT
ACTIONS
TARGETS
MEANS OF
ACTIVITIES
STRATEGIC
2020/21
2021/22
2022/23
2023/24
2024/25
INDICATORS
VERIFICATION
RESPONSIBLE
7000
1.2.3.1 Number
GDP
Conduct GDP of GDP in- 720 720 720 1,440 1,440 DIE
inspec-
inspections. spections.
tions.
4800
1.2.3.2 Number
GPP
Conduct GPP of GPP in- 250 250 250 1000 1000 DIE
inspec-
inspections. spections.
tions.
1.2.3: Number 40 Vet

1.2.3.3
Strengthen of GVP in- GVP DPS/PV/
Conduct GVP 10 10 10 10
mecha- spections inspec- VET
inspections.
nisms that (Vet). tions.
support
compli-
ance with
GDP, GPP,
GVP, GCP.
80 in-
spections
1.2.3.4 Number 16 16 16 16 16
(Human) DPS/CT/
Conduct GCP of GCP in-
84 in- VET
inspections. spections. 4 20 20 20 20
spections
Vet.
Strategic Intervention 1.3: Strengthen the research capacity for making evidence-based drug regulatory decisions.
1.3.1.1 Framework
Develop the to facilitate
framework 2 frame pro-active
Research
to support work ethical
Framework Agenda DPS/DIE/
evidence- docu- research
document - DPAR/
based drug ments agenda on
developed. Research DLS
regulatory devel- medicines
policy.
research oped. & health
and decision care prod-
making. ucts.
1.3.1
Establish
20
mecha- 1.3.1.2 Im-
research Research
nisms to plementation Number of 3 re- 4 re- 4 re- 4 re- 4 re-
studies report on DPS/DIE/
support of evidence researches searches searches searches searches searches
on reg- medicines DPAR/
evidence - -based drug undertak- conduct- conduct- conduct- conduct- conduct-
ulatory and health DLS
based drug regulatory en. ed ed. ed. ed. ed.
research products.
regulatory research.
conducted.
research
and
decision 1.3.1.3
5
making. Building staff Number of 1 training 1 training 1 training 1 training 1 training
trainings Training
capacity in trainings conduct- conduct- conduct- conduct- conduct- DPS
conduct- reports.
Research conducted. ed. ed. ed. ed. ed.
ed.
methods.
1.3.1.4
Publishing Number of
Research
of results for research 10 publi-
2 Pub 2 Pub 2 Pub 2 Pub 2 Pub publication DPS
111
completed publica- cations.

links.
research tions.
studies.
ANNUAL TARGETS
112
PARTY
FY
FY
FY
FY
FY
OUTPUT
OUTPUT
ACTIONS
TARGETS
MEANS OF
ACTIVITIES
STRATEGIC
2020/21
2021/22
2022/23
2023/24
2024/25
INDICATORS
VERIFICATION
RESPONSIBLE
Strategic Intervention 1.4: Strengthen the systems, processes and procedures for pre-market authorization of drugs and
1.4.1. 9300
Strengthen 1.4.1.1. Dossier
Evaluation Number Evaluation
mecha- Human & Human & 1800 Health
nism for Veterinary of timely Veterinary 1800 1850 1900 1950
drugs new product drugs, Evalua- Evalua- Evalua- Evalua- Evalua- products DPAR
regulation applica- quality of tions. tions. Evaluation
of product evaluations inclusive tion s. tions tion. report.
tions and conducted. additional
assess- Additional infor-
ment and information. mation
evaluation.
evaluation,
authoriza- Number Six (6) Six (6)
tion and of 5 day Twenty Four (4) five day Six (6) Six (6) five day
1.4.1.2. 5 Hands on eight (28) five day Hands on five day five day Hands on
conduct day Hands five day Hands on
of clinical on Dossier Dossier assess- assess- Dossier assess- assess- Dossier DPAR
assessment assessment ment assessment ment assess-
and field ment sympo- ment sympo- ment
symposium. sympo- sympo- sium. sympo- sympo- sium. sympo-
trials for sium. sium.
drugs and sium. sium. sium.
health care
products. 1.4.1.3. Number of Thirty four Four (4) Six (6) Eight (8) Eight (8) Eight (8)
Participate in Joint As- (34) joint joint as- joint as- joint as- joint as- joint as-
[contd...] EAC, IGAD, sessment assess- sessment sessment sessment sessment sessment
and WHO meetings ment meeting meeting meeting meeting meeting
CRP Joint conducted. meeting reports. reports. reports. reports. reports.
Assessment reports
meetings. (EAC, DPAR
IGAD, and
WHO CRP).
960 (400
1.4.1.4. Foreign & 190 (80 200 (80 210 (80
Conduct the Number of 530 local Foreign & Foreign & Foreign &
Evaluation of foreign, lo- (herbal) 180 (80 180 (80 100 local 110 local 120 local Health
foreign and cal herbal and 30 Foreign & Foreign & (herbal) (herbal) (herbal) products
local herbal medicines other 100 local 100 local and 10 and 10 and 10 Evaluation DPAR
medicines and other health (herbal). (herbal). other other other
and other healthcare care health health health report.
healthcare evaluated. products care care care
products. evaluat- products. products. pdts.
ed).
Reference
1.4.1.5.
Purchase of Number of materials/
reference Reference 05 (As- 01 (As- 01 (As- 01 (As- 01 (As- 01 (As- sites/
materials materials sorted) DPAR
sorted) sorted) sorted) sorted) sorted) financial
and online procured. docu-
subscription.
ments.
1.4.1.6.
Implement
actions, pro-
cesses and
procedures
that support
continued Number of
improvement facilities
in validation inspected Inspection
of imported for com- 1140 190 215 230 245 260 DIE
products, reports.
including pliance to
foreign herb- GMP.
al, food for-
tificants and
premixes,
CROs and
APIs for GMP
113
compliance.
ANNUAL TARGETS
114
PARTY
FY
FY
FY
FY
FY
OUTPUT
OUTPUT
ACTIONS
TARGETS
MEANS OF
ACTIVITIES
STRATEGIC
2020/21
2021/22
2022/23
2023/24
2024/25
INDICATORS
VERIFICATION
RESPONSIBLE
1.4.1.7. Reg- 175 New

ulate clinical CT evalu- 35 CT 35 CT 35 CT 35 CT 35 CT
and field trial
approvals ations
to maximize Number of 25 field
CTA
safety and CTA eval- trial eval-
facilitate uations 1 FT 4 FT 5 FT 9 FT evaluation DPS
uations
access to reports.
new med- conducted. 700 post
approval
icines and CT evalu- 140 140 140 140 140
healthcare ations.
products.
1.4.1. 1.4.1.8. Numbers

Strengthen Amend of amend- Amend-
legal pro- ments to
mecha- visions and ed legal
legal provi- To LEGAL DPS
nism for regulations sions and provisions
regulation requiring passed.
researchers. regulations
of product approved.
assess-
ment and 1.4.1.9. Es-
evaluation, tablish and
authoriza- operational-
ize advisory An advi-
tion and committees
conduct sory CT
for review of committee
of clinical CT/FT appli- put in
and field cations and place 40 meet- 8 meet- 8 meet- 8 meet- 8 meet- 8 meet- Minutes of
trials for pre and post Advisory DPS
approval ings. ings. ings. ings. ings. ings. meetings.
drugs and com-
safety and mittees
health care compliance meetings
products. issues. held.
Collab-
oration 20 CT
4 CT 4 CT 4 CT 4 CT 4 CT
meetings meetings.
DPS
with CT 10 FT
2 FT 2 FT 2 FT 2 FT 2 FT
stakehold- meetings.
ers.
Strategic Intervention 1.5: Strengthen the systems, processes and procedures for post-market authorization of drugs and healthcare products.
5930
1.5.1.1. Con- Variations
duct Human (Inclusive
& Veterinary of major,
Medicines minor Evaluation
Number
1.5.1 variation ,notifica- 970 1200 1200 1260 1300 DPAR
applications evaluated. tion) and reports.
Improve and variation variation
systems additional additional
for effec- information. informa-
tive control tion.
of imports
and
exports. 1.5.1.2.
Maintain a Number
[contd...] 60 Drug 12 Drug 12 Drug 12 Drug 12 Drug 12 Drug
current and of register Update
registers registers registers registers registers registers
up to date publi- publi- publi- publi- publi- publi- drug DPAR
publi- register.
drug register cations cized. cized. cized. cized cized.
cized.
(Registers made.
published).
115
ANNUAL TARGETS
116
PARTY
FY
FY
FY
FY
FY
OUTPUT
OUTPUT
ACTIONS
TARGETS
MEANS OF
ACTIVITIES
STRATEGIC
2020/21
2021/22
2022/23
2023/24
2024/25
INDICATORS
VERIFICATION
RESPONSIBLE
Number
of herbal
stakehold- 64 train- Training
er training/ ings. 8 8 16 16 16 DPAR
reports.
meetings
held.
Number
1.5.1.3. of herbal Field
Stakeholder bench- 16 visits. 2 2 4 4 4 DPAR
marking reports.
engagement
on human, visits held.
vet, herbal Number
and health of human
care prod- and vet
ucts. 16 train- Training
stakehold- 2 2 6 6 6 DPAR
er training/ ings. reports.
meetings
held.
Scientific
1.5.1 engage- 20 train- Training
ment 4 4 4 4 4 DPAR
Improve ings. reports.
trainings.
systems
for effec- Proportion
tive control 1.5.1.4. of applica-
Verification tions veri- Verification
of imports import and fied within 100% 100% 100% 100% 100% 100% DIE
and ex- exports ap- SDT of 2 Reports.
ports. plications. working
days.
Proportion
of consign-
1.5.1.5. ments
Inspection inspect-
of con- ed and Inspection
signments regulatory 95% 95% 95% 95% 95% 95% DIE
decision Reports.
at ports of issued
entry. within 2
working
days.
1.5.1.6.
Batch sam- Proportion
batches DIE
pling at ports of
sampled.
of entry.
1.5.1.7. Number of
stakeholder stake-
engagement 5 meet- Minutes of
for export- holder 1 1 1 1 1 DIE
meetings ings. meetings.
ers/import- held.
ers.
1.5.2.1.
Stakeholder Number of 80
engagement stake- meetings Minutes of
on product holder 16 16 16 16 16 DIE
on quality, meetings (human & meetings.
1.5.2: efficacy and held. vet).
Enhance safety.
systems
for PMS. 1.5.2.2.
[contd...] Sampling
of drugs, Number Quarterly
health care of batches 5,650 800 1,040 1,150 1,260 1,400 DIE
Reports.
117
products sampled.
and medical
devices.
118
FY
FY
FY
FY
FY
OUTPUT
OUTPUT
ACTIONS
TARGETS
MEANS OF
ACTIVITIES
STRATEGIC
2020/21
2021/22
2022/23
2023/24
2024/25
INDICATORS
VERIFICATION
RESPONSIBLE
80
market
Number surveil-
1.5.2.3. of market lance op- Surveil-
surveil- erations 16 con- 16 con- 16 con- 16 con- 16 con-
Market sur- lance DIE/VET
lance (human, ducted ducted ducted ducted ducted
veillance. operations herbal, reports.
conducted. vet,
medical
devices).
Number
of market
1.5.2: 1.5.2.4. surveil- 40 Surveil-
Enhance target vet lance market 8 con- 8 con- 8 con- 8 con- 8 con-
lance DIE/VET
systems products operations surveil- ducted ducted ducted ducted ducted
lance. reports.
for PMS. surveillance. conducted
on the
farm.
100% of
Propor-
1.5.2.5. com- Com-
tion of
Follow up on complaint plaint plaint’s in-
and 100% 100% 100% 100% 100% DIE
complaints and recall vestigation
recall
and recalls. followed followed Reports.
up. up.
1.5.3.1. Test
Conventional No. of 80%
pre-market samples samples Certificates
medicine tested vs. tested vs 400 400 400 400 400 DLS
samples of Analysis.
(PoE)- Hu- Received. received.
man.
1.5.3.2 Test
Conventional
pre-market No. of
medicine samples Certificates
samples tested vs. 200 200 200 200 200 DLS
of Analysis.
(PoE)- Veter- Received.
1.5.3. inary- Acari-
Strengthen cides.
systems, 1.5.3.3 Test
process- Vet vaccines No. of 500
es and and other samples Certificates
tested vs. samples 100 100 100 100 100 DLS
procedures veterinary tested. of Analysis.
for testing medicines Received.
(PMS).
drugs and
health care 1.5.3.4.
products. Test Herbal No. of 1150
medicine samples Certificates
[contd...] samples tested vs. samples 200 200 200 250 300 DLS
tested. of Analysis.
(PMS) sam- Received.
ples.
1.5.3.5. Test No. of
Microbiology samples 700 Certificates
samples tested vs. samples 100 100 200 300 DLS
(PMS)sam- tested. of Analysis.
ples. Received.
1.5.3.6. Test No. of
Conven- 2300
119
samples Certificates
tional PMS tested vs. samples 400 400 400 500 600 DLS
medicine tested. of Analysis.
samples. Received.
ANNUAL TARGETS
120
PARTY
FY
FY
FY
FY
FY
OUTPUT
OUTPUT
ACTIONS
TARGETS
MEANS OF
ACTIVITIES
STRATEGIC
2020/21
2021/22
2022/23
2023/24
2024/25
INDICATORS
VERIFICATION
RESPONSIBLE
1.5.3.7 Test No. of 300

pre- market samples Certificates
samples 60 60 60 60 60 DLS
conventional tested vs. of Analysis.
tested.
samples. Received.
1.5.3.8 No. of 500 Certificates

Test LLINs samples DLS
samples 100 100 100 100 100
samples. tested vs. of Analysis.
tested.
Received.
1.5.3.9 Test No. of
surgical samples
instruments tested vs.
samples; Received.
1.5.3.
Strengthen No. of
325 Certificates
samples DLS
systems, a) Sutures samples 50 50 50 75 100
tested vs. of Analysis.
process- Received tested.
es and
procedures No. of
samples 325 Certificates
for testing b) Needles samples 50 50 50 75 100 DLS
drugs and tested vs. of Analysis.
tested.
Received.
health care
products. No. of
[contd...] samples 325 Certificates
c) Syringes tested vs. samples 50 50 50 75 100 DLS
Received tested. of Analysis.
No. of 200
d) Face- samples Certificates
tested vs. samples 50 50 50 50 DLS
masks tested. of Analysis.
Received.
No. of 200
e) RDTs tested vs. samples 50 50 50 50 DLS
Received.
No. of 2350
f) Condoms tested vs. samples 450 450 450 500 500 DLS
Received.
No. of 1000
g) Medical samples Certificates
tested vs. samples 200 200 200 200 200 DLS
Gloves tested. of Analysis.
Received.
Equipment
in good Equipment
working 80% of in good
1.5.3.10. conditions, 80% of working
all equip- all equip-
Calibration, certifi- ment ment order.
qualification, cates/ calibrat- calibrat- Calibration
reports for ed, qual- ed, qual- 80% of 80% of 80% of 80% of DLS
maintenance calibration, / main-
of lab equip- mainte- ified and ified and tenance
ment. nance main- main- certificates
/ quali- tained.
tained. / reports.
fication
available.
Number
1.5.3.11. Number of of satis- 1 satis- 2 satis- 1 satis- 1 satis- 2 of sat-
Strengthen satisfac- Audits
factory factory factory factory factory isfactory DLS
the Lab QMS tory audits reports.
audits audit. audits. audit. audit. audits.
system. attained.
121
attained.
ANNUAL TARGETS
122
PARTY
FY
FY
FY
FY
FY
OUTPUT
OUTPUT
ACTIONS
TARGETS
MEANS OF
ACTIVITIES
STRATEGIC
2020/21
2021/22
2022/23
2023/24
2024/25
INDICATORS
VERIFICATION
RESPONSIBLE
1.5.3. 1.5.3.12.
Strengthen Attend
systems, Collaboration
process- technical Number of
es and working technical 20 Minutes of
meeting to working meetings 2 4 4 4 4 DLS
procedures support staff meetings attended. meetings.

for testing in improving attended.
drugs and skills in
health care quality con-
products. trol activities.
1.5.4.1Train- 730
ing of trainings
stakeholders Number of conduct- DIE
on licensing trainings ed over 146 146 146 146 146
compliance conducted. the 5
procedures. year.
1.5.4.2. Con- 2,190

duct support trainings
visits per Number conduct-
district on of visits ed over 438 438 438 438 438 DIE
licensing conducted.
compliance. the 5
year.
1.5.4.3Vet
targeted
compliance Number 400
monitoring of target target 80 80 80 80 80 DIE/VET
and support districts
supervision visited. visited.
visits per
district.
1.5.4: 1.5.4.4. 80 intelli-
Strengthen Conduct gence led
Number of 16 16 16 16 16
system, enforcement opera-
enforce-
process inspections tions
ment in- DIE
by the 80
and proce- spections
center. regional 16 16 16 16 16
dures for conducted.
opera-
enforce- tions.
ment of
laws and 1.5.4.5.
regula- Number of
Conduct 120
tions. enforce-
enforcement regional
ment in- 24 24 24 24 24 DIE
inspections opera-
spections
by the tions.
conducted.
regions
1.5.4.6. Number
District of DADIs
Assistant facilitated
Inspector of to conduct
Drugs con- actions
149 facil- 149 149 149 149 149 DIE
duct actions that
itated.
that support support
regulatory regulatory
compliance. compli-
ance.
1.5.4.7. Proportion 70% of

Prepare of case file case file
and submit handled handled 70% 70% 70% 70% 70% DIE
case files for for prose- for pros-
persecution. cution. ecution.
123
ANNUAL TARGETS
124
PARTY
FY
FY
FY
FY
FY
OUTPUT
OUTPUT
ACTIONS
TARGETS
MEANS OF
ACTIVITIES
STRATEGIC
2020/21
2021/22
2022/23
2023/24
2024/25
INDICATORS
VERIFICATION
RESPONSIBLE
1.5.5: 1.5.5.1: De-

Enhance velop MoUs
coordina- for coordi-
tion and nation and
part- partnership
nership schemes Number
MoUs
schemes with relevant of MoUs 5 1 1 1 1 1 1
signed.
with rele- agencies for developed.
vant agen- improved
cies for drug surveil-
improved lance.
drug sur-
veillance.
1.5.6: AMR 1.5.6.1

relevant Implement
National AMR action
Action Plan plan on
integrated
in the NDA drugs in 8 collab-
Number 2 2 2 2 AMR
annual collaboration orative
of AMR activities activities activities activities collabora-
plans for with relevant activities DPS
imple- actions im- imple- imple- imple- imple- tive activity
stakeholders imple-
mented on plemented. mented. mented. mented. mented. report.
and MDAs mented.
collab-
orative under the
basis with National
relevant AMR action
MDAs. plan.
1.5.6.2
Final
Development
Engage- strategy
of drug and Strategy
Strategy Draft ment of devel-
substance docu- DPS
developed. strategy. stake- oped and
abuse ment.
holders. pub-
prevention
lished.
strategy.
1.5.6.3
Engage in- Reports on
stitutions on Number of
160 insti- 20 insti- 30 insti- 30 insti- 40 insti- 40 insti- engage-
prevention institutions DPS
of drug and tutions. tutions. tutions. tutions. tutions. tutions. ment
engaged.
substance activities.
abuse.
1.5.7.1. Engage-
Development ment of
Strategy
of control of Strategy stake- Strategy
drug pro- devel- DPS/PR
motion and developed. holders document.
1.5.7. oped.
on the
Strengthen publication
strategy. strategy.
system,
processes 1.5.7.2. Number of
and proce- Engage- meetings
dures for ment with held with
regulation stakeholders drug
of drug on good advertis- 20 meet-
practices of ers and 4 meet- 4 meet- 4 meet- 4 meet- 4 meet- Minutes of
advertise- publication promoters, ings to DPS/PR
ings held. ings. ings. ings. ings. meetings.
ments. and adver- and other be held.
tisement. stake-
holders
on best
125
practices.
ANNUAL TARGETS
126
PARTY
FY
FY
FY
FY
FY
OUTPUT
OUTPUT
ACTIONS
TARGETS
MEANS OF
ACTIVITIES
STRATEGIC
2020/21
2021/22
2022/23
2023/24
2024/25
INDICATORS
VERIFICATION
RESPONSIBLE
Strategic Objective 2 : To streamline the legal and regulatory framework for operational effectiveness of NDA.
Strategic Intervention 2.1: Advocate for an improved regulatory framework.

2.1.1: Advocacy Advocacy

Advocacy
Advocacy strategy strategy Strategy
strategy SA/Legal
strategy 2.1.1.1: docu- devel- document.
developed.
to include Develop ment. oped.
actions to advocacy
influence strategy and
Annual
necessary implement Implement Imple- Imple- Imple- Imple-
reports of
changes in the strategy. the strat- ment the ment the ment the ment the SA/Legal
advocacy
the legal egy. strategy. strategy. strategy. strategy.
strategy.
framework.
Strategic Intervention 2.2: Strengthen the regulatory framework
95 % of
Proportion regu-
2.2.1.1. of regu-
2.2.1: lations,
Review lations,
Strengthen guide- Annual
and update guidelines
regulatory lines and 75 % 80 % 85 % 90 % 95 % SA/Legal
regulations, and SOPs reports.
require- SOPs
guidelines reviewed
ments. reviewed
and SOPs. and up- and
dated updated.
Strategic Objective 3: To increase public awareness, and stakeholder collaboration to support NDA regulatory functions.
Strategic Intervention 3.1: Strengthen mechanisms for stakeholder awareness and engagement.
3.1.1.1
Develop an
IEC, PR and
stakeholder Number of 30 stake-
6 6 6 6 6
engagement stakeholder
engage- engage- engage- engage- engage- Minutes of
strategy to holder engage- PR Office
ments ments ments ments ments meetings.
foster clarity meetings ments
held. held. held. held. held.
and offer held. held.
guidance
on NDA’s
3.1.1: mandate.
Enhance 3.1.1.2
stake- Developing 10 tools
holder communi- including
Number of
awareness cation tools/ bro- Materials/
commu-
and en- channels for chures, tools
nication 2
gagement. disseminat- bill- 2 2 2 2 developed
tools/
[contd...] ing informa- boards, and dis-
channels
tion about Newslet- tributed.
developed.
synergies for ters de-
NDA stake- veloped.
holders.
3.1.1.3. Sen-
Number of
sitize stake- 20 sen-
sensi-
holders on sitization Sensation
tization 5 5 5 5 5 PR
NDP/A Act, meetings report.
127
meetings
mandate and held.
held.
functions.
ANNUAL TARGETS
128
PARTY
FY
FY
FY
FY
FY
OUTPUT
OUTPUT
ACTIONS
TARGETS
MEANS OF
ACTIVITIES
STRATEGIC
2020/21
2021/22
2022/23
2023/24
2024/25
INDICATORS
VERIFICATION
RESPONSIBLE
Number of 40 media Field

3.1.1.4 Con- reports
media en- engage-
duct media
gagements ments 8 8 8 8 8 and media
engage-
carried under- stories
ments.
out. taken. published.
3.1.1.5. Number of 40,000
Publish and publica- publica-
disseminate tions/ IEC tions/ IEC Publication
4000 2000 6000 3000 5000 PR Office
information materials materials documents
generated at dissemi- dissemi-
NDA. nated. nated.
3.1.1.6.
Define and Number of
implement following
an effective online with
500,000
online and regular so- Number of
3.1.1: followers
digital com- cial media followers
Enhance on Twit-
munications pres-
stakehold- ter and 100,000 100,000 100,000 100,000 100,000 on Face-
strategy that ence on
er aware- Facebook book and
is focused Facebook,
ness and plat- Twitter.
on the needs Twitter,
forms.
engage- and expecta- WhatsApp
ment. tions of key and Insta-
stakeholder gram.
groups.
3.1.1.7.
Analyze
and share
Number of
statistics
statistical Publication
arising from 5 1 1 1 1 1 PR Office
reports documents
information
shared.
flowing
through the
Organization.
3.1.1.8.
Monitor
brand
awareness
trends and Sys-
levels of Uniform Branding
trust among tematic New staff All 2 Staff
Strengthen staff at the Enhance
the general branding uniform company customer
public and Corporate email front corporate PR Office
strategy pro- vehicles care
carry out brand. signa- desk im- brand.
further devel- duced. branded training.
oped. ture. proved.
bespoke uniformly.
research
among key
stakeholder
groups.
3.1.2:
Enhance Number of
drug regu- 3.1.2.1. media en-
latory IEC Dissemi- gagements 100 20 20 20 20 20
program nate public on relevant media media media media media media Field re-
target information
sharing in- drug engage- engage- engage- engage- engage- engage- ports and PR
on relevant
formation laws and ments ments ments ments ments ments agree-
drug laws
with public regulations held. held. held. held. held. held. ments.
and regula- carried
129
on topic tions.
issues. out.
[contd...]
ANNUAL TARGETS
130
PARTY
FY
FY
FY
FY
FY
OUTPUT
OUTPUT
ACTIONS
TARGETS
MEANS OF
ACTIVITIES
STRATEGIC
2020/21
2021/22
2022/23
2023/24
2024/25
INDICATORS
VERIFICATION
RESPONSIBLE
3.1.2.2. Plan
and imple-
ment regular
3.1.2: engagement
Enhance and informa-

drug regu- tion sharing
No of
latory IEC actions with
monthly 1
program stakeholders 12 12 12 12 12
meetings monthly Minutes of
target to review meetings meetings meetings meetings meetings PR office
held with meeting meetings.
sharing in- perfor- held. held. held. held. held.
stakehold- held.
formation mance and
ers.
with public emerging
on topic issues for
issues. continuous
improve-
ment are
lacking.
Strategic Intervention 3.2: Enhance internal corporate and public relations function.
3.2.1.1 Number of
Develop stake- 80 16 16 16 16 16
corporate Minutes of
holder meetings meetings meetings meetings meetings meetings PR Office
and public meetings.
relations meetings held. held. held. held. held. held.
plan. held.
3.2.1
Strengthen 3.2.1.2
internal Communi- Number
Commu-
commu- cate new of internal 20
nication
nication arrangement commu- engage-
tools
capacity to all internal nications ments 4 4 4 4 4 PR Office
created
to project stakehold- efforts with
and shared
a strong ers using undertak- staff.
with staff.
corporate appropriate en.
image. means.
10000
3.2.1.3. Hold stories
Number of published
corporate on NDA
publica-
and public both in 200 200 200 200 200 Field
tions on main- PR Office
relations stories stories stories stories stories reports
NDA in the stream
media en-
media. media
gagements. and
online.
Strategic Intervention 3.3: Enhance stakeholder collaboration and partnership at national, regional and international level.
3.3.1:
Strengthen 3.3.1.1
the part- Develop
nership plan for stakehold-
strategy stakeholder er collabo-
20 part- 4 part- 4 part- 4 part- 4 part- 4 part-
to harness collabo- Plan devel- ration and
nerships nerships nerships nerships nerships nerships SA Office
synergies ration and oped. part-
and best partnership created. created. created. created. created. created.
nership
practices at national, document.
in drug regional and
131
regulation. international.
[contd...]
132
ANNUAL TARGETS
PARTY
FY
FY
FY
FY
FY
OUTPUT
OUTPUT
ACTIONS
TARGETS
MEANS OF
ACTIVITIES
STRATEGIC
2020/21
2021/22
2022/23
2023/24
2024/25
INDICATORS
VERIFICATION
RESPONSIBLE
10
3.3.1.2
critical
Develop a
partner-
framework
ships
to foster
with key
national and Framework framework
stake- 2 2 2 2 2 SA Office
international developed. doc.
holders
stakeholder
both
engagement
local and
and partner-
interna-
ships.
tional.
3.3.1:
Strengthen 3.3.1.3.
the part- Attend
Number of
nership strategic 60
inter-
strategy meetings/ bench- Meeting
vention 12 visits 12 visits 12 visits 12 visits 12 visits
to harness conferences/ marking reports
bench- conduct- conduct- conduct- conduct- conduct- SA Office
synergies events/ AU/ visits and min-
marking ed. ed. ed. ed. ed.
and best WHO/ EAC conduct- utes.
visits
practices harmo- ed.
conducted.
in drug nization
regulation. meetings.
[contd...]
3.3.1.4 Number of 60 12 meet- 12 meet- 12 meet- 12 meet- 12 meet- Meeting
Stakeholder SA Office
meetings meetings
Manage- ings. ings. ings. ings. ings. minutes.
held. attende.d
ment.
3.3.1.5
Conduct fact
finding and Number of 40
supervisory regional regional 8 region- 8 region- 8 region- 8 region- 8 region- Field
SA Office
visits to the visits car- visits al visits. al visits. al visits. al visits. al visits. reports.
NDA regions ried out. held.
(SA & Direc-
tors).
Reports
Propor- 80 80 80 80 80 shared and
3.3.1.6 80
tion of groups groups groups groups groups recom-
Business groups SA Office
Business
Information met met met met met met mendation
groups
gathering. annually. annually. annually. annually. annually. annually. imple-
met.
mented.
3.3.1.7
Support and Number of
undertake Strate- 300 CSR 21 CSR 21 CSR 86 CSR 86 CSR 86 CSR
CSR activi- gic CSR activities activities activities activities activities activities SA Office
ties to assist support imple-
individuals implemented. funded. funded. funded. funded. funded.
and commu- mented.
nities.
Number
3.3.1.8 of staff
Training for trained 105 staff 21 staff 21 staff 21 staff 21 staff 21 staff Training
SA Office
staff under and train- trained.
133
trained. trained. trained. trained. trained. reports.

SA’s office. ing reports
shared.
ANNUAL TARGETS
134
PARTY
FY
FY
FY
FY
FY
OUTPUT
OUTPUT
ACTIONS
TARGETS
MEANS OF
ACTIVITIES
STRATEGIC
2020/21
2021/22
2022/23
2023/24
2024/25
INDICATORS
VERIFICATION
RESPONSIBLE
Number of 205 41 41 41 41 41 Meeting

3.3.1.9 Authority meetings meetings meetings meetings meetings meetings resolutions
Coordinate meetings,
Commis- coordi- coordi- coordi- coordi- coordi- coordi- shared and
activities sion meet- nated. nated. nated. nated. nated. nated. imple-
of the drug ings and mented.
3.3.1: authority Committee

Strengthen (Authority meetings
coordi-
the part- meet- nated and
nership ings, NDA resolutions Reports
shared 40 8 train- 8 train- 8 train- 8 train- 8 train- and rec-
strategy Commission & imple-
to harness meetings, mented. capacity ings. ings. ings. ings. ings. ommen- SA Office
synergies Committee building dations
and best meetings, trainings imple-
practices capacity Number of & fact mented.
in drug building capacity finding
building missions
regulation. trainings/ trainings/ coordi-
workshops workshops
and fact and fact nated.
finding
finding missions
missions). coordinat-
ed.
Strategic Objective 4: To strengthen NDA institutional capacity to effectively and efficiently implement its functions, (infra-
structure, performance systems, human resource, finance).
Strategic Intervention 4.1 Enhance the NDA infrastructure and facilities for her capacity growth.
4.1.1.1
Completion Complet- Com- Commis- Procure-
and equip- ed/Com- Commis- pletion sioned ment
ping of lab missioned sioned construc- functional Completion Depart-
4.1.1: tower. lab tower. lab tower. tion. lab. certificate. ment.
Completion
and Equip-
ping of the 4.1.1.2 Complet-
Comple- ed/Com- Commis- Com- Commis-
laboratory tion and sioned
tower and equipping missioned micro pletion sioned Completion
microbi- of micro micro biology construc- functional certificate.
ology lab biology lab biology lab. tion. lab.
(Mulago). at Mulago. lab.
Asset
Develop an Asset Asset Manage- Copy of Human
asset man- Man- man- ment stra- asset Man- Resource
agement agement agement tegic plan agement and
strategic strategic strategic developed strategic Adminis-
plan. plan devel- plan de- in line plan devel- tration.
opment. veloped. with GoU oped.
guidelines.
4.1.2.1 Es- Establish

tablishment Teso
of Teso re- regional
gional office Number office.
4.1.2: & acquisition of space 2 Acquire
Offices and SA-DCS
Establish- of land acquired. Land title
Land for
ment / for Hoima Hoima
construc- regional regional
tion of offices. office.
regional
offices.
[contd...] 4.1.2.2.
Tendering Tendering Tender- Procure- Procure-
135
and contract coming & ment doc- ment

award for mence- contract uments. Depart-
2 regional ment. award. ment.
offices.
ANNUAL TARGETS
136
PARTY
FY
FY
FY
FY
FY
OUTPUT
OUTPUT
ACTIONS
TARGETS
MEANS OF
ACTIVITIES
STRATEGIC
2020/21
2021/22
2022/23
2023/24
2024/25
INDICATORS
VERIFICATION
RESPONSIBLE
4.1.2.3. Es-
tablishment/
4.1.2: construc- Construc-
Construc-
Establish- tion of the Number of tion of Completed
tion of Procure-
ment / construction regional greater physical
Hoima ment
construc- works for offices 2 Teso and regional
City Depart-
tion of 2 regional construct- Karamoja offices
regional ment.
regional office for ed. regional existing.
offices.
offices. greater Teso offices.
and Karamo-
ja regions.
Strategic Intervention 4.2: Strengthen and ensure a sustainable management information system through automation and
integration across the organization and other relevant MDAs.
4.2.1.1: Im-
proving the
automated
processes.
a) Pharmacy
licensing
b) import
export
verifica-
tion.
c) Inspection
4.2.1: activities.
automate d) Product 9 auto-
Number of
and inte- registra- mated
automated All sys- All sys- All sys- All sys- All sys-
grated all process- DCS-ICT
tion. processes tems tems tems tems tems
business es im-
e) Products improved.
processes proved.
at NDA. retention
f) GMP ap-
plications.
g) Finance
invoicing
and re-
ceipting.
h) Ports of
entry.
inspection
activities.
i) GDP, GPP
processes.
j) Drug pro-
motion.
137
ANNUAL TARGETS
PARTY
FY
FY
FY
FY
FY
OUTPUT
OUTPUT
138
ACTIONS
TARGETS
MEANS OF
ACTIVITIES
STRATEGIC
2020/21
2021/22
2022/23
2023/24
2024/25
INDICATORS
VERIFICATION
RESPONSIBLE
4.2.1.2:
Automate
the following
business
processes;
a) Clinical
trials.
b) QMS
c) Product
compliant
handling.
d) Recall
handlings
e) Lab (LIMS
document
control).
f) Drug shop - Recall
licensing. han-
4.2.2: g) Planning dling.
Secure ICT h) and M&E - Enforce-
Risk man-
infrastruc- agement ment
ture across system. activi-
the orga- i) Pharma- ties.
covigi-
nization. lance - Procure-
[contd...] j) Geo-map- ment
ping for plan Pharma-
licensed covigi-
outlets. perfor-
k) Procure- mance lance.
ment man-
system. a) Clinical a) Plan- a) Drug Registry
l) HR, Number of trials ning and shop age-
m) Registry processes 21 pro- M&E. licens- ment Track and
n) Track and automated. cesses. b) QMS ing. system. trace.
trace
o) Enforce- c) Product b) Pro- b) Geo- - Addi- Enforce-
ment curement map- tional ment DCS-ICT
activities com- LIMS
system. ping for activities.
p) Internal pliant
audit licensed mod-
system. hand- c) HR, outlets. ules Internal
q) Commu- ling (equip- audit
nication d) Lab d) Track c) Risk ment system.
channel and trace. man-
system. (LIMS) mainte-
r) Post mar- age- nance Commu-
ket sur- ment and nication
veillance system. channel
system. cali-
bration, system.
s) Procure-
ment plan envi-
perfor- ron-
mance
man- mental
agement moni-
system. toring,
t) Additional
LIMS lab
modules QMS).
(equip- - Integra-
ment
mainte- tion of
nance and chro-
calibra- mato-
tion, envi- graphic
ronmental
monitor- systems.
ing, lab - Opera-
QMS). tional
u) Integra-
tion of Re-
chromato- search
graphic man-
systems.
v) Oper- age-
ment
139
ational
Research system.
man-
agement
system.
ANNUAL TARGETS
140
PARTY
FY
FY
FY
FY
FY
OUTPUT
OUTPUT
ACTIONS
TARGETS
MEANS OF
ACTIVITIES
STRATEGIC
2020/21
2021/22
2022/23
2023/24
2024/25
INDICATORS
VERIFICATION
RESPONSIBLE
4.2.1.3: DCS-ICT
Integrate
Number of
NDAMIS 2 sys- 2 sys- 2 sys-
MDA ICT 2 1 system
with other
systems 9 sys- systems tems tems tems

relevant (MoH-
integrat- tems. (URA & (NMS (URSB & (MAAIF &
e-govern- HMIS).
ed with Bank). &PPDA). NITA-U). MoT).
ment sys-
NDAMIS.
tems used in
MDAs.
4.2.2.1: Number of 5 ICT

1 ICT 1 ICT 1 ICT 1 ICT 1 ICT
Update ICT updated continu-
continuity continuity continuity continuity continuity DCS-ICT
continuity ICT conti- ity plans
plan. plan. plan. plan. plan.
plan. nuity plan. updates.
20 pre- 4 pre- 4 pre- 4 pre- 4 pre-

4.2.2: 4.2.2.2: Number of 4 preven-
ventive ventive ventive ventive ventive
Secure ICT Carry out preventive tive main-
mainte- mainte- mainte- mainte- mainte-
infrastruc- preventive mainte- tenance
ture across nance nance nance nance nance DCS-ICT
maintenance nance session
the organi- session session session session session
of the ICT session conduct-
zation. conduct- conduct- conduct- conduct- conduct-
systems. conducted. ed.
ed. ed. ed. ed. ed.
4.2.2.3:
Proportion 90% of 90% of 90% of 90% of 90% of 90% of
Provide ICT
of ICT user ICT user ICT user ICT user ICT user ICT user ICT user
support DCS-ICT
request request request request request request request
across the
resolved. resolved. resolved. resolved. resolved. resolved. resolved.
organization.
4.2.2.4:
Proportion 100%
Acquire ICT
of ICT ICT infra-
infrastruc-
infrastruc- structure 100% 100% 100% 100% 100%
ture (serv- DCS-ICT
ture needs needs met. met. met. met. met.
ers/firewall
request request
core routers/
met. met.
switches.
4.2.2.5:
Proportion 100% 100% 100% 100% 100% 100%
Maintain
of ICT ICT ICT ICT ICT ICT ICT
the network DCS-ICT
network network network network network network network
security of
secured. secured. secured. secured. secured. secured. secured.
NDA.
Strategic Intervention 4.3: Strengthen Corporate Governance practices and Human Resource capacity.
4.3.1
Harness Number of
4.3.1.1 Reso-
the Drug perfor-
Conduct 10 per- lutions
Authority mance
Authority formance 2 2 2 2 2 shared and Authority
over- review
performance reviews. imple-
sight and meetings
reviews. mented.
operation. held.
[contd...]
141
ANNUAL TARGETS
142
PARTY
FY
FY
FY
FY
FY
OUTPUT
OUTPUT
ACTIONS
TARGETS
MEANS OF
ACTIVITIES
STRATEGIC
2020/21
2021/22
2022/23
2023/24
2024/25
INDICATORS
VERIFICATION
RESPONSIBLE
Number of Reso-
Authority 30 meet- lutions
6 6 6 6 6 shared and Authority
Meetings ings.
imple-
held. mented.
4.3.1.2
Conduct Number of Reso-
meetings Com- lutions
15 meet-
of the drug mission 3 3 3 3 3 shared and Authority
ings.
authority and Meetings imple-
committees. held. mented.
Reso-
Number of lutions
Committee 160 4 4 4 4 4 shared and Authority
meetings meetings. imple-
4.3.1 held. mented.
Harness
the Drug Number of
Authority 4.3.1.3 Hold Capacity 40 Reports
8 8 8 8 8
oversight Capacity building capacity shared and
trainings trainings trainings trainings trainings
and opera- building and and fact building recom-
and fact and fact and fact and fact and fact
tion. fact finding finding training men- Authority
finding finding finding finding finding
activities for activities and fact dations
mission mission mission mission mission
members of for mem- finding imple-
activities. activities. activities. activities. activities.
the Authority. bers of the reports. mented.
Authority.
Reports
4.3.1.4 Hold Number of 10
shared and
Benchmark- Authority bench-
recom-
ing activities bench- marking
2 2 2 2 2 men- Authority
for members marking visits
dations
of the drug visits im- carried
imple-
Authority. plemented. out.
mented.
4.3.2:1 Re- 100% 100% 100% 100% 100% 100%

view man- Right staffing staffing staffing staffing staffing staffing
power plan staffing achieved achieved achieved achieved achieved achieved Workload
and staff numbers and and and and and and audit
develop- and staff 100% 100% 100% 100% 100% 100% report, Dept
4.3.2: ment needs devel- staff staff staff staff staff staff training HRA
periodically opment devel- devel- devel- devel- devel- devel- needs
Enhance to align with opment opment analysis
institution- regulatory needs opment opment needs opment opment needs report,
needs of the identified . needs needs identi- needs needs identi-
al devel- identified. identified. identified. identified.
opment time. fied . fied .
through
regular 4.3.2:2
reviews Conduct
work load Staff Total
and human analysis to workload
capital de- align human analysed workload Workload Dept
to inform analysis audit HRA
velopment resource conduct- report.
in line with capacity staffing ed.
the human with work needs.
responsibil-
rights ities.
[contd...]
4.3.2:3 Staff de-
Provide for velopment Training Dept
staff training interven- reports . HRA
143
and develop- tions im-
ment. plemented.
ANNUAL TARGETS
144
PARTY
FY
FY
FY
FY
FY
OUTPUT
OUTPUT
ACTIONS
TARGETS
MEANS OF
ACTIVITIES
STRATEGIC
2020/21
2021/22
2022/23
2023/24
2024/25
INDICATORS
VERIFICATION
RESPONSIBLE
Staff pro-
fessional
member- 100% 100% 100% 100% 100% 100%
4.3.2:4 Fa- ship paid enroll- enroll- enroll- enroll- enroll- enroll-
cilitate staff and staff ment into ment into ment into ment into ment into ment into Payment Dept
professional registered the pro- the pro- the pro- the pro- the pro- the pro- receipts. HRA
membership. with their fessional fessional fessional fessional fessional fessional
respective bodies. bodies. bodies. bodies. bodies. bodies.
4.3.2: profession-
Enhance al bodies.
institution-
4.3.2:5 Con- All All All All All All Copies of
al devel- adverts,
opment duct staff approved approved approved approved approved approved interview
through recruitment Staff vacant vacant vacant vacant vacant vacant reports, Dept
in line with recruited. positions positions positions positions positions positions offer HRA
regular the human filled filled filled filled filled filled
reviews rights. (100%). (100%). (100%). (100%). (100%). (100%). letters and
contracts.
and human
capital de-
4.3.2:6 Perfor-
velopment Perfor- Perfor- mance
in line with Carryout mance mance All staff All staff All staff All staff All staff man-
the human Performance man- man- undergo undergo undergo undergo undergo agement
manage- agement agement perfor- perfor- perfor- perfor- perfor- policy, per- Dept
rights. ment while mance mance mance mance mance HRA
complying policy and plans apprais- apprais- apprais- apprais- apprais- formance
with the hu- plan in imple- als . als. als. als. als. appraisals
man rights. place. mented. and
reports.
4.3.2:7 Suc- Up to Up to Up to Up to Up to Succession
Succession Succession cession date Suc- date Suc- date Suc- date Suc- date Suc- planning
planning planning planning cession cession cession cession cession policy Dept
while policy and plan planning planning planning planning planning document HRA
observing plan devel- imple- dash- dash- dash- dash- dash- & dash-
human oped. mented. board. board. board. board. board. board.
rights.
4.3.2:8 Annual Annual Annual Annual Annual

Occupational Occu- Occu- occu- occu- occu- occu- occu-
health and pational pational pational pational pational pational pational Occu-
safety man- health health health health health health health pational Dept
agement and safety and safe- and and and and and health HRA
in line with policy and ty plan safety safety safety safety safety and safety
the human plan devel- imple- budget & budget & budget & budget & budget & reports.
rights. oped. mented. interven- interven- interven- interven- interven-
tions. tions. tions. tions. tions.
Employee Annual Annual Annual Annual Annual Annual Employee

4.3.2:9 Im- rela- employee employee employee employee employee employee rela-
plementation tionship relation- relation- relation- relation- relation- relation- tionship Dept
of employee policies
budget ships ships ships ships ships ships activity HRA
relationships and
developed activities activities activities activities activities activities implemen-
activities. and imple- imple- imple- imple- imple- imple- imple- tation
mented. mented. mented. mented. mented. mented. mented. reports.
Asset
4.3.3.1 Con- NDA’s All NDA All NDA All NDA All NDA All NDA All NDA mainte-
4.3.3: En- duct mainte- estates estates estates estates estates estates estates nance Dept
nance of the main- main- main- main- main- main- main- reports, HRA
hance an estates. tained. tained. tained. tained. tained. tained. tained. receipts
effective etc
admin-
istration 4.3.3.2 Right fleet All staff Fleet/
system. Provide procured requests 100% 100% 100% 100% 100% vehicle
and main- for staff staff staff staff staff allocation Dept
145
[contd...] transport for tained in a transport requests requests requests requests requests schedules
staff move- HRA
ment. motorable honored honored. honored. honored. honored. honored. and trip
condition. 100%. reports.
ANNUAL TARGETS
146
PARTY
FY
FY
FY
FY
FY
OUTPUT
OUTPUT
ACTIONS
TARGETS
MEANS OF
ACTIVITIES
STRATEGIC
2020/21
2021/22
2022/23
2023/24
2024/25
INDICATORS
VERIFICATION
RESPONSIBLE
Office All
4.3.3.3 equipment martials
Provide procured required All All All All All
Dept
materials and main- for office martials martials martials martials martials Receipts HRA
for office tained in a oper- procured. procured. procured. procured. procured.
operations. functional ations
state. procured.
Corporate 100%
4.3.3.4 wear of staff Payment
Provide cor- purchased provided 100% of 100% of 100% of 100% of 100% of Receipts Dept
porate wear and dis- with staff. staff. staff. staff. staff. and distri- HRA
for staff. tributed to corporate bution list.
staff. wear.
4.3.3: En-
hance an 100%
effective Insurance
4.3.3.5 All staff of staff 100% 100% 100% 100% contracts
admin- Provide enrolled on enrolled 100% Dept
of staff of staff of staff of staff of staff and
istration insurance for insurance on the HRA
enrolled. enrolled. enrolled. enrolled. payment
system. staff. scheme. insurance enrolled. receipts.
scheme.
Insurance
4.3.3.6 100%
All NDA contracts
Insure the of NDA 100% of 100% of 100% of 100% of 100% of Dept
and
assets of the assets assets assets assets assets assets assets HRA
payment
organization. insured. insured. receipts.
Contracts
100%
for the
4.3.3.7 Pro- Staff pro- of staff
100% of 100% of 100% of 100% of 100% of supply of Dept
vide meals vided with provided
staff staff staff staff staff meals and HRA
for staff. meals. with
payment
meals.
receipts.
Staff 100%
emolu- of staff
4.3.3.8 Pay
ments paid provided 100% of 100% of 100% of 100% of 100% of Copy of the Dept
staff emolu-
according with their staff staff staff staff staff Payroll. HRA
ments.
to the emolu-
policy. ments.
100%
All fleet
P4.3.3.9 of fleet
provid-
provide fuel provided 100% 100% 100% 100% 100% Fuel
ed with Dept
for vehicles with fuel of fleet of fleet of fleet of fleet of fleet loading
fuel on a HRA
and motor on a provided. provided. provided. provided. provided reports.
monthly
cycles. monthly
basis.
basis.
100%
4.3.3.10 NDA fleet NDA fleet
Maintenance main- main- 100% 100% 100% 100% 100% Vehicle
Dept
of cars tained in a tained main- main- main- main- main- service
HRA
and motor motorable in a mo- tained. tained. tained. tained. tained. reports .
cycles. state. torable
state.
147
ANNUAL TARGETS
148
PARTY
FY
FY
FY
FY
FY
OUTPUT
OUTPUT
ACTIONS
TARGETS
MEANS OF
ACTIVITIES
STRATEGIC
2020/21
2021/22
2022/23
2023/24
2024/25
INDICATORS
VERIFICATION
RESPONSIBLE
Number
4.3.4.1 Pre- 56 inter- Internal
of internal
pare internal nal audit Audit audit
audit 10 11 11 12 12
audit reports reports reports. depart-

reports
prepared. prepared. ment.
prepared.
4.3.4.2
Follow-up
audits on Conduct
implemen- Internal
Number of follow-up
tation of Audit audit
audit on 5 5 6 6 6
internal and follow-up reports. depart-
audits. 28 audit
external ment.
reports.
audit recom-
mendations
conducted.
4.3.4.3 Con- Number Internal

duct special of special Audit audit
audits con- audits con- 1 1 1 1 1
4.3.4: reports. depart-
ducted as ducted as
Strengthen requested. ment.
requested.
internal
Audit Internal
oversight. 4.3.4.4 Number of 4 audits ICT Audit audit
Conduct ICT ICT audits conduct- 1 1 1 1 reports. depart-
audits. conducted. ed. ment.
Number of Conduct
4.3.4.5 Internal
stake- 5 stake- Minutes
Stakehold- audit
holders holder’s 1 1 1 1 1 and
er’s engage- depart-
engage- engage- reports.
ments. ment.
ments. ments.
Number Provide
4.3.4.6 Audit
of Audit at least 3 Internal
advisory
advisory audit ad- audit
services are 3 5 6 7 7 Reports
services visory to depart-
offered from
are of- Manage- ment.
time to time.
fered. ment.
4.3.5: Proportion
4.3.5.1 Con- Service
Establish of SDT’s
duct reviews delivery
mech- imple-
and update timeline
anisms mented 89% 80% 80% 82% 84% 86% SA
of the ser- perfor-
for timely within the
vice delivery mance
service agreed
timelines. reports.
delivery. timeline.
Strategic Intervention 4.4: Enhance the Institutional resource mobilization capacity and sustainability.
4.4.1
Strengthen
mecha- Resource
nisms for 4.4.1.1. Resource mobili- Resource
resource Develop a mobilization mobili-
resource zation strategy zation Finance
mobiliza- mobilization strategy
tion and strategy. developed. devel- strategy.
oped.
149
sustain-
ability
[contd...]
150
FY
FY
FY
FY
FY
OUTPUT
OUTPUT
ACTIONS
TARGETS
MEANS OF
ACTIVITIES
STRATEGIC
2020/21
2021/22
2022/23
2023/24
2024/25
INDICATORS
VERIFICATION
RESPONSIBLE
A resource 1 Re-
4.4.1.2. mobili- source com-
Constitute zation mobiliza- mittee
a resource committee tion com- constitut-

mobilization constitut- mittee ed.
committee. ed. constitut-
ed.
4.4.1.3.
conduct Number of
resource meetings 16 4 4 4 4
mobilization held. meetings
committee Quarterly.
meetings.
4.4.1.4. Number of 12 Col-

Collaboration Collab- labora-
4.4.1 and bench tion and
Strengthen marking oration bench
visits for and bench marking 4 4 2 2
mecha- marking
nisms for improved visits con- visits
resource ducted. conduct-
resource mobilization. ed.
mobiliza-
tion and 4.4.1.5.
sustain- Conduct a Gap anal- Gap Gap
ability gap analysis ysis report analysis analysis
[contd...] (across developed. report. report.
resource and
skills gaps).
4.4.1.6. Number of 16
Capacity capacity capacity 4 work- 4 work- 4 work- Training
building in building building shops. shops. shops. reports
resource workshops work-
mobilization. held. shops.
4.4.1.7.
Identify
funding Number 12 alter-
sources of funding native 3 alter- 3 alter- 3 alter- 3 alter- alternative
categories sources of resourc- native re- native re- native re- native re- resources
for diversi- revenue es of sources sources sources sources of revenue
fication and identified. revenue identified. identified. identified. identified. identified.
widening of identified.
the resource
base.
4.4.1.8.
Develop
proposals to Number 32 RFAs 8 RFAs 8 RFAs 8 RFAs 8 RFAs
respond to of RFAs submit- submit- submit- submit- submit-
request for submitted. ted. ted. ted. ted. ted.
applications
(RFA).
4.4.1.9.
Direct 16
development Number of proposals 4 submit- 4 submit- 4 submit- 4 submit-
partner proposals submitted. ted. ted. ted.
engagement submitted. ted.
(Private &
non private).
4.4.1.10. Proportion 100%

Compliance of compli- compli- 100% 100% 100% 100%
151
reporting to ance. ance.

donors.
ANNUAL TARGETS
152
PARTY
FY
FY
FY
FY
FY
OUTPUT
OUTPUT
ACTIONS
TARGETS
MEANS OF
ACTIVITIES
STRATEGIC
2020/21
2021/22
2022/23
2023/24
2024/25
INDICATORS
VERIFICATION
RESPONSIBLE
4.4.1.11.
Conduct
annual Number 4 of
reviews/ of reviews reviews 1 1 1 1

meetings of conducted. conduct-
the resource ed.
mobilization
plan.
4.4.1.12.
Strengthen Financial
the financial reports. Finance
management
system.
4.4.1.13. Budget By 31st Budget Budget Budget Budget Budget

Co-ordinate approved January approved approved approved approved approved Reviewed
st st st st
the annual by the every 31 31 31 31 31st Budget. Finance
4.4.1 budgeting Authority. Financial January January January January January
Strengthen process. year. every. every. every. every. every.
mecha-
nisms for 4.4.1.14.
resource Implement Budget
stringent Perfor-
mobiliza- Financial
tion and internal con- mance 20 4 4 4 4 4 Reports Finance
trol systems reports
sustain- presented.
ability. to ensure
compliance.
4.4.1.15. Number of
Visits to re- recom-
gional offic- men- Field
es to ensure dations 8 1 1 2 2 2 reports. Finance
compliance imple-
to Financial mented.
controls.
Budget Budget Budget Budget Budget

4.4.1.16. Reviewed By 25th reconcil- reconcil- reconcil- reconcil- reconcil-
Maintain ac- bank day iation by iation by iation by iation by iation by Bank rec-
curate bank reconcilia- of the 25th day 25th day 25th day 25th day 25th day onciliation Finance
and financial tions. month of the of the of the of the of the reports.
records. following. month month month month month
following. following. following. following. following.
4.4.1.17.
Licensing/
support Reviews 5 1 1 1 1 1 Report Finance
and system conducted.
integrity
reviews.
Number of
Statutory Financial Financial Financial Financial Financial
4.4.1.18. financial 5 accounts accounts accounts accounts accounts
Co-ordinate reports statutory produced produced produced produced produced
and plan for produced financial by 31st by 31st by 31st by 31st by 31st Reports Finance
statutory by 31st accounts August August August August August
audits. August complet- of every of every of every of every of every
of every ed. financial financial financial financial financial
financial year. year. year. year. year.
year.
5 annual Audited Audited Audited Audited Audited Audited
153
4.4.1.19. statutory Accounts Accounts Accounts Accounts Accounts Accounts Audited

Co-ordinate audits shared shared shared shared shared shared Accounts Finance
OAG audits. 31st
completed. byDec. by 31st by 31st by 31st by 31st by 31st
Dec. Dec. Dec. Dec. Dec.
ANNUAL TARGETS
154
PARTY
FY
FY
FY
FY
FY
OUTPUT
OUTPUT
ACTIONS
TARGETS
MEANS OF
ACTIVITIES
STRATEGIC
2020/21
2021/22
2022/23
2023/24
2024/25
INDICATORS
VERIFICATION
RESPONSIBLE
4.4.2.1. Hold Number of

a stakehold- stake- 5 work-
er workshop holder shops 1 1 1 1 1 Workshop SA-DPC
on regulato- workshops conduct- reports.

ry self-fi- conducted. ed.
nancing.
4.4.2.2.
Identify NDA Number of 4 alter-
resources alternative native
for diversi- resources resourc- 1 1 1 1 Workshop SA-DPC
4.4.2: fication and es of reports.
Promote widening of of revenue revenue
regulatory the resource identified. identified.
self-fi- base.
nancing.
4.4.2.3.
Implement
resource 3 of al-
mobilization Number of 1 of al- 2 of al-
plan for the alternative ternative ternative ternative
identified resources resourc- resourc- resourc- Workshop SA-DPC
NDA revenue of revenue es of es of es of reports
revenue revenue revenue
generation created. created. created. created.
resources
(Lab, office
tower).
Strategic Intervention 4.5: Strengthen the corporate planning and programme performance management systems.
Strategic Quarterly,
Strategic mid-term
4.5.1De- Plan FY plan FY
velop the Strategic 2026- and end of DCS-
strategic Plan devel- 2026-
2031 term per-
plan 2026- oped. 2031 formance BPD
2031. devel- devel-
oped. review
oped. reports.
Number of
4.5.2 Director- 8 regions 8 regions
ates and 8 regions
Training of and 5 and 5 and 5
Directorate regional
offices Direc- Direc- Direc- Training
staff in DCS-
planning and trained in torates torates torates evaluation
4.5.1 planning and SA’s reports. BPD
and SA’s and SA’s
Strengthen programme
develop- and pro- office
gramme office office
planning ment. trained.
develop- trained. trained.
and pro- ment.
gramme
man- Number
4.5.3. Train- of staff
agement trained
ing MBPD in in public
imple- Public Policy Training
mentation. Planning, policy, 1 staff DCS-
Analysis, planning, trained. report
[contd...] analysis, BPD
Formulation shared.
and Man- formula-
agement. tion and
manage-
ment.
4.5.4. Number of
coordi- Meeting
Coordinate nation Minutes
the devel- meetings
opment of 1 meet- 1 meet- 1 meet- for pro- DCS-
performance for pro- 3 meet- gramme
gramme ings ing held. ing held. ing held. BPD
155
improvement develop- develop-

programmes ment and ment and
across the implemen-
organization. training.
tation.
ANNUAL TARGETS
156
PARTY
FY
FY
FY
FY
FY
OUTPUT
OUTPUT
ACTIONS
TARGETS
MEANS OF
ACTIVITIES
STRATEGIC
2020/21
2021/22
2022/23
2023/24
2024/25
INDICATORS
VERIFICATION
RESPONSIBLE
4.5.5
Coordinate 5 five
Number of One (1) One (1) One (1) One (1) One (1) Approved
work plan work DCS-
work plans Work Work Work Work Work work
development plans de- BPD
developed. Plan. Plan. Plan. Plan. Plan. plans.
with all Di- veloped.
rectorates.
4.5.6 Carry-
out bench-
4.5.1 marking on
Bench-
Strengthen performance marking
planning management Number of Bench- Bench- Bench- Bench- Bench-
report and
and pro- systems in; bench- marking marking marking marking marking DCS-
5 imple-
gramme planning, marking report report report report report BPD
mentation
man- risk man- conducted shared. shared. shared. shared. shared.
action
agement agement and
reports.
implemen- monitoring
tation. and evalua-
tion.
Number of
4.5.7. Coor- 36 12 12 12
monthly
dinate the project project project project Project
Project
implemen- man- man- man- man- man- DCS-
Man-
tation of the agement agement agement agement agement BPD
agement
Laboratory reports reports reports reports reports.
reports
Tower. shared. shared. shared. shared.
shared.
4.5.2.1.
Engage the
consultant to
train man-
agement
and staff in Number
Enterprise staff 50staff 50 staff 50 staff DCS-
risk man- trained in trained. trained. trained. BPD
agement and ERM.
integration
including
initiating the
procurement
for venue.
4.5.2
Strengthen Number
risk man- of risk Five (5)
agement 4.5.2.2. Up- registers Approved Approved Approved Approved Approved Approved Audit DCS-
system date the risk risk risk risk risk risk
register. updated risk report. BPD
[contd...] register. register. register. register. register.
and ap- register.
proved.
4.5.2.3.
Develop and Business Monitor- Monitor- Monitor-
implement Business 1 Continu- ing re- ing re- ing re-
a Business BCP Per-
Continuity business ity Man- ports for ports for ports for
Continu- formance DCS-
ity(crisis Manage- continuity agement business business business
monitoring BPD
management Plan plan de- Plan continu- continu- continu-
reports.
ment) developed. veloped. devel- ity resil- ity resil- ity resil-
Management oped. ience. ience. ience.
plan.
4.5.2.4. Number of Five (5)

Develop approved approved approved approved approved Approved
approved approved DCS-
risk risk risk risk risk risk
157
the Risk risk risk

Treatment treatment treatment treatment treatment treatment treatment BPD
plan for all treatment treatment plan. plan. plan. plan. plan. plans.
directorates. plans. plan.
ANNUAL TARGETS
158
PARTY
FY
FY
FY
FY
FY
OUTPUT
OUTPUT
ACTIONS
TARGETS
MEANS OF
ACTIVITIES
STRATEGIC
2020/21
2021/22
2022/23
2023/24
2024/25
INDICATORS
VERIFICATION
RESPONSIBLE
4.5.2.5. Con-
Number of
duct routine
quarterly 15 risk 3 risk 4 risk 4 risk 4 risk
risk moni-
perfor- perfor- perfor- perfor- perfor- perfor- Risk per-
toring and
mance mance mance mance mance mance formance DCS-
evaluation of
reports on moni- moni- moni- moni- moni- monitoring BPD
implement-
risk treat- toring toring toring toring toring reports.
ing the risk
ment and reports. report. report. report. report.
treatment
evaluation.
plan.
Number
4.5.2.6. Up- 2 Updat- Approved Approved Approved
of risk DCS-
date the risk ed risk Risk Risk risk strate-
strategies BPD
strategy. strategy. strategy. strategy. gies.
updated.
4.5.2 4.5.2.7. 2 devel- Approved

Number of
Strengthen Develop and oped DRP disaster
the DRP Perfor- Perfor-
risk man- monitory 2 perfor- recovery
1 de- mance mance
agement the imple- mance 1 devel- plan DCS-
Number veloped monitor- monitor-
system mentation moni- oped DRP DRP per- BPD
of DRP DRP. ing report ing report
[contd...] of a disaster toring formance
monitoring on DRP. on DRP.
recovery reports monitoring
reports.
plan. for DRP. report.
2 risk
appetite
state- Approved Approved
4.5.2.8. Number ment Risk Risk
Develop and of risk reports appetite appetite
DCS-
review the appetite devel- state- state-
BPD
Risk appetite statement oped for ment ment
statement. developed. approval 2021- 2026-
by the 2025. 2031.
Drug
Authority.
Number of
Coordina-
4.5.2.9. quarterly
tion perfor-
Coordinate perfor-
mance
the performance co- 15 coor- 3 coor- 4 coor- 4 coor- 4 coor-
reports DCS-
mance risk ordination dination dination dination dination dination
coming BPD
monitoring reports meetings. meetings. meetings. meetings. meetings.
from risk
of the risk from risk
champi-
champions. champi-
ons.
ons.
E-risk
man-
agement
4.5.2.10. Risk Imple- Imple-
Estab- system
Procure and man- ment an ment an
lished automat-
establish agement automat- automat- DCS-
automated ed.
automated process ed Risk ed Risk
risk man- BPD
risk man- automat- man- man-
agement Imple-
agement ed and agement agement
system. men-
system. piloted. process. process.
159
tation
report
shared.
160
FY
FY
FY
FY
FY
OUTPUT
OUTPUT
ACTIONS
TARGETS
MEANS OF
ACTIVITIES
STRATEGIC
2020/21
2021/22
2022/23
2023/24
2024/25
INDICATORS
VERIFICATION
RESPONSIBLE
4.5.2.11.
4.5.2 Conduct En- Five (5) Two (2)
1 ERM 1 ERM 1 ERM Training
Strengthen terprise Risk No. of ERM ERM

trainings trainings trainings reports on DCS-
risk man- Manage- trainings trainings trainings
conduct- conduct- conduct- Risk Man- BPD
agement ment (ERM) conducted. conduct- conduct-
ed. ed. ed. agement.
system. awareness ed. ed.
training.
Approved Approved
M&E M&E
4.5.3.1 Plan with Plan with
Number of 2 M&E
develop and indica- indica- Approved DCS-
M&E plan plans de-
update the tors and tors and M&E plan. BPD
developed. veloped.
M&E plan. targets. targets.
2021- 2026-
2025. 2031.
Twenty
4.5.3.2 (20)
Quarterly
Carryout Monitor- Four (4) Four (4) Four (4) Four (4) Four (4)
Number of
Performance ing and Quarterly Quarterly Quarterly Quarterly Quarterly Monitoring DCS-
monitoring Evalua-
Monitoring M&E M&E M&E M&E M&E reports. BPD
reports. tion Per-
and evalua- reports. reports. reports. reports. reports.
tion. formance
reports
shared.
4.5.3.3.
Mid-term
conduct Mid-term Mid-term
4.5.3 Strategic
Mid-term Strate- Mid-term Strate-
Strength- plan DCS-
evaluation of gic plan review gic plan
en M&E review BPD
the strategic review Report. review
system conduct-
plan 2020- conducted. report.
[contd...] ed.
2025.
4.5.3.4. End- End-term End-term

End of End of
term review review the Strate-
term term DCS-
the strategic strategic gic plan
review review BPD
plan 2020- plan con- review
Report. Report.
2025. ducted. report.
Operation-
4.5.3.5.
Web- al Web-
Implement Utilization Roll out Roll out Roll out
100% based based
M&E web- rate of a of Web- of Web- of Web- DCS-
utilization DBMS DBMS and
based data web-based based based based BPD
rate. estab- perfor-
management DBMS. DBMS . DBMS. DBMS.
lished. mance
system.
reports.
Five (5)
Annual Annual Annual Annual Annual
Annual
4.5.3.6. Con- M&E M&E M&E M&E M&E
Number of M&E
duct Data reports reports reports reports reports
Quarter- reports DQA DCS-
Validation or incor- incor- incor- incor- incor-
ly DQA incor- reports BPD
Data Quality porated porated porated porated porated
reports. porated
Assessment. with DQA with DQA with DQA with DQA with DQA
with DQA
findings. findings. findings. findings. findings.
findings.
161
ANNUAL TARGETS
162
PARTY
FY
FY
FY
FY
FY
OUTPUT
OUTPUT
ACTIONS
TARGETS
MEANS OF
ACTIVITIES
STRATEGIC
2020/21
2021/22
2022/23
2023/24
2024/25
INDICATORS
VERIFICATION
RESPONSIBLE
4.5.3.7.
Twenty
Preparation
(20)
of Quarterly
Quarterly
activity No. of
Monitor- Four (4) Four (4) Four (4) Four (4) Four (4)
and M&E quarterly Perfor-
ing and Quarterly Quarterly Quarterly Quarterly Quarterly DCS-
performance reports mance
Evalua- M&E M&E M&E M&E M&E BPD
Reports for shared. reports.
tion Per- reports. reports. reports. reports. reports.
Programme
formance
heads, Drug
reports
Authority
shared.
and MoH .
One (1)
4.5.3
M&E
Strength-
Train-
en M&E Seven Three Three
ing for
system 4.5.3.8. Number (7) M&E (3) M&E (3) M&E M&E Train-
process
Conduct of M&E training training training ing Min- DCS-
owners
staff training trainings conduct- conduct- conduct- utes and BPD
and Man-
in M&E. conducted. ed in the ed in the ed in the reports.
agement
regions. regions. regions.
at the
Secretar-
iat .
Strategic Intervention 4.6: Strengthen the Quality Management Systems across the organization.
05 QMS ,
Leader-
Courses
ship and • Certifi-
in QMS,
4.6.1.1 corporate cates of
Initiate train- Leader- gover- training
ing in quality ship and nance 01 01 01 01 01 • Training SA-QMS
manage- corporate reports
courses
ment system gover- initiated • Training
as per ISO nance register
9001:2015 for the
initiated.
standard Drug
and other Authority.
relevant
4.6.1 standards • Certifi-
Strengthen for the Drug Courses cates of
the Quality Authority 10 training
and staff. in QMS
Manage- courses 02 02 02 02 02 • Training SA-QMS
initiated reports
ment for staff.
for staff. • Training
Systems
register
[contd...]
4.6.1.2:
Co-ordinate
the writing, Number of
reviewing, guidelines
checking, No. of coordi-
and autho- 25 nated for
guidelines
rization of Guide- 05 05 05 05 05 review, SA-QMS
controlled reviewed / checking,
lines
documents revised. approval &
and any authoriza-
163
required tion.
change
control:
ANNUAL TARGETS
164
PARTY
FY
FY
FY
FY
FY
OUTPUT
OUTPUT
ACTIONS
TARGETS
MEANS OF
ACTIVITIES
STRATEGIC
2020/21
2021/22
2022/23
2023/24
2024/25
INDICATORS
VERIFICATION
RESPONSIBLE
Number of
Number of manuals
manuals coordi-
and other nated for
05 man-
policy 01 01 01 01 01 review, SA-QMS
uals checking,
documents
reviewed / approval
revised. and autho-
rization.
4.6.1.2:
Co-ordinate Number
the writing, of SOPs, Number of
4.6.1 reviewing, Checklist, SOPs co-
Strengthen checking, TORs & ordinated
the Quality and autho- corre- 50 SOPs 10 10 10 10 10 for review, SA-QMS
Manage- checking,
rization of sponding approval
ment controlled Forms
Systems and autho-
documents reviewed / rization.
[contd...] and any revised.
required
change Number of
control: SIPOCs co-
ordinated
for review,
SIPOCs checking,
25 approval
reviewed / 05 05 05 05 05 and autho- SA-QMS
SIPOCs
revised. rization.
4.6.1.3:
Stakeholder
20 Stakehold-
consultation
Stakehold- Stake- er con-
of new and/
er consul- holder 04 04 04 04 04 sultation SA-QMS
revised
tations. consulta- meeting
guidelines
tions. minutes.
and manu-
als.
4.6.1.4:
Document Documents
expert reviewed Documents
review & and edited 30 06 06 06 06 06 review SA-QMS
editorial by external reports.
services. experts.
4.6.1.5:
Designing
and Printing
of controlled
documents
(Strate- Number of
gic plan, controlled
Manuals, documents
Designed
log books, designed
30 06 06 06 06 06 and Print- SA-QMS
complaint and print-
booklets, ed copies.
ed.
registers,
Quality Poli-
cy pull-ups,
mission and
165
vision pull-
ups and ADR
forms etc).
ANNUAL TARGETS
166
PARTY
FY
FY
FY
FY
FY
OUTPUT
OUTPUT
ACTIONS
TARGETS
MEANS OF
ACTIVITIES
STRATEGIC
2020/21
2021/22
2022/23
2023/24
2024/25
INDICATORS
VERIFICATION
RESPONSIBLE
4.6.1.6:
Consultant Perfor-
to conduct mance Authority
performance evaluation 05 01 01 01 01 01 evaluation SA-QMS
evaluation of of the Drug report.
the Drug Au- Authority.

thority and its
committees.
4.6.1.7: QMS Audit

Initiate quality QMS Audits 20 04 04 04 04 04 reports. SA-QMS
audits in the conducted.
entire NDA.
• Man-
agement
4.6.1.8: Review
Management Man- report
Review Tier agement 10 02 02 02 02 02 • Dash- SA-QMS
1 and Tier Review board for
2 held and meeting. actions
reports made. for
improve-
ment.
4.6.1 02 Re-Cer- ISO 9001

Strengthen tification 02 01 01 Certificate. SA-QMS
the Quality 4.6.1.9: audits.
ISO 9001:
Manage- Surveillance
ment audit coor- 03 cer-
Systems. dinated and tification 03 01 01 01 ISO 9001 SA-QMS
NDA. surveillance Certificate.
audits.
4.6.1.10: External/
External/Inter- Internal Customer
nal Customer Customer satisfaction
05 01 01 01 01 01 SA-QMS
satisfaction satisfaction survey
survey coordi- survey reports.
nated. reports.
Service-re-
lated Com-
4.6.1.11: complaints/ plaints/
Com- Com- Com- Com- Com-
Handle ser- appeals appeals Complaints/
plaints/ plaints/ plaints/ plaints/ plaints/
vice-related handled and handled appeals SA-QMS
complaints/ feedback appeals appeals appeals appeals appeals
within 21 register.
appeals. given within handled. handled. handled. handled. handled.
working
21 working days.
day.
4.6.1.12:
Activities for PIC/S onsite Assessment
02 01 01 SA-QMS
Accession to assessment. report.
PIC/S.
4.6.1.13: Membership
Maintenance require- PIC/S Web-
05 01 01 01 01 01 SA-QMS
of PIC/S ments site.
Accession. fulfilled.
4.6.1.14:
Contri-
bution to
International
Standardiza- Trip / Meet-
Meetings
tion/ Quality 20 04 04 04 04 04 SA-QMS
attended. ing reports.
Management/
Quality Assur-
ance meet-
167
ings/Bench
markings.
168
Annex 2: COST IMPLEMENTATION MATRIX
FY
FY
FY
FY
FY
TOTAL
2020/21
2021/22
2022/23
2023/24
2024/25
ACTIONS
STRATEGIC
STRATEGIC
INTERVENTION
Strategic Objective 1: To improve the regulatory efficiency and effectiveness that ensure safe, efficacious and quality drugs
and health products.
1.1:
Strengthen
systems 1.1.1: Strength-
and institute en mechanism
regulatory to support
55,400,000 245,800,000 220,116,000 324,518,320 331,008,686 1,176,843,006
actions that actions for local
support drug manufac-
local drugs turing.
manufactur-
ing.
1.2.1: Strength-
en collaborative
programmes
with vet profes-
sional bodies,
MDA, local 1,260,500,000 1,044,496,800 1,065,386,736 1,182,494,471 1,206,144,360 5,759,022,367
government,
and vet
practitioners to
ensure safety,
1.2: efficacy and
Strengthen quality and en-
systems hance rational
and institute vet drug use.
actions that
support drug 1.2.2: Strength-
regulatory en collaborative
compliance programmes
with human
by human
health profes-
and vet sional bodies,
practi- MDA, local
tioners. government,
578,069,000 419,923,710 428,322,184 486,888,628 496,626,400 2,409,829,923
private clinical
practitioners to
ensure safety,
efficacy and
quality and en-
hance rational
human drug
use.
1.2.3: Strength-
en mechanisms
that support
164,525,000 76,025,000 77,545,500 129,096,410 131,678,338 578,870,248
compliance
169
with GDP, GPP,

GVP, GCP.
170
FY
FY
FY
FY
FY
TOTAL
2020/21
2021/22
2022/23
2023/24
2024/25
ACTIONS
STRATEGIC
STRATEGIC
INTERVENTION
1.3:
1.3.1 Establish
Strengthen
mechanisms
the research
to support ev-
capacity
idence-based
for making 412,396,470 507,108,600 517,250,772 527,595,787 538,147,703 2,502,499,333
drug regula-
evidence
tory research
-based drug
and decision
regulatory
making.
decisions.
1.4.1. Strength-
1.4:
en mechanism
Strengthen
for regulation
the systems,
of product
processes
assessment
and proce-
and evaluation,
dures for
authorization 4,748,965,302 3,692,678,373 3,127,651,940 3,190,204,978 3,036,256,070 17,795,756,663
pre-market
and conduct
authori-
of clinical and
zation of
field trials for
drugs and
drugs and
healthcare
health care
products.
products.
1.5.1 Improve
systems for ef-
fective control 588,052,110 626,951,000 639,490,020 652,279,820 665,325,417 3,172,098,367
of imports and
exports.
1.5.2: Enhance
systems for 292,600,000 618,420,000 630,788,400 643,404,168 656,272,251 2,841,484,819
1.5:
PMS.
Strengthen
the systems, 1.5.3. Strength-
processes en systems,
and proce- processes and
dures for procedures for 2,906,446,002 3,175,753,000 2,949,268,060 3,008,253,421 3,068,418,490 15,108,138,973
post-market testing drugs
and health care
authori-
products.
zation of
drugs and 1.5.4: Strength-
healthcare en system,
products. process and
[contd]... procedures for 3,111,792,538 3,529,782,538 3,600,378,189 3,672,385,753 3,745,833,468 17,660,172,485
enforcement
of laws and
regulations.
1.5.5: Enhance
coordination
and partner-
ship schemes 12,804,020
2,500,000 2,500,000 2,550,000 2,601,000 2,653,020
with relevant
agencies for
171
improved drug
surveillance.
172
FY
FY
FY
FY
FY
TOTAL
2020/21
2021/22
2022/23
2023/24
2024/25
ACTIONS
STRATEGIC
STRATEGIC
INTERVENTION
1.5.6: AMR rel-
evant National
Action Plan
1.5: integrated in
Strengthen the NDA annual 130,200,000 132,200,000 134,844,000 170,410,480 140,291,698 707,946,178
the systems, plans for imple-
processes mented on col-
and proce- laborative basis
dures for with relevant
post-market MDAs.
authori-
zation of 1.5.7. Strength-
drugs and en system,
healthcare processes and
products. procedures for 103,000,000 198,000,000 201,960,000 205,999,200 210,119,184 919,078,384
regulation of
drug advertise-
ments.
Sub-total: 14,354,446,422 14,269,639,021 13,595,551,801 14,196,132,437 14,228,775,085 70,644,544,766

Objective 1
Strategic Objective 2: To streamline the legal and regulatory framework for operational effectiveness of NDA.
2.1.1: Advocacy
strategy to
2.1: Advo-
include actions
cate for an
to influence
improved 431,084,000 581,084,000 592,705,680 604,559,794 616,650,989 2,826,084,463
necessary
regulatory
changes in the
framework.
legal frame-
work.
2.2:
Strength- 2.2.1: Strength-
en the en regulatory 270,100,000 213,250,000 217,515,000 221,865,300 226,302,606 1,149,032,906
regulatory requirements.
framework.
Sub-total: 701,184,000 794,334,000 810,220,680 826,425,094 842,953,595 3,975,117,369

Objective 2:
Strategic Objective 3; To increase public awareness, and stakeholder collaboration to support NDA regulatory.
3.1.1: Enhance
stakeholder
560,362,500 707,872,600 722,030,052 786,470,653 802,200,066 3,578,935,871
3.1: awareness and
Strengthen engagement.
mecha-
nisms for 3.1.2: Enhance
stakeholder drug regulatory
awareness IEC program
and engage- target sharing 0 0 100,000,000 102,000,000 202,000,000
-
173
ment. information
with public on
topic issues.
174
FY
FY
FY
FY
FY
TOTAL
2020/21
2021/22
2022/23
2023/24
2024/25
ACTIONS
STRATEGIC
STRATEGIC
INTERVENTION
3.2.1 Strength-
3.2:
en internal
Enhance
communication
internal
capacity to
corporate
project a strong 136,787,500 214,624,200 218,916,684 223,295,018 227,760,918 1,021,384,320
and public
corporate
relations
image.
function.
3.3: 3.3.1: Strength-

Enhance en the partner-
stakeholder ship strategy
collabo- to harness
ration and synergies and 1,274,400,000 1,289,200,000 1,314,984,000 1,341,283,680 1,368,109,354 6,587,977,034
partnership best practices
at national, in drug regula-
regional and
tion.
international
level.
Sub-total:
1,971,550,000 2,211,696,800 2,255,930,736 2,451,049,351 2,500,070,338 11,390,297,224
Objective 3;
Strategic Objective 4: To improve NDA institutional capacity to effectively and efficiently implement its functions.
4.1.1: Com-
pletion and
Equipping of
4.1 Enhance the laboratory Refer to Chap- Refer to Chap- Refer to Refer to Refer to Refer to
the NDA ter 9 ter 9 Chapter 9 Chapter 9 Chapter 9 Chapter 9
tower and
infrastruc-
ture and microbiology
facilities for lab (Mulago).
her capacity
growth. 4.1.2: Es-
tablishment/
132,100,000 290,440,000 296,248,800 302,173,776 308,217,252 1,329,179,828
construction of
regional offices.
4.2: 4.2.1: automate
Strengthen and integrated
and ensure all business 68,872,399 324,514,001
a sustain- 57,021,642 64,900,000 66,198,000 67,521,960
processes at
able man- NDA.
agement
information
system
through
automa- 4.2.2: Secure
tion and ICT infrastruc-
integration 643,861,629 804,231,791 820,316,427 836,722,755 853,457,211 3,958,589,813
ture across the
across the
organization.
organization
175
and other
relevant
MDAs.
176
FY
FY
FY
FY
FY
TOTAL
2020/21
2021/22
2022/23
2023/24
2024/25
ACTIONS
STRATEGIC
STRATEGIC
INTERVENTION
4.3.1 Harness
the Drug
Authority 1,892,577,174 1,890,841,254 1,928,658,079 1,967,231,241 2,006,575,866 9,685,883,615

oversight and
operation.
4.3.2: Enhance
institutional
development
through regular 916,047,500 1,172,685,000 1,196,138,700 1,220,061,474 1,244,462,703 5,749,395,377
reviews and
4.3: human capital
Strengthen development;
Corporate
Governance 4.3.4: Enhance
practices an effective
8,000,820,000 10,740,440,287 10,955,249,093 9,822,004,476 10,018,444,565 49,536,958,420
and Human administration
Resource system.
capacity.
4.3.5: Strength-
en internal 114,978,637 115,029,574 117,330,165 119,676,769 122,070,304 589,085,449
Audit oversight
4.3.6: Establish
mechanisms
- - - - - -
for timely ser-
vice delivery.
4.4.1 Strength-
4.4: En- en mechanisms
hance the for resource
277,745,000 307,195,000 313,338,900 319,605,678 325,997,792 1,543,882,370
Institutional mobilization
resource and sustain-
mobilization ability.
capacity and
sustainabil- 4.4.2: Promote
ity. regulatory 19,402,995 0 0 0 42,597,471 62,000,466
self-financing.
4.5.1
Strengthen
planning and
4.5 programme 268,885,000 148,963,273 181,942,538 184,981,389 188,681,017 973,453,218
Strength- management
en the implementa-
corporate tion.
planning
4.5.2 Strength-
and perfor-
en risk
mance man- 91,960,000 131,960,000 194,599,200 297,291,184 201,237,008 917,047,392
management
agement
system.
systems.
4.5.3 Strength-
en M&E 20,520,000 17,300,000 217,646,000 327,998,920 18,358,898
177
601,823,818
system.
178
FY
FY
FY
FY
FY
TOTAL
2020/21
2021/22
2022/23
2023/24
2024/25
ACTIONS
STRATEGIC
STRATEGIC
INTERVENTION
4.6
Strengthen
the Quality
4.6.1 Strength-
Manage-
en the Quality
ment 537,900,000 514,344,000 524,630,880 535,123,498 545,825,968 2,657,824,345
Management
Systems
Systems.
across the
organiza-
tion.
Sub-total: 12,973,819,578 16,198,330,179 16,812,296,783 16,000,393,120 15,944,798,453 77,929,638,113
Objective 4:
TOTAL
30,001,000,000 33,474,000,000 33,474,000,000 33,474,000,000 33,516,597,471 163,939,597,472
NON-WAGE
BUDGET SUMMARY
WAGE 34,461,275,637 36,727,391,277 38,784,125,188 40,956,036,199 43,249,574,226 194,178,402,528
NON-WAGE 30,001,000,000 33,474,000,000 33,474,000,000 33,474,000,000 33,516,597,471 163,939,597,472
DEVELOPMENT 19,371,000,000 34,309,000,000 25,358,000,000 25,358,000,000 22,808,000,000 127,204,000,000
TOTAL 83,833,275,637 104,510,391,278 97,616,125,188 99,788,036,200 99,574,171,698 485,322,000,000
179
Annex 3: Organogram
MACRO ORGANISATION STRUCTURE
- REVISED 21ST NOVEMBER 2019
THE DRUG
AUTHORITY
AUDIT
COMMITTEE
SECRETARY TO
THE AUTHORITY
DIRECTOR DIRECTOR DIRECTOR

PRODUCT DIRECTOR INSPECTORATE &
ASSESSMENT LABORATORY ENFORCEMENT
PRODUCT SAFETY
& REGISTRATION SERVICES SERVICES
HEAD HEAD HEAD

INTERNAL REGIONS ENFORCEMENT
AUDIT
MANAGER MANAGER MANAGER MANAGER MANAGER

TRADITIONAL & LABORATORY PHARMACO- REGIONAL IMPORTS &
COMPLIMENTARY QUALITY MGT
SYSTEMS VIGILANCE OFFICE [7] EXPORTS
MEDICINE
MANAGER
MANAGER CLINICAL MANAGER
MEDICINES TRIALS GMP
MANAGER
MEDICINES
MANAGER MANAGER
MEDICAL POST MARKET
DEVICES SURVEILLANCE
180
DIRECTOR
CORPORATE
SERVICES
HEAD HEAD
HEAD HEAD HEAD HEAD LEGAL VETERINARY
PROCUREMENT HR & ADMIN ICT FINANCE SERVICES PRODUCTS
BUSINESS MANAGER
MANAGER PLANNING & INTERNATIONAL
ADMINISTRATION DEV’T MANAGER AFFAIRS
MANAGER
PUBLIC
RELATIONS
MANAGER
QMS
MANAGER
Approved by the Sixth Authority on 21st November 2019. RESOURCE
Effective date 19th March 2020. MOBILISATION
181
Annex 4: Key NDA Envisaged Risk Matrix
QUALITATIVE RISK ASSESSMENT

Objectives
SP
Description
Risk
Impact
Risk
Root Cause
Risk Driver/
Measure
Mitigation
Risk
Existing
Category
Type
Context
Risk
FOCUS AREA 1: CORE SERVICE DELIVERY:
Existence Gaps in Failure to *Lack of Existing

of sub- systems, fulfill the a national guidelines
standard, process- regulatory supply chain on regula-
falsified es and mandate management tory supply
and unsafe, procedures Damage strategy. chain GPP,
non-effec- in pre and on reputa- *Weak Collabora-
Strategic tive prod- post-mar- tion collaborative tion with
Objective 1: ucts on the keting Financial system to MDA on
To improve market. authori- loss due to track prod- actions to
the regulatory zation of litigation ucts from deter un-
the product
OPERATIONAL
efficiency and drugs and ADR authorized

effectiveness source.
healthcare AMR/APR *Inadequate products
that ensure products. Death reaching the
automation
safe, effica- of the track market.
cious and and trace Conducting
quality drugs system of enforce-
and health *Lack of ment and
care products. access to intelligence
[contd...] essential gathering.
drugs.
The public
Violating the
regulations,
and guide-
lines.
182
QUANTITATIVE RISK RISK TREATMENT

ASSESSMENT
Likelihood
Consequence
Risk Rating
Mitigation
Risk
Additional
Actions for
strategic
Proposed
Opportunity
Opportunities
Response to
Responsibility
2 5 10 Contribute to the devel- Receptive Consider a DIE
opment of a National public/pub- whistleblow-
supply chain strategy. lic support er incentive
Strengthen collaboration through strategy to
with MDA on actions increased enhance the
to deter unauthorized reporting of effectiveness
products reaching the unscrupulous of this report-
market. operators in ing modality.
the phar- Harness the
Introduce an automated maceutical willingness for
track and trace system. sector. collaboration
Strengthen collaborative Supportive by National
enforcement and intelli- National, Regional and
gence gathering actions Regional and International
against the violation of international Collaboration.
the NDA law. collaborative
mechanisms.
183
Objectives QUALITATIVE RISK ASSESSMENT

SP
Description
Risk
Impact
Risk
Root Cause
Risk Driver/
Measure
Mitigation
Risk
Existing
Category
Type
Context
Risk
Breach of Non Cancelation Lack of Increasing
Regulatory conformity of WHO resources the
service with and ISO/ to finance resources
standards national IEC 17025 compliance base to
Strategic and and 9001 Lack of finance
Objective 1: international accreditations. structures compliance
To improve standards and policies to regulatory
the regulatory arising to implement service
efficiency and out of standards. standards
COMPLIANCE
effectiveness deficiencies
that ensure in High Continuous
processes, standards to review
safe, personnel attain and of the
efficacious and tool / maintain structure,
and quality equipment within the policies,
drugs and and country’s skills and
health care structure. context. resources
products. base to
meet/
implement
standards.
FOCUS AREA 2: LEGAL AND REGULATORY FRAMEWORK:
Deficiency Uncer- Failure to Gaps in Continuous

Strategic in the law/ tainty and fulfill the the law to review
Objective 2: regulatory complex- regulatory address the of the
To streamline as a result ity in the mandate. expanded structure,
COMPLIANCE
the legal and of the regulatory scope of policies,

expanded framework Damage delegated skills and
regulatory on reputa-
framework for scope of can chal- regulatory resources
products lenge the tion. products. base to
operational
effective- for authority’s meet/
regulation ability to Financial implement
ness of NDA. loss due to
[contd...] (condoms, deliver its standards.
masks etc) mandate. litigation.
184

ASSESSMENT
Likelihood
Consequence
Risk Rating
Mitigation
Risk
Additional
Actions for
strategic
Proposed
Opportunity
Opportunities
Response to
Responsibility
1 5 5 Invest in strengthening Supportive The collabora- SA-
the Quality Management regional and tion strategy QMS
Systems across the international include actions
collaborative to domesticate
organization. mechanisms and tap into
with regulatory
Harmonization
Project synergies aris-
collaborative ing from this
mechanisms opportunity.
with EAC,
African
Medicines
Regulatory,
WHO,
International
Organization
for
Standardization
(ISO),
Pharmaceutical
Inspection and
Certification
Scheme (PICS).
4 2 8 Consider advocacy Increased When enacted, SA-

actions to streamline scope of strategies for Legal
the legal and regulatory products to implementing
framework for be regulated the additional
operational effectiveness. under the functions and
UFDA when necessary
enacted from structures to
the current be considered
Bill. then.
185

SP
Description
Risk
Impact
Risk
Root Cause
Risk Driver/
Measure
Mitigation
Risk
Existing
Category
Type
Context
Risk
Authority Gaps in Failure to Gaps in A staff
service legal, fulfill the the law to complement
delivery fail existing regulatory address the in the legal
procedures mandate expanded department
to achieve and people scope of to manage
the agreed defi- Damage delegated the on-go-
standards. ciencies on reputa- regulatory ing and
provision tion products. up-coming
that inhibit legal frame-
OPERATIONAL
NDA to Financial Understaff- work review,

implement loss due to ing affecting advice and
service litigation achieve- litigation.
delivery ment of the Establish-
timelines performance ment of
and targets targets. the service
in pre and delivery
Strategic post-mar- timelines.
keting Performance
Objective 2: authori- monitoring
To streamline zation of and evalua-
the legal and drugs and tion mecha-
regulatory healthcare nisms.
framework for products .
operational
effectiveness Authority Limited Damage Gaps in Periodic re-
of NDA. sued with com- on reputa- NDP/A Act, view of legal
significant pliance tion and regu- guidelines to
conse- to drug lations with manage the
quence. regulations Financial respect to changing
through loss to regulation of delegated
COMPLIANCE
extensive litigation a new range regulatory

implemen- of product roles.
tation of ie masks,
guidelines condoms
on good Non
pharma- prohibitive
ceutical sanctions
practices. for non-reg-
ulatory
compliance.
186

ASSESSMENT
Likelihood
Consequence
Risk Rating
Mitigation
Risk
Additional
Actions for
strategic
Proposed
Opportunity
Opportunities
Response to
Responsibility
4 2 8 Consider actions to GOU invest- Institutional SA
streamline the legal and ment in the development
regulatory framework for national IT strategy to
operational effectiveness. backbone include invest-
and adoption ment in IT and
Automate and integrate of e-govern- systems inte-
business process for ment present gration with
timely and efficient opportunities common user
service delivery. for NDA to data bases and
harness IT platforms i.e.
to cost-ef- NMS-ERP.
fectively
undertake its
country-wide
medicines
regulatory
functions in
coordination
with other
MDAs.
2 2 8 Advocacy strategy Emerging IT integrated SA

should include actions to MDA Collab- strategy for
engage key stakeholders orative prac- automation
to seek consensus on tices that are of internal
necessary revisions. being driven processes and
Establish a client charter by the search sharing of da-
to address service gaps. for efficiency tabases among
to serve com- common user
mon public databases.
good through
adoption of
integrated IT
platforms.
187

SP
Description
Risk
Impact
Risk
Root Cause
Risk Driver/
Measure
Mitigation
Risk
Existing
Category
Type
Context
Risk
FOCUS AREA 3: STAKEHOLDER ENGAGEMENT AND COLLABORATION:
Damage To Anything Damage Gaps in Client

Reputation/ (staff con- on reputa- communi- charter to
Brand of duct, data tion cation and prioritize
NDA (Rep- integrity/ stakeholder stakeholder
utational breaches engagement. interests.
Risk). etc) that
affects the Third party PR strategy
public’s misconduct and struc-
percep- including ture.
tions regulatory
of NDA noncompli-
Strategic carries ance and
Objective 3: significant malice.
To increase risk and
public aware- may result
REPUTATION
ness, and in financial

stakeholder conse-
collaboration quences.
to support Further-
NDA regulato- more, a
ry functions. nonstop
[contd...] news
cycle and
a world
connected
by social
media
combine
to threaten
long-term
reputation
and brand
damage.
188

ASSESSMENT
Likelihood
Consequence
Risk Rating
Mitigation
Risk
Additional
Actions for
strategic
Proposed
Opportunity
Opportunities
Response to
Responsibility
3 4 12 NDA Should proactively Supportive Institution- SA-PR
create response plans National, al capacity
to quickly address the Regional and enhancement
public relations should a international strategy should
reputation event occur. collaborative focus on
Streamline communi- communi- seizing these
cation cation and mechanisms
awareness to achieve
Develop a stringent fraud mechanisms. efficiency
policy. like working
with Healthy
communica-
tion strategy
and National
medias.
189
QUALITATIVE RISK ASSESSMENT

Objectives
SP
Description
Risk
Impact
Risk
Root Cause
Risk Driver/
Measure
Mitigation
Risk
Existing
Category
Type
Context
Risk
Conflict in Weak col- Failure/ Weak collab- Collabora-
regulatory laboration delay to oration with tion with
Strategic with other
mandate deliver on other MDA MDA on
Objective 3: MDA to
occurs. the NDA to enlist their actions to
To increase enlist their mandate. support in deter un-
public aware-
STRATEGIC
support actions that authorized

ness, and in actions ensure safe, products
stakeholder that en-
sure safe, efficacious reaching
collaboration
efficacious and quality the market
to support
and quality drugs on the through
NDA regulato-
drugs on market. MOUs and
ry functions.
the mar- other mech-
ket. anisms.
FOCUS AREA 4: INSTITUTIONAL DEVELOPMENT:
Economic Businesses Failure to Performance Re-engi-

Slowdown/ all over the fulfill the of the econ- neering of
Slow world are regulatory omy business
declining,
Recovery earnings mandate. processes.
Strategic (Especially reduced,
Objective 4: because of and cuts in Business
To improve COVID-19) spending failure.
NDA in- by both
the public
stitutional
STRATEGIC
and private
capacity to sectors.
effectively
and efficiently This
implement economic
slowdown
its functions. and poor
[contd...] perfor-
mance
may have
a dimen-
sion on the
operations
of NDA.
190

ASSESSMENT
Likelihood
Consequence
Risk Rating
Mitigation
Risk
Additional
Actions for
strategic
Proposed
Opportunity
Opportunities
Response to
Responsibility
3 3 9 Strengthen collaboration Supportive Harness the SA-
with MDA to enlist their National, willingness for Legal
support for on actions Regional and collaboration
to share information international by National
and deter unauthorized collaborative Regional and
products reaching the mechanisms. International
market. Collaboration.
2 3 6 Monitor the Macro-eco- Willingness of Leverage on DCS-

nomic conditions. the Govern- economic the Fi-
ment of Ugan- economic nance
Conduct rigorous stress da to institute stimulus pack-
tests and considering economic ages related to
hypothetical scenarios stimulus health.
to assess NDA’s ability packages for
to weather an economic health.
downturn.
Review the financial

projection to reflect the
Macroeconomic effect.
Continued re-engineering
of business processes.
191

SP
Description
Risk
Impact
Risk
Root Cause
Risk Driver/
Measure
Mitigation
Risk
Existing
Category
Type
Context
Risk
Staff Safe- Occu- Injuries Limited Staff insur-
ty, Security pational Death working ance policy.
And Health health Litigation space.
hazard
OPERATIONAL
and safety and com- Occupation-

occurs hazards pensation Lack of al health
may lead cost protective and safety
to injury wear. policies.
resulting
in litigation Disease
and finan- outbreaks in
cial loss. the Country.
Strategic
Objective 4:
To improve Cyber At- Business Denial and Weak ICT Provision of
NDA in- tack/Data automation disrup- security robust cyber
stitutional Breach increases tion of controls to control
capacity to vulnera- business prevent cy- mechanisms
effectively bility to operations. ber attack. including,
and efficiently cyber-at- Obsolete/ firewalls,
implement tacks. rely- Increased outdated ICT network ac-
its functions. systems to cess control
TECHNOLOGICAL
ing heavily cost of

[contd...] on digital operation match global etc.
technology IT environ-
to increase Client ment. Disaster
efficiency dissatis- recovery
and com- factions plan.
petitive- BCP.
ness are in Financial
particular losses.
danger.
192

ASSESSMENT
Likelihood
Consequence
Risk Rating
Mitigation
Risk
Additional
Actions for
strategic
Proposed
Opportunity
Opportunities
Response to
Responsibility
4 4 16 Enhance occupational Approved Seize the DCS-
health and safety actions National Insur- opportunities HR
Improve on the work ance policy for arising out
space and environment. of the National
Insurance.
4 5 20 Scale up the disaster GOU invest- Institutional CS-

recovery plan. ment in the development ICT
national IT strategy to im-
Increase internal aware- backbone prove invest-
ness of cyber related and adoption ment in IT and
threats. of e-govern- systems inte-
ment present gration with
Acquire more firewalls. opportunities common user
for NDA to data bases and
harness IT platforms i.e.
to cost-ef- NMS ERP.
fectively
undertake its
country-wide
medicines
regulatory
functions in
coordination
with other
MDAs.
193

SP
Description
Risk
Impact
Risk
Root Cause
Risk Driver/
Measure
Mitigation
Risk
Existing
Category
Type
Context
Risk
Business/ Poor busi- Business Volatility of Re-engi-
Financial ness and failure. the econo- neering of
perfor- financial my. business
mance perfor- processes.
leading to mance
FINANCIAL
cashflow increases
fluctu- vulnera-
ations/ bility and
liquidity inhibits
Risk. continu-
Strategic ity of the
Objective 4: operation
To improve of NDA.
NDA in-
stitutional
capacity to Failure To Non Cancel- Lack of Continuous
effectively Attract confor- ation of talented review of
and efficiently and/Or mity with accredita- personnel the reward
implement Retain Top national tions. to meet policies, to
its functions. Talent/ and inter- compliance attract and
[contd...] Human national Damaged standards. retain staff.
OPERATIONAL
resource standards repetition.

risk. arising out Existence of
of defi- the human
ciencies in resource
processes, manual with
personnel favourable
and tool/ employment
equipment terms.
and struc-
ture
194

ASSESSMENT
Likelihood
Consequence
Risk Rating
Mitigation
Risk
Additional
Actions for
strategic
Proposed
Opportunity
Opportunities
Response to
Responsibility
2 3 6 Strengthen resource Global shift Policy advoca- DCS
mobilization. towards cy strategies
self-financing to incorporate
mechanisms actions to
to support institutionalize
regulatory the self-financ-
activities. ing concept in
NDA’s regula-
tory business
model.
2 4 8 Review of staff reward Increased Collaborate DCS-

system to periodically number with training HR
align with regulatory qualified per- institutions,
needs. sonnel from Government
the training and other
Improve succession institutions to bodies for
planning. take up job identification of
positions. personnel.
Improve the staff struc-
ture that is competitive
with other Government
bodies.
195

SP
Description
Risk
Impact
Risk
Root Cause
Risk Driver/
Measure
Mitigation
Risk
Existing
Category
Type
Context
Risk
Third party Failure by Failure to Gaps in the Mechanisms
service third party deliver on contracting in place for
providers providers mandate. processes. contract
fail to per- to deliver manage-
form
OPERATIONAL
business Disruption ment and

critical of opera- monitoring.
services tions. Issuance of
and prod- service level
ucts will Financial agreements
impact on loss. Insurance
delivery of Contract
Strategic mandate. Litigations. performance
Objective 4: guarantees.
To improve
NDA in-
stitutional Shortage of NDA has a Failure to Expanding Continuous
capacity to Infrastruc- substantial fulfill the work loads upgrade
effectively ture and portion regulatory and range of of infra-
and efficiently facilities of their mandate regulatory structure
implement its to meet activities Damage services. investment
functions. the NDA’s being facil- on reputa- needs.
needs.
OPERATIONAL
ity-based tion.
lack of
which Financial
infrastruc- loss to
ture and litigation.
facilities
inhibits the
ability to
conduct its
opera-
tions .
196

ASSESSMENT
Likelihood
Consequence
Risk Rating
Mitigation
Risk
Additional
Actions for
strategic
Proposed
Opportunity
Opportunities
Response to
Responsibility
3 4 12 Strengthen third party Guiding Utilize the SA-
due diligence review framework PPPDA legal PDU
processes. through PPDA framework.
Improve contract man- Listed third Reference
agement monitoring and party provid- check with
reporting mechanisms. ers with other other Govern-
Government ment bodies on
bodies. credible third
party providers.
2 3 5 Review and procure- The Corvid-19 Institutional SA-

ment of infrastructure pandemic development DCS
and tooling needs to ramifications strategy should
periodically align with have raised include capac-
regulatory needs. the signif- ity up-grades
icance of (of tools,
investment processes,
in the Health HR) to engage
Sector in in emerging
general and collabora-
medicines tive actions
regulation relevant to its
processes and functions.
best practices
in particular.
197
Key to; Consequence / impact matrix
DESCRIPTION EXAMPLES OF IMPACT
• Life threatening.
• Authority would not be likely to survive.
• Sustained, serious loss in market share.
• Loss of brand value where the cost of future brand
Extreme
investment outweighs the recovery.
• Loss of key alliances and principals
• Ongoing crisis management and direction by the
Authority and senior management.
• Extensive injuries.
• Major impact on business with serious damage to
Authority ’s ability to service customers.
• Serious diminution in brand value and market share with
Major adverse publicity.
• Key alliances/principals are threatened.
• Litigation.
• Events and problems will require Authority and Senior
Management attention.
• Medical treatment required.

• Significant impact on the business – would affect
customers.
Moderate • Market share and/or brand value will be affected in the
short-term.
• Event will require senior and middle management
intervention.
• No injuries.
• Insignificant impact on internal business.
Low • No potential impact on market share.
• No impact on brand value.
• Issues would be delegated to junior management and
staff to resolve.
198
Designed and printed with support from WHO Uganda.
199
NATIONAL DRUG AUTHORITY HEAD OFFICE
AND REGIONAL OFFICES CONTACTS
ARUA
LIRA
HOIMA
TORORO
JINJA
KAMPALA
MBARARA
NATIONAL DRUG AUTHORITY NORTHERN REGION OFFICE WESTERN REGION OFFICE

Head Office Plot 48 Ogwal, Ajungu Road, Plot 30, Old Tooro Road,
Plot 19 Lumumba Avenue, P. O. Box 235, Lira Muganwa Centre,
P. O. Box 23096, Kampala, Uganda Tel / Fax: +256 473 420 652 P. O. Box 192, Hoima
Tel: +256 417 788 100/1 Tel / Fax: +256 465 440 688
+256 417 788 124 SOUTH WESTERN REGION
+256 417 788 129 OFFICE
Toll Free: 0800 101 999 House 29, Mbaguta Estates
Kamukuzi,
QUALITY CONTROL LABORATORY P. O. Box 1886, Mbarara WEB: www.nda.or.ug
Tel: +256 414 540 067 Tel: +256 485 421 088 MAIL: ndaug@nda.or.ug
Fax: +256 485 421 220
CENTRAL REGION OFFICE FACEBOOK: Uganda National Drug
Plot 1-2 Jinja Road, EASTERN REGION OFFICE Authority
Premier Compley Building Nakawa Plot 26 Kwapa Road,
P. O. Box 40082, Kampala P. O. Box 453, Tororo WHATSAPP: +256 791 415 555
Tel: +256 312 261 584 Tel / Fax: +256 454 445 195
TWITTER: @UNDAuthority
WEST NILE REGION OFFICE SOUTH EASTERN REGION OFFICE INSTAGRAM: Uganda National Drug
Plot 1, Mount Wati Road, Anyafio Plot 16 Rippon Garden Road, Authority
P. O. Box 1034, Arua P. O. Box 1710, Jinja
Tel: +256 372 260 087 Tel / Fax: +256 434 122 176

NDA Strategic Plan

Uploaded by

Document Information

Original Description:

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

NDA Strategic Plan

Uploaded by

Copyright:

Available Formats

NATIONAL DRUG AUTHORITY

MANDATE VISION MISSION

CORE VALUES CONTRIBUTION TO THE HEALTH

NDA REGULATORY FUNCTIONS

a) Deal with the development and regulation of the pharmacies

THE 7TH DRUG AUTHORITY

THE NATIONAL DRUG AUTHORITY

Dr. David Nahamya

Dr. Denis Mwesigwa Dr. Juliet Okecho Dr. Helen Ndagije

Mr. Rogers Kayita Mr. Wilberforce Kwiringira

The National Drug

Drugs and healthcare products are a key input for quality

I will ensure that as the Ministry we continue to support

For God and my Country.

Dr. Jane Ruth Aceng

The main goal of this strategic plan is “to attain and

The plan has been developed through a rigorous

Over the next five years, we will deliver services to our

1. Core Service Delivery; This focuses on the core functions of

The Drug Authority takes pride in being part of the country’s

Dr. Medard Bitekyerezo

The National Drug

This strategic plan comes at a time when the world

I must note that the pandemic has presented a number of

The Management of NDA assures the public that we will

The Management and Staff of NDA commit to the

National Drug Authority would like to appreciate our key

Special thanks go to the following individuals that

Dr. Joseph Mwoga

Dr. Sarah Nahalamba Birungi

Dr. Joseph Muvawala

National Drug Authority Ultra Modern Laboratory Tower.

ADR Adverse Drug Reaction

NDQCL National Drug Quality Control Lab

EXECUTIVE SUMMARY ....................................................................................................... XIX

2.0 CHAPTER TWO: SITUATIONAL ANALYSIS .............................. 6

3.0 CHAPTER THREE: STRATEGIC DIRECTION ...................... 40

4.0 CHAPTER FOUR: FINANCING OF THE PLAN .................... 62

5.0 CHAPTER FIVE: IMPLEMANTATION ARRANGEMENTS

5.1 Institutional arrangements for Plan implementation ................. 73

6.0 CHAPTER SIX COMMUNICATION AND FEEDBACK

7.0 CHAPTER SEVEN: MONITORING AND

8.0. CHAPTER EIGHT: ENTERPRISE RISK

9.0 CHAPTER NINE: PROJECT PROFILES ................................... 100

Annexes .................................................................................................................................................... 104

The NDA Strategic Plan 2020-2025 has been developed

The overall goal of the strategy for this medium term is to

Four strategic objectives have been developed, one for

1. To improve the regulatory efficiency and effectiveness

7. Enhanced digital transformation for regulatory effectiveness.

A Monitoring and Evaluation Plan has been put in place

The strategic plan has been appropriately costed and

This five-year plan for the period 2020/21-2024/25 builds

1.2 The Legal Framework of NDA

The National Drug Authority was established in 1993 by

1. Development 2. Control the 3. Encourage 4. Promote and 5. Promote rational

6. Establish and revise 7. Provide advice and 8. Approve the 9. Estimate

1.3 Governance and Organizational Structure

National Drug Authority, headed by the Secretary to

1.4 The National Legal and Policy Context of NDA

To consolidate and accelerate the development growth

harnessing opportunities, though agriculture, industrialization,

The Plan is aligned to the EAC Vison 2050, by creating a