Building Regulatory Capacity in Countries to Improve the

Regulation of Health Products

MVP| RHT | RSS | CRS www.who.int

Overall regulatory systems’ maturity level of
WHO Member States

ML 3 and 4
50 Countries
26%
ML 1
99 Countries
51%

ML 2
45 Countries
23%

(Updated 15 May 2018)

WHO MVP/RSS/CRS

2
Global context
08/10/2018 4
 SDG 3 – Target 3.8

Achieve universal health coverage, including financial risk protection,

access to quality essential health-care services and access to safe,
effective, quality and affordable essential medicines and
vaccines for all.

08/10/2018 5
 WHA Resolution 67.20
What WHO should do
To continue to support Member States upon their request in the area of
regulatory system strengthening, including, as appropriate, by
continuing to:

Evaluate national regulatory systems

Apply WHO evaluation tools

Generate and analyze evidence of regulatory system performance

Facilitate the formulation and implementation of institutional development plans

Provide technical support to national regulatory authorities and governments

08/10/2018 6
 WHA Resolution 67.20
What WHO should do

Norms and Capacity building

standards in developing Networks
countries

Medical devices
including WHO
ICDRA PQ program
Diagnostics

Health system International and Regulation of

strengthening regional complex
collaboration biological

08/10/2018 7
WHO capacity building model
 WHO NRA 5 step capacity building

• Eligibility for vaccine PQ

• Minimal capacity met

• WHO listed NRAs

Formulation of Providing technical
Development of Institutional Monitoring
Benchmarking of support,
NRA progress and
NRA Development Plan Training/Learning,
benchmarking tool impact
(IDP) networking,

1 2 3 4 5

08/10/2018 9
 From gap analysis to capacity building

• Assessment report
Gap Technical
Global Support Placement,
analysis Learning In-county and on joint review
Opportuni workshop site , twining,
ties (GLO) consultan others
• Recommendations & ts
activities to address it
IDP

• Providing technical support

• Learning/Training/internationa
Addressing
gaps
l cooperation Regulatory functions targeted:
1.NATIONAL REGULATORY SYSTEM
2.REGISTRATION AND MARKETING
• IDP follow-up : progress and AUTHORIZATION
impact 3.LICENSING OF PREMICES
• Re-assessment to sustain PQ or 4.MARKET SURVEILLANCE AND CONTROL
Monitoring
progress and
NRA functionality until expected 5.VIGILANCE
impact maturity is achieved 6.REGULATORYINSPECTIONS
7.CLINICAL TRIALS OVERSIGHT
8.LABORATORY ACCESS AND TESTING
9.NRA LOT RELEASE

08/10/2018 10
WHO Global Benchmarking Tool
08/10/2018 | Title of the presentation 12
 WHO Global Benchmarking Tool
Structure/Hierarchy

SYSTEM FUNCTION

INDICATORS

SUB-INDICATORS

QUESTIONNAIRE FOR
OTHER PRODUCTS THE FACT
/ACTIVITIES SHEET

08/10/2018 13
 WHO Global Benchmarking Tool
Structure/Hierarchy
National Regulatory System (NRS) and Functions (NRF)

SYSTEM FUNCTION

INDICATORS

1. Regulatory System + Common Function

2. Non Common Functions
SUB-INDICATORS

QUESTIONNAIRE FOR Common Function Non Common Functions

OTHER PRODUCTS THE FACT
01-NATIONAL REGULATORY SYSTEM 09-NRA LOT RELEASE
/ACTIVITIES 02-REGISTRATION AND MARKETING SHEET
AUTHORIZATION
03-VIGILANCE
04-MARKET SURVEILLANCE AND CONTROL
05-LICENSING PREMISES
06-REGULATORY INSPECTION
07-LABORATORY ACCESS AND TESTING
08-CLINICAL TRIAL’S OVERSIGHT

08/10/2018 14
 WHO Global Benchmarking Tool
Structure/Hierarchy
Indicators Categorization (cross cutting subjects)

SYSTEM FUNCTION

INDICATORS

Categories enable assessment of cross sectional subjects (across

some and/or all functions)
SUB-INDICATORS
1. Legal provisions, regulations and guidelines
QUESTIONNAIRE FOR 2. Organization and governance
OTHER PRODUCTS 3. Policy and strategic planning THE FACT
/ACTIVITIES 4. Leadership and crisis management SHEET
5. Transparency, accountability and communication
6. Quality and risk management system
7. Regulatory process
8. Resources (HR, FR, Experts, Infrastructure, Equipment
and IMS)
9. Monitoring progress and assessing impact

08/10/2018 15
 Updated Figures of the WHO GBT
revision VI

Grand
Item Function RS MA VL MC LI RI LA CT LR Total

Number of Sub-
60 35 26 27 19 26 28 30 17 268
Indicators
Sub-Indicators
measuring maturity level 4 6 5 3 2 3 2 2 1 28
1
Sub-Indicators
measuring maturity level 7 2 3 4 1 2 2 8 3 32
2
Minimal
capacity Sub-Indicators
measuring maturity level 27 23 14 15 13 13 18 17 11 152
3
Advanced/r Sub-Indicators
eference measuring maturity level 22 4 4 5 3 8 6 3 2 56
NRAs 4

* As per the last WHO – PAHO agreement, maturity level 5 will be parked for the time being so it will not be considered during our current exercise. Maturity level concept is detailed further in slide 11.

08/10/2018 WHO-PAHO working group discussions for revision and finalization of the Global Benchmarking Tool (GBT) 16
 WHO GBT Performance Maturity Levels

1 2 3 4
ISO 9004

Reactive Stable formal Continual

No formal
approach system approach improvement
approach
emphasized

Some elements Evolving national Stable, well- Regulatory system

WHO GBT

of regulatory regulatory system functioning and operating at

system exist that partially
performs essential
regulatory
functions
Can be consider as functional if
rely on other regulators for some
specific functions
integrated advanced level of
regulatory system performance and
continuous
improvement
Target of WHA Advanced/reference
Resolution 67.20 Regulatory Authorities

08/10/2018 17
 Model for adoption of Maturity Level
Concept Maturity Level Spider Web
• By adoption of the maturity level
RS
concept, gaps are easily figured out 4
(inter-and-intra regulatory functions)
CT 3 MA
and hence capacity building
priorities are defined as shown in 2
this example!
1
LA 0 VL
• In addition, maturity level adoption
enable customization of the tool for
benchmarking of NRAs of varying
capacities. IN MC

LI Maturity Level

08/10/2018 18
Bangladesh road map (2016-2020)
Mid year review
Roadmap Annual review

Self-assessment 5 years Institutional Development Plan

Interim Formal
Assessment Assessment

2016 2017 2018 2019 2020

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Bangladesh Roadmap 2016

Drug policy
IDP development
Drug act Workforce analysis

Assessment
Annual Progress
Task force report
Oversight committee
Roadmap Oversight meeting
committee

Strategic plan

Q1 Q2 Q3 Q4
2016
20
 Recommended activities to be included
in Institutional Development (IDP)
Regulatory functions Total number of No. of
Recommendatio recommendation
ns s required to
reach ML3
01-NATIONAL REGULATORY SYSTEM (RS) 29 10
02-REGISTRATION AND MARKETING AUTHORIZATION (MA) 28 12
03-VIGILANCE (VG) 16 9
04-MARKET SURVEILLANCE AND CONTROL (MC) 10 1
05-LICENSING PREMISES (LI) 5 1
06-REGULATORY INSPECTION (RI) 13 4
07-LABORATORY ACCESS AND TESTING (LA) 3 1
08-CLINICAL TRIAL’S OVERSIGHT (CT) 15 10
09-NRA LOT RELEASE (LR) 5 2
Total 123 50

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 Country IDP implementation
estimated cost

Function/ area for Regulatory Strengthening Current Estimated cost to

Maturity Level reach to Maturity
level 3
1. National Regulatory System (RS) 1 330,000 USD
2. Registration and Marketing Authorization (MA) 2 180,000 USD

3. Vigilance (VL) 1 240,000 USD

4. Market Surveillance and Control (MC) 1 450,000 USD
5. Licensing Premises (LI) 2 150,000 USD
6. Regulatory Inspection (RI) 2 450,000 USD
7. Laboratory Access and Testing (LA) 2 750,000 USD
8. Clinical Trials Oversight (CT) 1 450,000 USD
9. NRA lot Release NA 0 USD
Total estimated cost 3,000,000 USD
Innovative Approaches Toward
Regulatory System Strengthening
The Future: new business model
and innovative approaches

CIP
Update on
WHO Listed Authorities

25
WHO Listed Authority

 Term ‘Stringent Regulatory Authority’, defined as original ICH

member/observer, was developed to promote reliance and guide
procurement decisions - widely used and recognized
 However, growing recognition that change required, with interim
definition endorsed by WHO Expert Committee at 51st meeting (Oct 2016)
based on membership of ‘original ICH’
 Concerns with term SRA; with the fact that ICH is a harmonization
initiative for pharmaceuticals, not a body with a remit or competence to
assess regulatory capacity; coupled with expanding membership
 Experts at 52nd meeting (Oct 2017) considered new WHO proposal and
comments received, made a number of recommendations

26
Expert Committee
Recommendations

• Term SRA be replaced by “WHO-Listed Authority” (WLA)

• Currently identified “SRAs” will be regarded as WHO-
Listed
• Designation of additional NRAs be based on WHO Global
Benchmarking Tool (GBT) + completion of ‘confidence-
building process’
• Procedure for listing be developed through usual public
consultation process

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Establishing a system for recognizing
and listing WLA

 Concept note under development that will

• present proposed definition for WLA
• define proposed criteria and process for designating an NRA as WLA
• describe the proposed process and timelines for finalizing the definition and
process for designating a WLA

 Given implications, WHO intends to undertake a broader consultation process

 Targeting early 2019 for adoption, together with introduction of WHO Global
Benchmarking Tool (version VI)

 Transition phase foreseen

 Definition must be assessed in context of existing WHO guidelines

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Fact and figures
GLOBAL OVERVIEW
WHO NRA Assessment Visits: 1997

08/10/2018 30
WHO NRA Assessment Visits: 2015

08/10/2018 31
 Countries targeted for WHO Regulatory System Strengthening
Program and benchmarked against GBT indicators between
January 2016 to March 2018

Formal Benchmarking Self Benchmarking

• India • Afghanistan
• Pakistan
• Papua new guinea
• Vietnam
• Timor-Leste • Malaysia
• Tanzania • Japan
• Iraq
• Burundi
• Jordan
• Ethiopia • Lebanon
• Mozambique • Mongolia
• Kyrgyzstan
• Kenya
• S. Korea
• Djibouti • Bangladesh
• Eritrea • Iran
• Syria
• Sudan
• Kazakhstan
• South Sudan • Ghana • Egypt
• Maldives
• Somalia • Guinea Bissau • Nepal • Saudi Arabia
• Liberia • Sri Lanka • Gambia
• Uganda • Niger • Thailand • Benin
• Serbia • Cape Verde • Bhutan • Burkina Faso
• Nigeria • Indonesia • Guinea
• Cambodia
• Cote d’ivoire • Togo • Sierra Leone
• Lao PDR (Updated 13 March 2018)
WHO MVP/RSS/CRS • Senegal • Mali • Rwanda

The boundaries and names shown and the designations used on this map do not imply the expression of any opinion whatsoever on the part of the World Health Organization (WHO) concerning the
legal status of any country, territory, city or area of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on map represent approximate border lines for which there
may be not yet be full agreement.
 STRENGTHENING NATIONAL REGULATORY AUTHORITY
(NRA) TRAINING CONDUCTED 1996-2018
8434 PARTICIPANTS FROM NRAs, NCLs*, EPIs** AND/OR VM***
AFR
WPR
1368
1837
16%
22%

AMR
1024
8434 head counts
12%
have been trained
by WHO between
1996 till July 2018

EMR
SEAR 1140
1810 14%
21%

* National Control Laboratory EUR

** Expanded Programme on Immunization
*** Vaccine Manufacture
1255
Source: WHO/ EMP 15%
08/10/2018 | Title of the presentation 33
Major challenges
• Absence of national policy and strategic objectives for establishing
and/or developing further a National Regulatory Authority (NRA)

• Lack of minimum resources to establish and sustain regulatory

oversight

• Unclear vision and mission (what should be done and what should not)
• Avoiding duplication, reliance and recognition
• Regulatory activities that could be done collectively by countries

• Access vs. quality

• Long term process, required continues commitment and engagement

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Important Links
Go to our Regulatory
system strengthening Go to the Global
website Benchmarking Tool

Go to SharePoint site
Go to GBT online training

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CRS Group

Sillo, Hiiti Baran

ALFONSO, Claudia
Silloh@who.int alfonsoc@who.int

KHADEM BROOJERDI, Alireza

khadembroojerdia@who.int EL HEMSY, Samir M.A. Abdel Wahab
awahabs@who.int

OSTAD ALI DEHAGHI, Razieh

ostadalidehaghir@who.int
MELOUNOU, Yvonne
melounouy@who.int
BROWN, Laura Kay
brownl@who.int

REFAAT, Mohamed
refaatm@who.int
YAP, Maria Bernadette
yapm@who.int

36
Overall regulatory systems’ maturity level of
WHO Member States

ML 3 and 4
50 Countries
26%
ML 1
99 Countries
51%

ML 2
45 Countries
23%

(Updated 15 May 2018)

WHO MVP/RSS/CRS

37
 Thank you

Dr Alireza Khadem

Email: khadembroojerdia@who.int

Regulatory Systems Strengthening (RSS)

Regulation of Medicines and Other Health Technologies (RHT)
World Health Organization (Geneva, Switzerland)