Marketing Authorization

procedures & Premarketing

requirements of Drug Product
Registration in SEA countries

Srinivasa Rao Moturi M.Pharm

Regulatory Affairs Manager,
Silom Medical International Co
Ltd
Thailand
 Contents
 Introductionto ASEAN Region
 Regulatory Framework in ASEAN
Region
 Marketing Authorization Procedures In
Major SEA Countries
 Submission Requirements
 Regulatory Challenges

1
 ASEAN Region
(Association of South East Asian
Nations)
The main objective of ASEAN is to accelerate the economic growth, social
progress and cultural development among its members & protection of
regional peace and stability.

8th Aug 1967

ASEAN

8th Jan1984
ASEAN 6

CLMV group
Joining

ASEAN Day:
8th August

2
 Origin of ACCSQ - PPWG
 The ASEAN Consultative Committee for Standards & Quality was
formed to facilitate & complement the ASEAN Free Trade Area
(AFTA)

 Efforts toward harmonization of ASEAN pharmaceutical

regulations were initiated through the ACCSQ & it leads to
formation of Pharmaceutical Product Working Group.

OBJECTIVE
◦ To develop harmonization schemes of pharmaceutical
regulations
◦ To eliminate technical barriers to trade posed by these
regulations with out compromising on drug quality, safety and
efficacy
VISION
◦ To create the ASEAN community with a common market by the
year 2020 3
Regulatory Framework in
ASEAN Region

4
Regulatory Framework in ASEAN
Region
Country Regulatory body Time line
HSA 90 – 240 working
Singapore
days
NPCB 80 – 210 working
Malaysia days
Philippines FDA 6 months

Myanmar Department of FDA 1 year

TFDA 70 to 110 working
Thailand days
Department of
1 year
Cambodia Drugs & food
NADFC 100 – 150 working
Indonesia days
Vietnam MOH 1 year
5
Marketing Authorization Procedures
In Major SEA countries

6
Marketing Authorization Procedures –
Singapore
Generic Drug
Applications (GDA)

Abridged Verification
CECA route
route route

Approved by
Approved by
regulatory Indian Generic products
reference
agency
regulatory agency

25 days 14 days
240 days 25 days 90 days
120 days
Reference regulatory agencies refer to TGA, Health Canada, US FDA, EMA (CP) and UK MHRA

7
Registration Process

Application screening

Non- Application Submission

Acceptance/
Withdrawal
Application Acceptance

Application evaluation Non-

Approval/
Withdrawal
Regulatory Decision

Approval

8
 Marketing Authorization
Procedures Malaysia
Generics

Full Evaluation Abridged Evaluation

Non-scheduled Poison
Scheduled Poison

80 days
210 days

9
Registration Process
Application Submission

Application
rejected
Application screening

Application evaluation

Regulatory Decision

Rejected

Approval

Appeal

10
 Marketing Authorization Procedures
Thailand
 Submission requirements are based on
the type of generic product to be
registered.

 Generics Classification
◦ Generic drug product
◦ New generic drug product

 Submission Pathways
◦ Standard review
◦ Accelerated/Priority review 11
 Registration
Process
Submission is a two-step process
Step I: application for permission to manufacture or
import of drug samples – One stop service center
Step II: Application for product registration
Application Submission

Pre filing screening review

Review by experts/committees

Regulatory Decision

Approval Edit/revise Rejection 12

 Marketing Authorization Procedures
Indonesia
Submission is a two-step process
◦ Pre registration : For screening drug registration,
determination of registration category &
determination of evaluation path

◦ Registration:
 Line of 40 days – Drugs for export
 Line of 100 days – Copy drugs of essential category &
drugs
with Standard electronic information
(Stinel)
 Line of 150 days – Copy drug with out Stinel
 Line of 300 days – New drugs 13
Registration Process

Pre-registration application

Evaluation within 40 days

In case of query, clock stops
Issuance of for 20 days
HPR

Drug Registration Application +

Dossier

Evaluation process

Registration Rejection
HPR: Head of Agency submit letter
of Pre-Registration
14
Comparative Table of Registration
Fees
Country Fees

Singapore 4,400 SD & next strength 2,750 SD (Abridged); 10,550 SD &

next strength 5,550 SD (Verification & CECA)

Malaysia 670 USD (1 API) & 910 USD (2 or more API)

Philippines 300 USD (Brand) & 220 USD (Generic)

Myanmar 400 USD

Thailand 65 USD

Cambodia 300 USD (1 API) & 500 USD (2 or more API)

Indonesia 650 USD

Vietnam 210 USD

200 BD as processing fees & 50 BD as maintenance fees per
Brunei year

Laos 100 USD

15
Submission Requirements

16
 Submission Requirements
 Asean Common Technical Dossier (ACTD)
 Dossier presentation similarities between
ACTD & ICH CTD
Documents ICH CTD ACTD
Administrative Documents and
Module 1 Part I
Product Information

Incorporated in
CTD Overview and Summaries Module 2
parts II, III & IV

Quality Documents Module 3 Part II

Non – clinical Documents Module 4 Part III

Clinical Documents Module 5 Part IV

17
 Submission Requirements
 Major differences between ACTD & ICH
CTD
ACTD (Part II) ICH CTD (Module 3)

S 7 Stability – no subsections 3.2.S.7 Stability – 3 subsections

P 2 Pharmaceutical Development
• 7 sub sections 3.2.P.2 Pharmaceutical Development
• P 2.1 Information on development studies • 6 sub sections
(additional)

3.2.P.3 Manufacture – 5 sub sections

P 3 Manufacture – 4 sub sections
• 3.2.P.3.1 Manufacturer (s) (additional)

3.2.P.4 Control of Excipients – 6 sub sections

3.2.P.4.3 Validation of analytical procedures
P 4 Control of Excipients – 4 sub sections
(additional)
3.2.P.4.4 Justification of specification (additional)

P 8 Stability – no subsections 3.2.P.8 Stability – 3 subsections

P 9 Product Interchangeability Equivalence This is not part of Module 3; covered separately in

Evidence Module 5

18
 Submission Requirements -
Samples
Country R/NR Pack (numbers) When
Singapore NR - -
Malaysia NR - -
Indonesia NR - -
Brunei NR - -
Philippines R 2 Initial submission
Vietnam R 2 Initial submission
Thailand R 2 Initial submission
Based on therapeutic
Cambodia R Initial submission
category
Based on therapeutic
Myanmar R Initial submission
category
Laos R As per dosage form Initial submission
*R: Required; NR: Not required 19
 Submission requirements -
Administrative Documents
GMP
Country CoPP Mfg License
certificate
Philippines R R R
Singapore R R PIC
Vietnam R/L R R
Thailand R R R
Malaysia R R PIC
Cambodia R R R
Indonesia R R PIC
Laos R R R
Brunei R R R
Myanmar R R R

R: Required; L: Legalized; PIC: Pharmaceutical Inspection Convention 20

Regulatory Challenges

21
 Regulatory Challenges
GMP
Manufacturing facility should have PIC/S
approval to get acceptance for MA applications
in Singapore, Malaysia & Indonesia.
Labeling
Country specific statements in local languages
Brand name positioning & font size
Differences in lead time to get authorization

Contd….
22
 Regulatory Challenges
Specific Requirements:
Indonesia: decree 1010 of 2008

Singapore: Proof of API GMP manufacturing

facilities & access is required for restricted part of
the DMF
 Malaysia: Planning to implement similar requirement

Thailand: Local bioequivalence study requirement to

register new generic drug products

23
Questions & Answers

24
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