1. 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

2. Contents
Introduction to ASEAN Region
Regulatory Framework in ASEAN
Region
Marketing Authorization Procedures In
Major SEA Countries
Submission Requirements
Regulatory Challenges
1

3. 2
ASEAN Region
(Association of South East Asian
Nations)
8th Aug 1967
ASEAN
8th Jan1984
ASEAN 6
CLMV group
Joining
ASEAN Day:
8th August
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.

4. 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

5. 4
Regulatory Framework in
ASEAN Region

6. Regulatory Framework in ASEAN
Region
5
Country Regulatory body Time line
Singapore
HSA 90 – 240 working
days
Malaysia
NPCB 80 – 210 working
days
Philippines FDA 6 months
Myanmar Department of FDA 1 year
Thailand
TFDA 70 to 110 working
days
Cambodia
Department of
Drugs & food
1 year
Indonesia
NADFC 100 – 150 working
days
Vietnam MOH 1 year

7. Marketing Authorization Procedures
In Major SEA countries
6

8. Marketing Authorization Procedures –
Singapore
7
Reference regulatory agencies refer to TGA, Health Canada, US FDA, EMA (CP) and UK MHRA
Generic Drug
Applications (GDA)
Abridged
route
Verification
route
CECA route
Approved by
regulatory
agency
Approved by
reference
regulatory agency
Indian Generic products
25 days
240 days 25 days
120 days
14 days
90 days

9. Registration Process
8
Application Submission
Application screening
Application evaluation
Regulatory Decision
Approval
Non-
Approval/
Withdrawal
Non-
Acceptance/
Withdrawal
Application Acceptance

10. Marketing Authorization
Procedures Malaysia
9
Generics
Full Evaluation Abridged Evaluation
Scheduled Poison
Non-scheduled Poison
210 days
80 days

11. Registration Process
10
Application Submission
Application screening
Application evaluation
Regulatory Decision
Approval
Rejected
Application
rejected
Appeal

12. 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

13. 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
12
Application Submission
Pre filing screening review
Review by experts/committees
Regulatory Decision
Approval Edit/revise Rejection

14. 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

15. 14
HPR: Head of Agency submit letter
of Pre-Registration
Pre-registration application
Issuance of
HPR
Drug Registration Application +
Dossier
Evaluation process
Registration
Evaluation within 40 days
In case of query, clock stops
for 20 days
Registration Process
Rejection

16. Comparative Table of Registration
Fees
15
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
Brunei
200 BD as processing fees & 50 BD as maintenance fees per
year
Laos 100 USD

17. Submission Requirements
16

18. Submission Requirements
 Asean Common Technical Dossier (ACTD)
 Dossier presentation similarities between
ACTD & ICH CTD
17
Documents ICH CTD ACTD
Administrative Documents and
Product Information
Module 1 Part I
CTD Overview and Summaries Module 2
Incorporated in
parts II, III & IV
Quality Documents Module 3 Part II
Non – clinical Documents Module 4 Part III
Clinical Documents Module 5 Part IV

19. Submission Requirements
 Major differences between ACTD & ICH
CTD
18
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
• P 2.1 Information on development studies
(additional)
3.2.P.2 Pharmaceutical Development
• 6 sub sections
P 3 Manufacture – 4 sub sections
3.2.P.3 Manufacture – 5 sub sections
• 3.2.P.3.1 Manufacturer (s) (additional)
P 4 Control of Excipients – 4 sub sections
3.2.P.4 Control of Excipients – 6 sub sections
3.2.P.4.3 Validation of analytical procedures
(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
Evidence
This is not part of Module 3; covered separately in
Module 5

20. Submission Requirements -
Samples
19
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
Cambodia R
Based on therapeutic
category
Initial submission
Myanmar R
Based on therapeutic
category
Initial submission
Laos R As per dosage form Initial submission
*R: Required; NR: Not required

21. Submission requirements -
Administrative Documents
Country CoPP Mfg License
GMP
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
20R: Required; L: Legalized; PIC: Pharmaceutical Inspection Convention

22. Regulatory Challenges
21

23. 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
22
Contd….
RegulatoryChallenges

24. 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

25. Questions & Answers
24

26. 25