Marketing Authorization
procedures & Premarketing
requirements of Drug Product
Registration in SEA countries
Srinivasa Rao...
Contents
Introduction to ASEAN Region
Regulatory Framework in ASEAN
Region
Marketing Authorization Procedures In
Major ...
2
ASEAN Region
(Association of South East Asian
Nations)
8th Aug 1967
ASEAN
8th Jan1984
ASEAN 6
CLMV group
Joining
ASEAN D...
Origin of ACCSQ - PPWG
 The ASEAN Consultative Committee for Standards & Quality was
formed to facilitate & complement th...
4
Regulatory Framework in
ASEAN Region
Regulatory Framework in ASEAN
Region
5
Country Regulatory body Time line
Singapore
HSA 90 – 240 working
days
Malaysia
NPCB...
Marketing Authorization Procedures
In Major SEA countries
6
Marketing Authorization Procedures –
Singapore
7
Reference regulatory agencies refer to TGA, Health Canada, US FDA, EMA (C...
Registration Process
8
Application Submission
Application screening
Application evaluation
Regulatory Decision
Approval
No...
Marketing Authorization
Procedures Malaysia
9
Generics
Full Evaluation Abridged Evaluation
Scheduled Poison
Non-scheduled ...
Registration Process
10
Application Submission
Application screening
Application evaluation
Regulatory Decision
Approval
R...
Marketing Authorization Procedures
Thailand
 Submission requirements are based on
the type of generic product to be
regis...
Registration
Process
Submission is a two-step process
Step I: application for permission to manufacture or
import of drug ...
Marketing Authorization Procedures
Indonesia
Submission is a two-step process
◦ Pre registration : For screening drug regi...
14
HPR: Head of Agency submit letter
of Pre-Registration
Pre-registration application
Issuance of
HPR
Drug Registration Ap...
Comparative Table of Registration
Fees
15
Country Fees
Singapore 4,400 SD & next strength 2,750 SD (Abridged); 10,550 SD &...
Submission Requirements
16
Submission Requirements
 Asean Common Technical Dossier (ACTD)
 Dossier presentation similarities between
ACTD & ICH CTD...
Submission Requirements
 Major differences between ACTD & ICH
CTD
18
ACTD (Part II) ICH CTD (Module 3)
S 7 Stability – no...
Submission Requirements -
Samples
19
Country R/NR Pack (numbers) When
Singapore NR - -
Malaysia NR - -
Indonesia NR - -
Br...
Submission requirements -
Administrative Documents
Country CoPP Mfg License
GMP
certificate
Philippines R R R
Singapore R ...
Regulatory Challenges
21
GMP
Manufacturing facility should have PIC/S
approval to get acceptance for MA applications
in Singapore, Malaysia & Indo...
Regulatory Challenges
Specific Requirements:
Indonesia: decree 1010 of 2008
Singapore: Proof of API GMP manufacturing
fa...
Questions & Answers
24
25
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Marketing Authorization procedures & premarket requirements sea countries

  1. 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. 2. Contents Introduction to ASEAN Region Regulatory Framework in ASEAN Region Marketing Authorization Procedures In Major SEA Countries Submission Requirements Regulatory Challenges 1
  3. 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. 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. 5. 4 Regulatory Framework in ASEAN Region
  6. 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. 7. Marketing Authorization Procedures In Major SEA countries 6
  8. 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. 9. Registration Process 8 Application Submission Application screening Application evaluation Regulatory Decision Approval Non- Approval/ Withdrawal Non- Acceptance/ Withdrawal Application Acceptance
  10. 10. Marketing Authorization Procedures Malaysia 9 Generics Full Evaluation Abridged Evaluation Scheduled Poison Non-scheduled Poison 210 days 80 days
  11. 11. Registration Process 10 Application Submission Application screening Application evaluation Regulatory Decision Approval Rejected Application rejected Appeal
  12. 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. 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. 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. 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. 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. 17. Submission Requirements 16
  18. 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. 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. 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. 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. 22. Regulatory Challenges 21
  23. 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. 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. 25. Questions & Answers 24
  26. 26. 25
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