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

Introduction to ASEAN RegionRegulatory Framework in ASEAN

RegionMarketing Authorization

Procedures In Major SEA CountriesSubmission RequirementsRegulatory Challenges

2

3

ASEAN Region (Association of South East Asian Nations)

8th Aug 1967ASEAN

8th Jan1984ASEAN 6

CLMV groupJoining

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.

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

◦ Recently this due date is advanced to 20154

5

Regulatory Framework in ASEAN Region

Regulatory Framework in ASEAN Region

6

Country Regulatory body

Time line

SingaporeHSA 90 – 240 working

days

MalaysiaNPCB 80 – 210 working

days

Philippines FDA 6 months

MyanmarDepartment of

FDA1 year

ThailandTFDA 70 to 110 working

days

CambodiaDepartment of Drugs & food

1 year

IndonesiaNADFC 100 – 150 working

days

Vietnam MOH 1 year

Brunei BDMCA 220 working days

Laos FDD 180 working days

Marketing Authorization Procedures In Major SEA

countries

7

Marketing Authorization Procedures – Singapore

8

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 days240 days 25 days

120 days

14 days90 days

Registration Process

9

Application Submission

Application screening

Application evaluation

Regulatory Decision

Approval

Non-Approval/

Withdrawal

Non-Acceptance/ Withdrawal

Application Acceptance

Marketing Authorization Procedures Malaysia

10

Generics

Full Evaluation Abridged Evaluation

Scheduled PoisonNon-scheduled Poison

210 days80 days

11

Registration Process

Application Submission

Application screening

Application evaluation

Regulatory Decision

Approval

Rejected

Application rejected

Appeal

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 12

Registration Process

Submission is a two-step processStep I: application for permission to manufacture or import of drug samples – One stop service centerStep II: Application for product registration

13

Application Submission

Pre filing screening review

Review by experts/committees

Regulatory Decision

Approval Edit/revise Rejection

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

14

15

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 daysIn case of query, clock stops for 20 days

Registration Process

Rejection

Comparative Table of Registration Fees

16

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

Brunei200 BD as processing fees & 50 BD as maintenance

fees per year

Laos  100 USD

Submission Requirements

17

Submission Requirements Asean Common Technical Dossier (ACTD)Dossier presentation similarities between

ACTD & ICH CTD

18

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

Submission Requirements Major differences between ACTD & ICH CTD

19

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 sections3.2.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

Submission Requirements - Samples

20

Country R/NR Pack (numbers) When

Singapore NR - -

Malaysia NR - -

Indonesia NR - -

Brunei NR - -

Philippines R 2Initial

submission

Vietnam R 2Initial

submission

Thailand R 2 Initial

submission

Cambodia RBased on

therapeutic category

Initial submission

Myanmar RBased on

therapeutic category

Initial submission

Laos RAs per dosage

form Initial

submission

*R: Required; NR: Not required

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

21R: Required; L: Legalized; PIC: Pharmaceutical Inspection Convention

Regulatory Challenges

22

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

23Contd….

Regulatory Challenges

Regulatory Challenges

Specific Requirements:Indonesia: decree 1010 of 2008

Singapore: Proof of API GMP manufacturing facilities & access is required for restricted part of the DMFMalaysia: Planning to implement similar requirement

Thailand: Local bioequivalence study requirement to register new generic drug products

24

Questions & Answers

25

26