ASEAN-PPWG

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byYuppadee JAVROONGRIT, Ph.D.

Co-Chair of ACCSQ/PPWG, ASEANThaiFDA, Thailand

The ICH-Global Cooperation Group MeetingHilton Fukuoka Sea Hawk Hotel, Fukuoka, JAPAN

05 June 2012

Regional Update – ASEAN PPWG

ASEAN-PPWG

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The AEC & PPWG

ASEAN-PPWG

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ASEAN = Association of Southeast Asian Nations

established = 8 Aug. 1967size ~ 4.5 mil.Km2

total population ~ 590 millionGDP (2010)~ 1,865 bill.USD

ASEAN-PPWG

ASEANEconomic

Community(AEC)

ASEANSocio-culturalCommunity(ASCC)

ASEAN Political-Security

Community(APSC)

ASEAN Community

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A.D.2003 A.D.2015

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ASEAN-PPWG

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ASEAN Leader Summit

ASEAN Economic Community (AEC)“by the year 2015….. ASEAN will be

Single Market and Single Production BaseFree flow of GoodsFree flow of ServicesFree flow of InvestmentFree flow of CapitalsFree flow of Skilled Labour

The Goal on Economic

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The ASEAN- Cooperation “Pharmaceuticals”ASEAN Summit

Economic Cooperation - Political - security Cooperation- Socio-cultural Cooperation

WG1 - Mutual Recognition Arrangements (MRAs) & StandardsWG2 - Accreditation and Conformity Assessment WG3 - Scientific/Industrial Metrology

AEMSEOMACCSQ

ACC - ASEAN Committee on CosmeticPPWG - Pharmaceuticals PWGEE PWG- Electrical and Electronic PWGPf PWG - Prepared Foodstuff PWGTMHS PWG - Traditional Medicine & Health Supplement PWGMedical Devices&Equipment PWGA PWG - Automotives PWGRB PWG - Rubber-based PWG…….

AWGPD – ASEAN Working Gr. on Pharmaceuticals Dev.ASEAN Sectoral Working on Traditional MedicineInitiatives on Traditional Medicine

AHMMASCC CouncilASODSOMHD

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AEC – the Measures

• ASEAN Charter • AEC Blueprint• AEC Scorecard• ASEAN Good Regulatory Practice (GRP)• ASEAN Trade Facilitation Work Programme• ASEAN Trade in Goods Agreement (ATIGA)

Leader’s Mandate

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PPWG ACCSQ/PPWGASEAN Consultative Committee for Standards and Quality /

Pharmaceutical Product Working Group

Objective:to develop harmonization scheme of Pharmaceuticals regulations of the ASEAN member countries, to complement and facilitate the objective of AFTA, particularly, the elimination of Technical Barriers to Trade posed by the regulations, without compromising on drug quality, efficacy, and safety”

& facilitate the AEC !!!!

ASEAN-PPWG

• 1992 AEM ACCSQWorking Groups (WGs)

• 1998 ACCSQ initiated the PPWG

PPWG started to function

Product Working Groups (PWGs)

• 1999 ACCSQ endorsed the PPWG

• 2003, 2005, 2009 & 2011ACCSQ endorsed “2nd, 3rd, 4th & 5th Term of the PPWG”

(same Chair & Co-Chair countries)

The PPWG – Establishment

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Principle to promote “Registration”, “Trade”, & “Co-operation”to eliminate “TBT”

Scope to harmonize “ASEAN Pharmaceutical Registration”

Output ASEAN Harmonized Product (ACTR, ACTD, guidelines)

Mutual Recognition Agreement (MRA)

PPWG

ASEAN-PPWG

BA/BE Studies Malaysia

• ACTR : Quality IndonesiaSafety PhilippinesEfficacy Thailand

• ACTR-Guidelines : Analytical Validation Thailand

Process Validation SingaporeStability Study Indonesia

Chair country : MalaysiaCo-Chair country : Thailand

The PPWG– Lead country & Assignment (1)

ASEAN-PPWG

Administrative & Glossary Malaysia• ACTD : Overall ACTD & ACTD Organization Thailand

Quality Indonesia

Clinical /Efficacy Thailand

Non-Clinical Philippines

• IWG :Indonesia (Co-Chair)Singapore (Chair)

• MRA-BA/BE: Indonesia / Malaysia (Co-Chairs)

• MRA-GMP : Singapore / Malaysia (Co-Chairs)

• Post-marketing Alert System (PMAS): Singapore / Malaysia

The PPWG– Lead country & Assignment (2)

• Biologics coop. Indonesia / Singapore

ASEAN-PPWG

• to facilitate AFTA & AEC• to eliminate Technical Barrier to Trade (TBT)• to align to International Standards• without compromising on Quality, Safety, Efficacy of

Pharmaceuticals

The PPWG– Recognition & Agreement

Product License

the Decisionof individual Member Country

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ASEAN-PPWG

Agreed “ACTR, ACTD, Technical guidelines”

• ACTR (ASEAN Common Technical Requirement)• ACTD (ASEAN Common Technical Dossier)• Technical “Quality, Safety, Efficacy” guidelines -

- adopted guidelines (from WHO, ICH, and International pharmacopoeia)- developed ASEAN Quality guidelines;

(1) Analytical Validation guideline(2) BA/BE Studies guideline(3) Process Validation guideline(4) Stability Study guideline

ASEAN-PPWG

adopted 15 ICH-Safety gl.

S&E Technical guidelineGuideline - Safety

Guideline - Efficacy

adopted 11 ICH-Efficacy gl. (E1, E2A, E2C, E3, E4, E6-11)

accepted as Ref.gl. 4 ICH-Efficacy gl. (E2C(A), E2D, E2E, E12A)

ASEAN-PPWG

S1A Guideline on the Need for Carcinogenicity Studies of PharmaceuticalsS1B Testing for Carcinogenicity of PharmaceuticalsS1C Dose Selection for Carcinogenicity Studies of PharmaceuticalsS1C(R) Addendum to SIC: Addition of a Limit Dose and Related NotesS2A Guidance on Specific Aspects of Regulatory Tests for PharmaceuticalsS2B Genotoxicity : A Standard Battery for Genotoxicity Testing for PharmaceuticalsS3A Note for Guidance on Toxicokinetics: the Assessment of Systemic Exposure in Toxicity StudiesS3B Pharmacokinetics : Guidance for Repeated Dose Tissue Distribution StudiesS4 Single Dose Toxicity TestsS4A Duration of Chronic Toxicity Testing in Animals (Rodent and Non-Rodent Toxicity Testing)S5A Detection of Toxicity to Reproduction for Medicinal ProductsS5B(M) Maintenance of the ICH Guideline on Toxicity to Male Fertility : An Addendum to

the Guideline on Detection of Toxicity to Reproduction for Medicinal ProductsS6 Safety Studies for Biotechnological ProductsS7A Safety Pharmacology Studies for Human PharmaceuticalsM3 Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals

adopted ICH-S gls :Technical Guideline to ACTR

ASEAN-PPWG

E1 The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions

E2A Clinical Safety Data Management: Definitions and Standards for Expedited ReportingE2C Clinical Safety Data Management : Periodic Safety Update Reports for Marketed DrugE3 Structure and Content of Clinical Study ReportsE4 Dose-Response Information to Support Drug RegistrationE6 Good Clinical Practice: Consolidated GuidelineE7 Studies in Support of Special Populations : GeriatricsE8 General Considerations for Clinical TrialsE9 Statistical Principles for Clinical TrialsE10 Choice of Control Group and Related Issues in Clinical TrialsE11 Clinical Investigation of Medicinal Products in the Pediatric Population

adopted ICH-E gls :Technical Guideline to ACTR

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Comparative studyon Registration Requirement & Regulation

Agreement(ASEAN Harmonized Product, MRAs)

Identification the “Key Area on Requirements”for Harmonization

the Works -“Lead Countries”/Members

the Meetings

Implementation Capacity Building/Strengthening

Endorsement (ACCSQ / SEOM / AEM /…)

Working Scheme of the PPWG

- Tech. discussion gr.- Dialogue w/ Association - IWG- MRA Task forces - HOD- PPWG

Activities of PPWG(1) Implementing ASEAN Harmonized

products- for new application - for existing Drug license (by 2012)

(2) Establishing GMP-MRA JSC(3) BA/BE MRA(4) Updating Tech.gls.(5) New areas of integration: Biological ,

Biotech., Biosimilar product(6) Facilitating the AEC(7) Coop.with international forum:

WHO, ICH, etc.

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Vietnam’s Training Request

ASEAN-PPWG

• Submission via email on Sep.2, 2011 to PPWG’s Co-chair, cc ICH Sec.• GCG-Nov.2011 :

• no Rep.ASEAN attended (flooding emergency problem)• GCG suggested waiting for ASEAN discussion/decision

• VN&ASEAN discussion : • VN-DAV does not retain any more the request on training • …….

The Request & Decision

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ASEAN agree to drop VN training request !

ASEAN-PPWG

seeks advise, if any further Duplication Requests….

GCG’s Training Criteria !

ASEAN Procedure “Training Request”

• 3 mths. in advance• Country send request, using ICH-GCG

form, to the PPWG’s Chair or Co-chair• need approval from the PPWG’s Chair• once approval, the Request will be

processed and submitted to the ICH-GCG by PPWG’s Co-Chair

GCG to take note !

DuplicationTraining need w/in RHI

GCG to confirm the criteria !

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The 19th PPWG Meeting

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Date Morning (09.00-12.30h) Lunch Afternoon (14.00-17.00h)Day 1- Monday

(2 July 2012)Seminar (for all) 9:00-12:30h: “Quality by Design (QbD) Forum for ASEAN

Regulators- (ICH Q8/Q9/Q10/Q11)”

Continuation of Seminar 13:30-15:40h: “Quality by Design (QbD) Forum for ASEAN

Regulators- (Q8-Q9-Q10)” (con’t)15.40-16.00 h Break16:00- 17:00h: “The Biosimilar Regulation: Rationale and

Regulatory Requirements”

Day 2- Tuesday(3 July 2012)

Technical Working Group (for all) • Q& A on ACTR/ACTD Quality & Guidelines

- Analytical Validation guidelines - Process Validation guidelines- ACTR & ACTD quality- Stability guidelines- Variation guidelines

• Q& A on ACTR/ACTD - Safety+ Efficacy & Guidelines • BA/BE Technical Guidelines • Biological Working Group

The Taskforce (only for DRA)• GMP Taskforce - MRA /JSC

Continuation of Technical Working group

Continuation of The Taskforce (only for DRA)

Special Meeting17.00-21.00h: HOD Meeting & Working Dinner

Day 3-Wednesday

(4 July 2012)

IWG Meeting (for all)

The Taskforces (only for DRA)• GMP Taskforce - MRA /JSC• BA/BE Taskforce - MRA

***Opening Ceremony*** of The 19th ACCSQ-PPWG Meeting

The 19th ACCSQ-PPWG Meeting (continue)

Day 4-Thursday(5 July 2012)

Continuation of The 19th ACCSQ-PPWG Meeting Continuation of The 19th ACCSQ-PPWG Meeting

18.00-22.00h: Welcome Dinner to ALLDay 5-Friday(6 July 2012)

Visiting Trip (only for foreigners)• Visit BE Centers • Visit local Manufacturers (only for DRA)

Adoption of the Report 19th ACCSQ-PPWG Meeting

The Overall Program for The 19th ACCSQ-PPWG Meeting (2-6 July 2012, Siam City Hotel Bangkok, Thailand) (as of 28 May 2012)

ASEAN-PPWG

http://www.19thaccsq-ppwg.org/2012/home.php

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ASEAN-PPWG

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Thank You