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Yuppadee-14th ICDRA 1

Plenary 4- Collaboration & Cooperation among Regulatory Agencies“Recent Developments in Cooperation of

Regulatory Authorities among ASEAN countries”

byYuppadee JAVROONGRIT, Ph.D.

Assistant Director, Drug Control Division, FDA, ThailandThe 14th ICDRA

Raffles City Convention Centre, Singapore29 November 2010

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• the ASEAN & cooperation• PPWG• AWGPD• Recommendation

Topics

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Topics

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

total population ~ 580 million

- Brunei Darussalam- Cambodia- Indonesia- Lao PDR- Malaysia- Myanmar- Phillippines- Singapore- Thailand- Vietnam

ASEAN = Association of Southeast Asian Nations

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• Objective :(1) accelerate the economic growth, social progress, and

cultural development(2) promote regional peace and stability

• 1995 – ASEAN Leaders reaffirmed that :“Cooperative peace and shared prosperity shall be the Fundamental goals of ASEAN”

The ASEAN (1)

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Yuppadee-14th ICDRA 6Yuppadee – 8Jun2010, Tallinn, Estonia

• Fundamental principle :(i) Mutual respect for the independence, sovereignty, equality

territorial integrity, and national identity of all nations(ii) The right to lead its national existence free from external

interference, subversion, or coercion(iii) Non-interference in the internal affairs of one another(iv) Settlement of differences or disputes by peaceful manner(v) Renunciation of the treat or use of force, (vi) Effective cooperation among themselves

The ASEAN (2)

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The ASEAN- Major Collaboration & Cooperation

ASEAN Summit

- Economic Cooperation-AEM - Political & Security Cooperation- Socio-cultural Cooperation

The Leader (Presidents, Prime Minister)

Minister of Economic/Trade MinistryMinister of Foreign Affairs Ministry

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The ASEAN- Major Collaboration & Cooperation

ASEAN Summit

- Economic Cooperation-AEM - Political & Security Cooperation- Socio-cultural Cooperation

The Leader (Presidents, Prime Minister)

Minister of Economic/Trade MinistryMinister of Foreign Affairs Ministry

AFTAAEC

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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 Latest Goal of ASEAN

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the AECaim create stable, prosperous, and highly competitive

ASEAN Economic region

shall establish ASEAN as Single Market and Production baseinstitute new mechanisms and measures to strengthen

the implementation of its existing economic initiatives –AFTA, AFAS, and AIA

accelerate regional integration in the Priority sectorimprove the Dispute Settlement Mechanism

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The ASEAN- CooperationASEAN Summit

Economic Cooperation-AEM - Political & Security Cooperation- Socio-cultural Cooperation

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

SEOMACCSQ

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

AFTAAEC

AHMMASCC CouncilASODSOMHD

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Topics

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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 !!!!

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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

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Working Scheme of the PPWGComparative study

on 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 /…)

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

Current Activities

• Implementing ASEAN Har.products- for new application - for existing Drug license (by 2012)

• Establishing GMP-MRA JSC• MRA-BA/BE Study Report• Updating Tech.gls.• Variation guideline• New ares of integration: Biological , Biotech.,

Biosimilar product• Facilitating the AEC • Coop. with international forum: WHO, ICH, etc.• Training activities

Agreement• ACTR, ACTD, Technical guidelines• Full implementation timeline• ASEAN Sectoral MRA on GMP Inspection• Vaccine Chapter

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ACTRA set of Written Materials intended to guideapplicants to prepare application dossiers

in a way that is consistent with the expectations of

all ASEAN Drug Regulatory Authorities

ACTDThe part of

marketing authorization application dossierthat is common to all ASEAN member

countries

Technical guidelines• Quality

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

• Safety :- adopted 15 ICH-Safety gls.

• Efficacy- adopted 11 ICH-Efficacy gls.- accepted as Ref.gls. 4 ICH-Efficacy gls.

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Cooperation “PPWG & WHO” – Vaccine Chapter• initiated by Dr.Liliana CHOCARRO (WHO)

- aiming to expand benefit of DCVRN for the whole region• started in the 10th PPWG Meeting (Aug.2005)• focusing in Capacity Building on Vaccine Regulation• Survey on Country’s Need for capacity building on Vaccine CT evaluation/regulation• Main cooperation;

- sharing info. (guidelines, template for regulatory procedures, DCVRN, ….)- invitation to ASEAN members to attend the DCVRN Meeting (s)- regulatory pathway workshop- training courses by WHO/GTN on “Clinical Trial Authorization”, “Clinical Data Evaluation for

Vaccine Registration”, and “GCP Inspection”• The 17th PPWG Meeting (Jul.2010);

- noted the proposal to WHO for continuous support in capacity building efforts related to the vaccine regulation.

- recorded appreciation to WHO and Dr Liliana CHOCARRO for all supports to the ASEAN Member States with regards to the Vaccine Regulatory Framework

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Cooperation “PPWG & ICH” – the GCG

• started from ICH 6(Yr 2003)• invited by ICH to the ICH-GCG Meeting. The PPWG decided to attend

as an Observer, and assigned Co-Chair to be the Rep. since May 2004.• Main cooperation;

- sharing of info. (output from Meetings, on relevant topics, ASEAN profile, ICH website)

- invitation to comment on Step 2 and 4 of ICH-Technical guidelines- utilization and adoption of ICH Technical guidelines- training supports (Speakers)

• the recent Training supports (Yr.2009-11);- on Training project: MedDRA(23-25 Nov.09), Q8-9-10(26-28 Jul.10),

and Q5C(on-going)

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Topics

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AFTAAEC

AHMM, ASCC Council, ASODSOMHDAWGPD

• ASEAN Strategic Framework on Health Development• ASEAN Coop. in Traditional Medicine

• Coop. with WHO/Dialogue partners

• Programme of Good Manufacturing Practices [Id]• Standardization, Quality Control and Validation of Herbal Medicine [Id & Th]• Programme to Promote Rational Drug Use [Bn & Sg]• Collaborating Center for the Production of ASEAN Reference Substances [Th]• Programme for Drug Evaluation [Ph]• Building up and Strengthening ASEAN’s Capacity in GCP and CTs [Th]• ASEAN Collaboration in Combating Counterfeit Drug [Id]• Building up and Strengthening of Pharmacovigilance System in ASEAN [Sg]

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AFTAAEC


- ASEAN Strategic Framework on Health Development-ASEAN Coop. in Traditional Medicine

-Coop. with WHO/Dialogue partners


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AFTAAEC


- ASEAN Strategic Framework on Health Development-ASEAN Coop. in Traditional Medicine

-Coop. with WHO/Dialogue partners


Activities;• Training (with supports from APEC-LSIF & ICH-GCG)

Next steps.:- it could be…• follow-up in Implementation of the Training outcome• Regulatory pathway for Clinical Trials/Development on;

- Neglected Diseases- Multi-regional Clinical Trial- Pediatric Clinical Trial

• networking for “regional assessment for Clinical Trial Application of Pandemic / Multi-national Clinical Trial”, with WHO coordinating/support• …..(need further discussion/works)

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Topics

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• type of strong coop.- the Mutual Agreements- ACTR &ACTD- Technical guideline- MRA

• achievement ;- friendship & trust & supportive- sharing of info. & work- mutual benefit

• essential ;- contribution & commitment- identify & prioritize the Topics/Areas of coop.- keep DRA’s role, while facilitating Leader Mandate/Globalization

Experienced from ASEAN Coop.

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Together !!!Thank You ...

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