Yuppadee JAVROONGRIT, Ph.D.

Transcription

1 Plenary 4- Collaboration & Cooperation among Regulatory Agencies Recent Developments in Cooperation of Regulatory Authorities among ASEAN countries by Yuppadee JAVROONGRIT, Ph.D. Assistant Director, Drug Control Division, FDA, Thailand The 14 th ICDRA Raffles City Convention Centre, Singapore 29 November 2010 Yuppadee-14 th ICDRA 1

2 Topics the ASEAN & cooperation PPWG AWGPD Recommendation Yuppadee-14 th ICDRA 2

3 Topics the ASEAN & cooperation PPWG AWGPD Recommendation Yuppadee-14 th ICDRA 3

4 ASEAN = Association of Southeast Asian Nations - Brunei Darussalam - Cambodia - Indonesia -Lao PDR - Malaysia -Myanmar - Phillippines - Singapore - Thailand -Vietnam established = 8 Aug size ~ 4.5 mil.km 2 total population ~ 580 million Yuppadee-14 th ICDRA 4

5 The ASEAN (1) 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 Yuppadee-14 th ICDRA 5

6 The ASEAN (2) 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 Yuppadee-14 th ICDRA 8Jun2010, Tallinn, Estonia 6

7 The ASEAN- Major Collaboration & Cooperation ASEAN Summit The Leader (Presidents, Prime Minister) - Economic Cooperation-AEM - Political & Security Cooperation - Socio-cultural Cooperation Minister of Economic/Trade Ministry Minister of Foreign Affairs Ministry Yuppadee-14 th ICDRA 7

8 The ASEAN- Major Collaboration & Cooperation ASEAN Summit - Economic Cooperation-AEM - Political & Security Cooperation - Socio-cultural Cooperation Minister of Economic/Trade Ministry The Leader (Presidents, Prime Minister) AFTA AEC Minister of Foreign Affairs Ministry Yuppadee-14 th ICDRA 8

9 The Latest Goal of ASEAN ASEAN Leader Summit ASEAN Economic Community (AEC) by the year ASEAN will be Single Market and Single Production Base Free flow of Goods Free flow of Services Free flow of Investment Free flow of Capitals Free flow of Skilled Labour Yuppadee-14 th ICDRA 9

10 the AEC aim create stable, prosperous, and highly competitive ASEAN Economic region shall establish ASEAN as Single Market and Production base institute new mechanisms and measures to strengthen the implementation of its existing economic initiatives AFTA, AFAS, and AIA accelerate regional integration in the Priority sector improve the Dispute Settlement Mechanism Yuppadee-14 th ICDRA 10

11 The ASEAN- Cooperation ASEAN Summit Economic Cooperation-AEM SEOM ACCSQ WG1 - Mutual Recognition Arrangements (MRAs) & Standards WG2 - Accreditation and Conformity Assessment Sub-WG - Scientific/Industrial Metrology ACC - ASEAN Committee on Cosmetic PPWG - Pharmaceuticals PWG EE PWG- Electrical and Electronic PWG Pf PWG - Prepared Foodstuff PWG TMHS PWG - Traditional Medicine & Health Supplement PWG Medical Devices&Equipment PWG A PWG - Automotives PWG RB PWG - Rubber-based PWG. AFTA AEC - Political & Security Cooperation - Socio-cultural Cooperation AHMM ASCC Council ASOD SOMHD AWGPD ASEAN Working Gr. on Pharmaceuticals Dev. ASEAN Sectoral Working on Traditional Medicine Initiatives on Traditional Medicine Yuppadee-14 th ICDRA 11

12 Topics the ASEAN & cooperation PPWG AWGPD Recommendation Yuppadee-14 th ICDRA 12

13 PPWG ACCSQ/PPWG ASEAN 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!!!! Yuppadee-14 th ICDRA 13

14 PPWG 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) Yuppadee-14 th ICDRA 14

15 Working Scheme of the PPWG Comparative study on Registration Requirement & Regulation Identification the Key Area on Requirements for Harmonization Agreement ACTR, ACTD, Technical guidelines Full implementation timeline ASEAN Sectoral MRA on GMP Inspection Vaccine Chapter Endorsement (ACCSQ / SEOM / AEM / ) the Works - Lead Countries /Members the Meetings Implementation & Capacity Building/Strengthening - Tech. discussion gr. - Dialogue w/ Association - IWG - MRA Task forces - HOD - PPWG Agreement (ASEAN Harmonized Product, MRAs) 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 Yuppadee-14 th ICDRA 15

16 ACTR A set of Written Materials intended to guide applicants to prepare application dossiers in a way that is consistent with the expectations of all ASEAN Drug Regulatory Authorities ACTD The part of marketing authorization application dossier that 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. Yuppadee-14 th ICDRA 16

17 Cooperation PPWG & WHO Vaccine Chapter initiated by Dr.Liliana CHOCARRO (WHO) - aiming to expand benefit of DCVRN for the whole region started in the 10 th 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 17 th 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 Yuppadee-14 th ICDRA 17

18 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 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 ); - on Training project: MedDRA(23-25 Nov.09), Q8-9-10(26-28 Jul.10), and Q5C(on-going) Yuppadee-14 th ICDRA 18

19 Topics the ASEAN & cooperation PPWG AWGPD Recommendation Yuppadee-14 th ICDRA 19

20 Economic Cooperation-AEM The ASEAN- Cooperation ASEAN Summit AFTA AEC ASEAN Strategic Framework on Health Development ASEAN Coop. in Traditional Medicine Coop. with WHO/Dialogue partners - Political & Security Cooperation - Socio-cultural Cooperation AHMM, ASCC Council, ASOD SOMHD AWGPD 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] Yuppadee-14 th ICDRA 20

21 Economic Cooperation-AEM The ASEAN- Cooperation ASEAN Summit AFTA AEC - ASEAN Strategic Framework on Health Development -ASEAN Coop. in Traditional Medicine -Coop. with WHO/Dialogue partners - Political & Security Cooperation - Socio-cultural Cooperation AHMM, ASCC Council, ASOD SOMHD AWGPD 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] Yuppadee-14 th ICDRA 21

22 Activities; The ASEAN- Cooperation ASEAN Summit Training (with supports from APEC-LSIF & ICH-GCG) AFTA AEC Next steps.:- Economic it could Cooperation-AEM be - Political & Security Cooperation follow-up in Implementation of the Training outcome - Socio-cultural Cooperation Regulatory pathway for Clinical Trials/Development on; AHMM, ASCC Council, ASOD - Neglected - ASEAN Diseases Strategic Framework on Health Development SOMHD - Multi-regional Clinical -ASEAN Trial Coop. in Traditional Medicine AWGPD - Pediatric Clinical Trial -Coop. with WHO/Dialogue partners networking for regional assessment for Clinical Trial Application of Pandemic Programme / Multi-national of Good Clinical Manufacturing Trial, Practices with [Id] WHO coordinating/support Standardization, Quality Control and Validation of Herbal Medicine [Id & Th] Programme to Promote Rational Drug Use [Bn & Sg]..(need further discussion/works) 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] Yuppadee-14 th ICDRA 22

23 Topics the ASEAN & cooperation PPWG AWGPD Recommendation Yuppadee-14 th ICDRA 23

24 Experienced from ASEAN Coop. 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 Yuppadee-14 th ICDRA 24

25 Thank You... Together!!! Yuppadee-14 th ICDRA 25