ASEAN Cooperation & Harmonization
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1 ASEAN Cooperation & Harmonization by Yuppadee JAVROONGRIT, Ph.D. Co-Chair of ACCSQ/, ASEAN Drug Control Division, FDA, Thailand The ICH-Global Cooperation Group Meeting Westin Michigan Ave. Hotel, Chicago, USA 24 October
2 Outline: ASEAN Cooperation ASEAN Harmonization the 2
3 ASEAN Cooperation 3
4 ASEAN = Association of Southeast Asian Nations Member - Brunei Darussalam - Cambodia - Indonesia -Lao PDR - Malaysia -Myanmar - Phillippines - Singapore - Thailand -Vietnam total population ~ 520 million 4
5 The ASEAN - establishment 8 August population ~ 520 mil. - area 4.5 mil.km 2 - combined gross domestic product 750 mil.usd - total trade 720 mil.usd 5
6 The ASEAN (1) Objective : (i) accelerate the economic growth, social progress, and cultural development (ii) promote regional peace and stability 1995 ASEAN Leaders reaffirmed that : Cooperative peace and shared prosperity shall be the Fundamental goals of ASEAN 6
7 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 7
8 The ASEAN (3) Structure and Mechanisms ASEAN Summit ASEAN Ministerial Meeting Senior Officials Committees Technical Working Groups 8
9 The ASEAN (4) - Major 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 9
10 The ASEAN (5) Economic Cooperation ASEAN Summit AEM HLTF SEOM ACCSQ WGs WG1 on Mutual Recognition Arrangements (MRAs) & Standards WG2 on on Accreditation and Conformity Assessment Scientific/Industrial Metrology Sub-WG PWGs -ACC (ASEAN Committee on Cosmetic) - (Pharmaceutical PWG) - EE PWG (Electrical and Electronic PWG) - Pf PWG (Prepared Foodstuff PWG) -TMHS (Traditional Medicine & Health Supplement PWG) - Medical Devices&Equipment PWG - A PWG (Automotives PWG) - RB PWG (Rubber-based PWG) - WB PWG (Wood-based PWG) 10
11 The ASEAN (6) The AFTA endorsed 1992 purposed to enhance Economic Cooperation strategic objective To increase the ASEAN region s competitive advantage as a single production unit target function tariff, TBT, and NTB 11
12 The ASEAN (7) the AEC (i) the 9 th ASEAN Summit : on 7 Oct. 03 signed the Bali Concord II mandated timeline for AEC to be by the year 2020 endorsed HLTF/ AEM s recommendation :- - improving of the Dispute Settlement Mechanism - establishing 3 new units : Legal unit, ACT, and ACMB(or ACB now) 12
13 The ASEAN (8) the AEC (ii) the Bali Concord II : declared the establishment of ASEAN Community ASEAN Community shall be comprised of 3 pillars :- - political & security cooperation - economic cooperation - socio-cultural cooperation declared the AEC is the realization of the end-goal of economic integration 13
14 The ASEAN (9) the AEC (iii) the AEC : aimed to :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 - implement HLTF s recommendation 14
15 The ASEAN (10) the HLTF (i) establishment by AEM in 2002 the works Recommendations (adopted by AEM & Summit) scope work on 11+1 Priority products -Wood-based - Automotives - Healthcare - e-asean -Rubber-based - Textiles&Apparels - Agro-based -Fisheries - Electronics - Air travel - Tourism - Logistics Pharmaceutical Healthcare sector 15
16 The ASEAN (11) the HLTF (ii) major recommendations on Pharmaceuticals study the feasibility of MRA formalization of a Post-marketing Alert System harmonize a Labeling Std.&Requirement explore the feasibility a flexible Twining System implement ACTD (by 31 Dec. 08) explore the feasibility of adopting a Harmonized Placement system (after ACTD Implementation) 16
17 ASEAN Harmonization The 17
18 The (1) Full name ACCSQ/ ASEAN Consultative Committee for Standards and Quality / Pharmaceutical Product Working Group 18
19 The (2) Establishment 1992 AEM ACCSQ Working Groups (WGs) Product Working Groups (PWGs) 1998 ACCSQ initiated the 1999 ACCSQ endorsed the started to function 2003 & 2005 ACCSQ endorsed 2 nd & 3 rd Term of the (same Chair & Co-Chair countries) 19
20 The (3) 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 20
21 The (4) Principle, Scope, Output Principle to promote Registration, Trade, & Co-operation to eliminate TBT Scope to harmonize ASEAN Pharmaceutical Registration Output ASEAN Harmonized Product (ACTR, ACTD, Glossary of Terms, GLs) 21
22 The (5) Aim & Target for Generic, Modified, and NCEs & Bio. products after achieved ASEAN Harmonized Product Trial Implementation Full Implementation by 31 Dec. 2008! 22
23 The (6) Lead country & Assignment (i) Chair country : Malaysia Co-Chair country : Thailand ACTR : Quality Indonesia Safety Philippines Efficacy Thailand ACTR-Guidelines : Analytical Validation Thailand BA/BE Studies Malaysia Process Validation Singapore Stability Study Indonesia 23
24 The (7) Lead country & Assignment (ii) ACTD : Overall ACTD & ACTD Organization Thailand IWG : Administrative & Glossary Malaysia Quality Indonesia Non-Clinical Philippines Clinical Thailand Singapore (Chair) Indonesia (Co-Chair) MRA-GMP : Singapore / Malaysia (Co-Chairs) MRA-BA/BE: Indonesia / Malaysia (Co-Chairs) 24
25 The (8) Agreement 1. Harmonized Key Areas agreed! 2. Format for ACTR & ACTD agreed! 3. Content of ACTR / ACTD / Glossary of Term agreed! 4. ASEAN Harmonized Products completed! 5. Implementation -Trial period Sep.2003 onwards 6. Full Implementation by 31 Dec
26 The (9) Working Scheme Comparative study on Registration Requirement & Regulation Identification the Key Area on Requirements for Harmonization Assignment Lead Countries Member countries Lead Countries Working The Meeting Agreement ASEAN Harmonized Product Endorsement (ACCSQ / SEOM / AEM / ) Implementation by Members 26
27 The Ultimate 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 AEC year
28 Thank You 28
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