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ASEAN Harmonization
by
Y.J.
ASEAN Harmonization
TFDA
Outline:
International & Asian Pharmaceutical Harmonization ASEAN ACCSQ High Level Task Force (HLTF)HLTF The PPWG PPWG : Agreement / Outcomes PPWG : ASEAN Harmonized Products My Perspective on Global Drug Development & ASEAN
Y.J.
ASEAN Harmonization
Scope - Technical, Guideline, Procedure Coverage - NCEs, Generic, Herbal med.,.. Topic - GMP Inspection, Drug Evaluation,etc
CEE
(Central & Eastern Europe)
WHO
(>190 countries)
ASEAN + 3
(ASEAN,China, Japan,Korea)
PPWG (ASEAN)
PANDRH
(Pan American)
SADC
(South Africa)
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ASEAN
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ASEAN Harmonization
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Symbol of ASEAN
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ASEAN Harmonization
ASEAN
= Association of Southeast Asian Nations Member
- Brunei Darussalam - Cambodia - Indonesia - Lao PDR - Malaysia - Myanmar - Phillippines - Singapore - Thailand - Vietnam
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ASEAN-Major Cooperation
ASEAN Summit
The Leader (Presidents, Prime Minister)
- Economic Cooperation-AEM
Minister of Economic/Trade Ministry
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HLTF
PWGs
-ACC (ASEAN Committee on Cosmetic)
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ASEAN Economic CommunityAEC) by the year 2020.. 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
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year 2015
ASEAN Harmonization
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ACCSQ
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ACCSQ
ASEAN Consultative Committee for Standards and Quality
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- HLTF
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Establishment
AS EAN Summit
AEM
SE M O ACCSQ WGs
WG1 on Mutual Recognition Arrangements (MRA s) & Standards WG2 on on Accreditation and Conformity Assessm ent Scientific and Industrial Metrology Sub-WG
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Objective
To accelerate ASEAN Harmonization towards ASEAN Economic Community for 11 Priority Products now 12 priority products
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The PPWG
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Establishment
ASEAN Summit
AEM
SEOM ACCSQ WGs
WG1 on Mutual Recognition Arrangements (MRAs) & Standards WG2 on on Accreditation and Conformity Assessment Scientific and Industrial Metrology Sub-WG-
HLTF
PWGs
-PPWG (Pharmaceutical PWG)
-ACC (ASEAN Committee on Cosmetic) -EE PWG (Electrical and Electronic PWG) - Pf PWG (Prepared Foodstuff PWG) -TMHD PPWG (Traditional Medicine & Health Supplement PWG) - Medical Devices&Equipment PWG
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PPWG
ACCSQ/PPWG
ASEAN Consultative Committee for Standards and Quality /
TFDA
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Article 2: 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
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Trial Period
Full Implementation
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by Dec. 2008
!
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Agreement :- topics
Agreed ! 1. Harmonized Key Areas Agreed ! 2. Format for ACTR ACTD Agreed !
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Agreement:Guideline to ACTR-Quality
adopted the WHOs GLs adopted the existing International Pharmacopoeias adopted ICH-Quality Guideline (12 GLs) drafted 4 ASEAN Quality GLs
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Agreement:
ASEAN Quality gls
(1) (2) (3) (4)
Analytical Validation guideline BA/BE Studies guideline Process Validation guideline Stability Study guideline
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Agreement:Guideline to ACTR-Safety
adopted ICH-Safety guideline (15 GLs)
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Agreement:Guideline to ACTR-Efficacy
adopted 11 GLs (E1, E2A, E2C, E3, E4, E6-E11) accepted as Ref.gl. 4 gls (E2C(A), E2D, E2E, E12A) not adopted 2 gls (E2B(M), E5)
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Agreement :- topics
1. 2. 3. 4.
Agreed ! Harmonized Key Areas Agreed ! Format for ACTR ACTD Content of ACTR / ACTD / Glossary of Term Guidelines to ACTR Agreed !
Agreed !
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Agreement :- topics
1. Harmonized Key Areas Agreed ! Agreed ! 2. Format for ACTR ACTD 3. Content of ACTR / ACTD / Glossary of Term Agreed ! Agreed ! 4. Guidelines to ACTR 5. Implementation -Trial period
Sep. 2003 onwards
6. Full Implementation
by 31 Dec. 2008
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PPWG
ASEAN Harmonized Products
ACTR / ACTD / Glossary of Term / GLs
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ACTR Format
Requirement No. Parameter Components
NCE Bio. Rt. MaV MiV S/P Ind. GP
Note:
NCE = New Chemical Entity Bio. = Biotechnological product MaV = Major Variation (variation affecting 1 or MORE of following aspect: Rt., S/P, Ind., or other Non-MiV) Rt. = Route of Adminstrative S/P = Strength & Posology Ind. = Indication MiV = Minor Variation (variation not affecting 1 or MORE of following aspect: Rt., S/P, Ind., API) GP = Generic Product
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Content of ACTR
ACTR - Quality
Drug Substance
General info. Manufacture Characterisation Control of Drug Substance Ref. Std. or Materials Container Closure System Stability
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Drug Product
Description and Composition Pharmaceutical Development Manufacture Control of Excipients Control of Finished Product Ref. Std. or Material Container Closure System Stability Product Interchangeability/Equivalence evidence
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Content of ACTR
ACTR - Safety
Pharmacology
Primary Pdynamics Secondary Pdynamics Safety Pcology Pdynamic Drug Interaction Absorption Distribution Metabolism (inter-species comparison) Excretion Pcokinetic Drug Interaction(Non-clinical) Other Pcokinetic Studies
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Toxicology
Single Dose Toxicity Repeat Dose Toxicity Genotoxicity Carcinogenicity Reproductive & Development Toxicity
Pharmacokinetics
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Content of ACTR
ACTR - Clinical Data
BA & BE Studies
- BA Studies - Comparative BA or BE Studies
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ACTD Organization
Part I
TOC Admin.data / Product Info.
* = upon request
Part IV
Clinical
Overview, Summary, & Study Report*
Non-Clinical
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Content of ACTD
Part 1: ToC Admin.Data&Product Info. Section A: Introduction Section B: Overall ACTD-ToC Section C: Doc. Required for Registration Part 2 : Quality Document Section A: ToC Section B: Quality Overall Summary Section C: Body of Data Part 3 : Non-clinical / Safety Document Section A: ToC Section B: Non-clinical Overview Section C: Non-clinical Written & Tabulated Summaries Section D: Non-clinical Study Reports*
Note: ToC = Table of Content * = Upon REQUEST Y.J.
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Content of ACTD
Part I: Administrative Data & Product Information
Application Form Letter of Authorisation Certification Labeling Product Information Language
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My Perspective
on Global Drug Development & ASEAN
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My Perspective on :
Global Drug Development & ASEAN
Standards & Requirement to be a Player Advantage to NDA Approval & Access to Medicine of Patients Affordable ? Individual vs. Regional? Impact ?
Pharmaceutical Registration ASEAN Framework Agreement on Product Integration ASEAN Economic Community (AEC)
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Thank You
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Myself :
Name : Yuppadee Javroongrit, Ph.D. Education :
B.S. in Pharmacy-Thailand (Major-Cosmetic) M.S. in Industrial Pharmacy- USA
(Evaluation of Calcium Polycarbophil As a Disintegration Agent in Direct Compression Tableting)
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Abbreviation :
ACCSQ = ASEAN Consultative Committee for Standards and Quality ACTD = ASEAN Common Technical Dossier ACTR = ASEAN Common Technical Requirement DRA = Drug Regulatory Authority GLs IWG = Guidelines = Implementation Working Group
MRAs = Mutual Recognition Arrangements PPWG = Pharmaceutical Product Working Group NTB = Non Tariff Barrier TBT = Technical Barrier to Trade
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Abbreviation on ASEAN
ACCSQ AEC AEM AFAS AFTA AIA AICO HLTF PPWG MRA SEOM = ASEAN Consultative Committee for Standards and Quality = ASEAN Economic Community = ASEAN Economic Ministers = ASEAN Framework Agreement on Services = ASEAN Free Trade Area = ASEAN Investment Area = ASEAN Industrial Cooperation Scheme = High Level Task Force = Pharmaceutical Product Working Group = Mutual Recognition Arrangement = Senior Economic Officials Meeting
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