ThaiFDA by Yuppadee JAVROONGRIT, Ph.D. Assistant Director, Drug Control Division, FDA, Thailand The 14 th ICDRA Raffles City Convention Centre, Singapore 29 November 2010 Workshop K-Regulatory functions/marketing “Current Status and Future Perspective for Mutual Recognition in the context of ASEAN Collaboration”
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ThaiFDA
byYuppadee JAVROONGRIT, Ph.D.
Assistant Director, Drug Control Division, FDA, ThailandThe 14th ICDRA
Raffles City Convention Centre, Singapore29 November 2010
Workshop K-Regulatory functions/marketing“Current Status and Future Perspective
for Mutual Recognitionin the context of ASEAN Collaboration”
ThaiFDA
• the ASEAN• collaboration• Mutual Recognition on Pharmaceuticals
Topics
ThaiFDA
• the ASEAN• collaboration• Mutual Recognition on Pharmaceuticals
PPWG - 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.…..Mutual
Recognition
ThaiFDA
ACCSQ/PPWG (1999-now)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”
6. on going tasks ;- MRA – BA/BE Testing- Variation guideline- updating the Technical guidelines : Q, S, E- training activities- new area of harmonization
ThaiFDAMutual Recognition (1)
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)- newly developed ASEAN Quality guidelines;
(1) Analytical Validation guideline(2) BA/BE Studies guideline(3) Process Validation guideline(4) Stability Study guideline
MiV = Minor Variation (variation not affecting 1 or MORE of following aspect: Rt., S/P, Ind., API)GP = Generic Product
Format of ACTR
ThaiFDA
* = upon request
Format of ACTD
Part I
TOCAdmin.data / Product Info.
Part IIQuality
Overall Summary& Report
Part IIINon-Clinical
Overview,Summary,
& Study Report *
Part IVClinical
Overview,Summary,
& Study Report*
ThaiFDA
ACTR - Quality
Drug Substance - General info.- Manufacture - Characterisation- Control of Drug Substance- Ref. Std. or Materials- Container Closure System- Stability
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
- Code of GMP Standards (PIC/S, or equivalence)- Quality System of GMP’s Inspection Unit (PIC/S quality requirement)- GMP Inspection System & Report
• the MRA ;- on Pharmaceuticals Product, not Bio./Radio/CT materials- recognition GMP Certificate & GMP Inspection Report for product registration- on principle “ASEAN+2”- establishment of Joint Sectoral Committee (JSC)
- assessment Competency of GMP Inspection Unit (Gov. org.)- listing the Recognized GMP Inspection Unit (of AMS)
Mutual Recognition (2)MRA– GMP Inspection
ThaiFDA
• starting - 2005• goal - ASEAN Sectoral MRA on BA/BE Studies Report• working area ;
- Comparator product (definition, decision tree, selection, list)- Accreditation of BA/BE Centres (criteria for audit/inspection, certification)- Standards on GCP & GLP- Framework for mutual acceptance of BA/BE Study Report
• the MRA ;- mutual acceptance of BA/BE Study Report
Mutual Recognition (3)MRA– BA/BE Study Report
on going !
ThaiFDA
• to facilitate AFTA & AEC• to eliminate Technical Barrier to Trade (TBT)• to align to International Standards• without compromising on Quality, Safety, Efficacy of