WORK PROGRAMME OF THE ACCSQ
PRODUCT WORKING GROUP ON PHARMACEUTICAL
GOAL	STRATEGY		ACTIVITIES		EXPECTED OUTPUT		TIME FRAME	COUNTRY RESPONSIBLE	STATUS OF IMPLEMENTATION
Harmonization of ASEAN Pharmaceutical Regulations	1.	To compare existing product registration requirements for pharmaceuticals of ASEAN member countries	1.1	Formation of a study group.	1.1	Study group formed	Sept. 1999	Malaysia (Lead country)	Report on Comparative Study on Product Registration for Pharmaceuticals of ASEAN Member Countries presented at the 2nd PWP-P Meeting on 5 March 2000
			1.2	To conduct comparative studies through surveys, questionnaires, analysis and workshops*, identify and prioritise  harmonized key areas	1.2	Report on the comparative studies defining similarities and differences.		Philippines
			1.3	Circulation of report finding to ASEAN member countries for comments	1.3	Report circulated to ASEAN member countries		* (pending on the availability of funding from ASEAN Secretariat)
			1.4	Presentation for approval of proposal on harmonized key areas to the product working group on pharmaceuticals	1.4	Proposal for harmonized key areas for common technical requirement	31-Dec-99
	2.	To develop common technical requirements for pharmaceutical product registration for ASEAN	a.	Setting of Ad-Hoc Committees to study on key areas of technical documents submitted for registration to be in line with ICH/WHO guidelines.	2.1	Drafts of harmonized technical requirements/ guidelines of the identified areas	Jan 2000 – June 2001
				Areas of concern expected to be obtained from 1.2 may include:
			i.	Pharmaceutics (Quality)	-	Responsible countries to submit preliminary documents to Indonesia	Jun. 2000	Indonesia (Lead country) Thailand, Philippines, Malaysia, Singapore, Vietnam, Brunei Darussalam	·   Received preliminary       doc. From responsible       countries.
			-	GMP Requirement (Indonesia)
					-	Indonesia to compile preliminary documents & send draft proposal to members for comments (Draft 1)	Sept. 2000
			-	Analytical Procedures Validation
				(Philippines)
									·      Compiling the preliminary       doc.  and preparing the       Draft 1 to send to members       for comments.
			-	Process Validation
				(Singapore)	-	Members feedback	Nov. 2000
			-	Stability Studies (Thailand)	-	Indonesia to prepare final Common Technical Requirements (CTR) on Pharmaceutics (Quality) based on feedback (Draft 2)	Nov. 2000
			-	Bioequivalence Studies & Interchangeability (Malaysia)
									·       Proposed CTR already       been made and subject to       reformatting
					-	Proposed CTR on Pharmaceutics (Quality) to be presented for adoption	4thP-PWG meeting
					-	Adoption of CTR on Pharmaceutics (Quality)	4th P-PWG meeting
			ii.	Pharmacological and Toxicological Data (Safety - Pre-Clinical Study)	-	Questionnaire on defined areas distributed to members	Mar. 2000	Philippines (Lead country) Lao PDR, Thailand	·       Draft 1 circulated to       members for comments.
			-	S1 – Carcinogenicity	-	Members to submit completed questionnaire to Philippines	Jun. 2000
			-	S2 – Genotoxicity
			-	S3 – Kinetics
			-	S4 – Toxicity	-	Philippines to compile feedback & send draft proposal to members for comments (Draft 1)	Aug. 2000
			-	S5 – Reprotox
			-	S6 – Biotech safety
			-	S7 – Pharmacology
			-	M – Multidisciplinary
					-	Members feedback	Oct. 2000
					-	Philippines to prepare final CTR on Safety based on feedback  (Draft 2)
					-	Proposed CTR on Safety to be presented for adoption	4th P-PWG meeting (Sept 2001)
					-	Adoption of CTR on Safety	4th P-PWG meeting (Sept 2001)
			i.	Clinical  Data
					-	Thailand to circulate draft  proposal to members (Draft 1)	Jul-00	Thailand (Lead country) Malaysia, Philippines, Singapore, Cambodia, Lao PDR, Viet Nam	·       Draft 1 circulated to       members for comments.
			A.	Table of Contents of Clinical Study and Related Information
			B.	Tabular Listing of all Clinical Studies	-	Members feedback	Sep. 2000
			C.	Clinical Study Report
				-    Executive Summary Report	-	Thailand to prepare proposal on Clinical Trial Data based on feedback (Draft 2)	Feb. 2001
				-    Report of Bioavailability (BA) &     Bioequivalence (BE) Studies
				-    Reports of Studies using Human     Biomaterial pertinent to absportion     or disposition
					-	Proposed CTR on Clinical Trial Data to be presented for adoption	4th P-PWG meeting (Sept 2001)
				-    Reports of Human Pharmacokinetic     (PK) Studies
				-    Reports of Efficacy & Safety     Studies	-	Adoption of CTR on Clinical Data	4th P-PWG meeting (Sept 2001)
				-    Reports of Human     Pharmacodynamic (PD) Studies
				-    Reports of Post-Marketing     Experience
				-    Published and Unpublished Papers
			ii.	Administrative Data
			-	Certificate of Pharmaceutical Product (CPP)	-	Malaysia to circulate draft proposal to members (Draft 1)	Jun-00	Malaysia (Lead country)	·       Draft 1 circulated to       members for comments.
			-	Letter of Authorisation (LOA)				Philippines, Thailand, Myanmar
			-	Labelling	-	Members feedback	Aug. 2000
			-	Patient Information Leaflet (PIL)
			-	Summary of Product Characteristics (SPC)	-	Malaysia to prepare final CTR on  Administrative Data based on feedback (Draft 2)			·      To receive feedback from      members by end of August      2000.
			-	Draft/Proposed Label
			-	Patent/Trademark Evidence
			-	Language	-	Proposed CTD on Administrative Data to be presented for adoption	4th P-PWG meeting (Sept 2001)
			-	Application Form
					-	Adoption of CTD on Administrative Data	4th P-PWG meeting (Sept 2001)
			2.1.5	Glossary of terms	Draft glossary circulated to ASEAN member countries		Mar. 2001	Malaysia
			2.2	Circulation of draft of complete Common Technical Requirements (CTR) to ASEAN member countries for comments	-	Draft circulated to ASEAN member countries	Jul. 2001	Thailand	Thailand to coordinate all feedbacks and submit to 4th PWG-P meeting
			2.3	Presentation for approval of the final draft to product working group on pharmaceuticals.	-	Proposal for Common Technical Requirements (CTR)	4th P-PWG meeting (Sept 2001)
	3.	To develop common technical dossier for Pharmaceu-tical Product Registration for ASEAN with a view of arriving at MRAs	3.1	Drafting of ASEAN common technical dossier (CTD) for pharmaceutical product registration	-	Draft of ASEAN common technical dossier for pharmaceutical product registration	4TH P-PWG   meeting (Sept 2001)	Thailand (Lead country) Philippines Indonesia Singapore, Malaysia
					-	CTD for administrative Data
					-	CTD for Pharmaceutics (Quality)		Indonesia
					-	CTD for Pharmacolo gical and Toxicological data (Safety)		Philippines
					-	CTD for Clinical Data		Thailand
			3.2	Circulation of draft CTD to ASEAN member countries for comments.	-	Draft dossier circulated to ASEAN member countries	Feb. 2002
			3.3	Compilation of feedback on draft CTD from the ASEAN member countries.	-	Feedback from ASEAN member countries compiled	May-02
			3.4	Finalising the draft CTD for Product Registration Application.	-	Draft dossier finalised	Sep. 2002
			3.5	Presentation of final draft of dossier to Product Working Group on Pharmaceuticals for approval	-	Proposal of common technical dossier for ASEAN member countries	Dec-02
			3.6	Submission of harmonized ASEAN dossier to ACCSQ for endorsement
	4.	To implement the harmonized ASEAN pharmaceutical product dossier	4.1	Setting of Working Group to organize, coordinate and monitor the implementation of the ASEAN CTD	-	Implementation of  ASEAN CTD