Part I - Completed Activities of Accsq Work Programme

WORK PROGRAMME OF ASEAN CONSULTATIVE COMMITTEE ON STANDARDS AND QUALITY STARTING FROM OCTOBER 2003

AREA ACTIVITIES REFERENCE/ ACTIVITIES IN EXPECTED OUTPUT TIME FRAME RESPONSIBLE STATUS OF DETAIL MEMBER/WG/PWG IMPLEMENTATION

ACCSQ either implements or monitors the implementation by its Working Groups and Product Working Groups for the following areas:

I. Mutual 1.1. Implementation of Recognition Identified sectoral Arrangements MRAs:

Electrical and Joint Sectoral EE All member countries have Electronic: MRA notified their participation Refer to ANNEX 1 for details - Successful implementation 2005 in either acceptance of 1.1.1 Implementation of of ASEAN EE MRA; test report and/or product the ASEAN EE MRA certification

Singapore and Thailand has submitted their proposed designated CABs during the 4th JSC EE MRA Meeting for consideration by 18 August 2004.

Cosmetics:

1.1.3 Preparation and Refer to ANNEX 2 for details Successful implementation 2008 Cosmetic Product The Agreement on implementation of ASEAN of ASEAN Harmonized Working Group and ASEAN Harmonized Harmonized Cosmetic Cosmetic Regulatory ASEAN Cosmetic Cosmetic Regulatory Regulatory Scheme Committee Scheme signed on 2 September 2003

Nine member countries submitted their notification to participate in Schedule A/B. Member Countries except Myanmar and Viet Nam confirmed their readiness to participate in ASEAN Cosmetic Directive by 2008 (Singapore may start earlier than 2008)

of 44 AREA ACTIVITIES REFERENCE/ ACTIVITIES IN EXPECTED OUTPUT TIME FRAME RESPONSIBLE STATUS OF DETAIL MEMBER/WG/PWG IMPLEMENTATION Pharmaceuticals:

1.1.4 Implementation of Refer to ANNEX 3 for details MRAs for Pharmaceutical 1 Jan 2009 Member countries - Member countries plan the ASEAN Common sector developed and to fully implement the Technical Dossiers implemented. ACTD as follows: (ATCD) and ASEAN - Singapore (Jan 2005) Common Technical - Malaysia & Thailand Requirements (ATCR) ; (Dec 2005) - Viet Nam (Jan 2006) 1.1.5 Possible MRAs for - Brunei & Philippines Pharmaceutical Sector (Dec 2006) - Indonesia (Dec 2007) - Cambodia, Lao PDR, Myanmar (Dec 2008)

Areas have been identified for exploration of possible MRAs.

Prepared Foodstuff: Approaches to develop 1.1.6. Possible ASEAN Refer to ANNEX 4 for details MRAs for prepared foodstuff September 2003 Prepared Foodstuff MRA being considered Harmonized Prepared sector developed and onward Product Working Foodstuff Regulatory implemented Group Scheme

1.1.7. Possible MRAs for Prepared Foodstuff Sector

1.2. Monitor and support Refer to ANNEX 5 for details On-going MRAs and the implementation of the Standards WG ASEAN Sectoral MRAs (WG1)

1.2.1. Promotion of Good Technical regulations October 2003 MRAs and Ongoing dissemination Regulatory Practice developed that allow MRAs onward Standards WG and exchange of (GRP) among regulators be implemented (WG1) information

1.2.2. Provide guideline or On- going MRAs and assistance to PWGs Standards WG during the development (WG1) and implementation of any MRAs

1.3 Identification and Refer to ANNEX 5 for details New areas for MRAs April 2004 ACCSQ recommendation of new identified areas for possible MRAs

of 44 AREA ACTIVITIES REFERENCE/ ACTIVITIES IN EXPECTED OUTPUT TIME FRAME RESPONSIBLE STATUS OF DETAIL MEMBER/WG/PWG IMPLEMENTATION 2. Standardization 2.1 Harmonization of standards

2.1.1 Monitor harmonized Member countries All member countries standards for 20 priority MRAs and completed the products Refer to ANNEX 5 for details Harmonization of standards ongoing Standards WG harmonization work. be ensured (WG1) Assessment on the use of harmonized standards being conducted

2.1.2. Harmonization of Refer to ANNEX 5 for details 72 safety and EMC 2004 Member countries All member countries standards for additional standards harmonized in and MRAs and completed the safety and EMC standards ASEAN Standards WG harmonization work (WG1)

2.1.3 Identification and 2.1.3.1. Identification and New areas identified for October 2003 Member countries Survey is being conducted endorsement of new recommendation of new areas for harmonization onward and MRAs and with Malaysia as lead areas for harmonization of harmonization of standards. Standards WG country. standards (WG1)

2.1.3.2 Endorsement of new areas for ACCSQ harmonization of standards

2.1.3.3. Harmonization of standards Member countries by member countries

2.2. Cooperation for international standardization activities

2.2.1 Recommending to Recommendations for October 2003 Member countries the ACCSQ proposals, consideration by ACCSQ onward and MRAs and activities or issues for Standards WG ASEAN cooperation in the (WG1) framework of ISO, IEC, APEC and ASEM.

2.2.2 Strengthen ASEAN 2.2.2.1 Proposal or recommendations Common ASEAN position at October 2003 ACCSQ ACCSQ consider meeting position in international to be considered by the relevant international standardization onward with the ISO Secretary standardization international standardization organizations General to strengthen ties organizations (ISO, organizations and cooperation APEC, ASEM, IEC ect.)

3. Accreditation 3.1. Examining the Refer to ANNEX 6 for details Member countries to meet On- going WG2 Project Under AADCP international and regional the requirements accreditation bodies’ established by relevant recognition requirements international accreditation and assisting member organizations

of 44 AREA ACTIVITIES REFERENCE/ ACTIVITIES IN EXPECTED OUTPUT TIME FRAME RESPONSIBLE STATUS OF DETAIL MEMBER/WG/PWG IMPLEMENTATION countries in meeting these requirements

3.2 Supports to promote 3.5.1 Recommendation and August 2004 WG2 the accreditation system elaboration on peer evaluation onwards in Member Countries 3.5.2 Implementation of peer WG2 evaluation

3.3. Strengthen Refer to ANNEX 6 for details On-going WG2 Project under AADCP competence of ASEAN Laboratories; product and quality system certification bodies

3.4. Measures toward 3.3.1. Recommendation of measure October 2003 WG2 “One standards, One test, for consideration by the ACCSQ onwards Accepted in ASEAN” 3.3.2. Endorsement of ACCSQ recommendations for implementation by member countries

3.3.3 Member countries to implement Member countries the recommendations

3.5 Coordination 3.4.1 Recommendation of Coordination Mechanism August 2004 WG2 24th ACCSQ endorsed the mechanism between WG2 mechanism coordination mechanism and other WGs/PWGs to support integration of 11 priority sectors 3.4.2 WGs/PWGs to implement August 2004 ACCSQ mechanism onwards WGs/PWGS

4. Metrology 4.1. Legal metrology

4.1.1. Harmonization of Refer to ANNEX 7 for details Common requirements for On- Going WG3 (former WG5) ASEAN Common legal metrology legislation legal metrology in ASEAN Requiremetns for Pre and administration Packaged Goods adopted at the 4th Sub WG on Legal Metrology Meeting

Areas identified for harmonization of legal metrology and administration

of 44 AREA ACTIVITIES REFERENCE/ ACTIVITIES IN EXPECTED OUTPUT TIME FRAME RESPONSIBLE STATUS OF DETAIL MEMBER/WG/PWG IMPLEMENTATION 4.2. Scientific Metrology 4.2.1 Identification and Nov. 2003 WG3 (former WG5) Sub WG on Scientific recommendation of activities for onward Metrology to be cooperation in ASEAN on scientific established legal metrology.

4.2.2. Endorsement of ACCSQ recommendations for implementation

5. Transparency 5.1 Transparency of 5.1.1. Member countries/ WGs/ Technical regulations, On-going Indonesia as the technical regulations, PWGs to make available technical standards and conformity lead countries in standards and conformity regulations, standards and conformity assessment regimes applied cooperation with assessment regimes assessment regimes for reference by by member countries are Chairs of WGs and among member countries interested parties. Measures would accessible by interested PWGs and member include posting information on parties countries. national website and ASEAN website

5.2.2 Regular publication of ASEAN Indonesia in Bulletin on Standards and Quality collaboration with the ASEAN Secretariat and Malaysia

6 Technical 6.1. Possible 5.1.1. Study Possible harmonization Technical regulations and 2003 onwards - JSC EE MRA 4th JSC EE MRA adopted Regulations and harmonization of technical of technical regulations and conformity assessment - CPWG/ ACA the roadmap for conformity regulations/ conformity conformity assessment regimes in procedures for priority - PPWG harmonization of EE assessment assessment regimes in ASEAN for priority areas: sectors harmonized among - PFPWG Regulatory regime regimes some selected sectors member countries Electrical and electronic; ASEAN Cosmetic Cosmetics; Harmonized Regulatory Pharmaceuticals; Regime to be Prepared Foodstuff implemented by 2008

7. Enhancement of 7.1. Implementation of 7.1.1. Possible assistance for CLMV On-going ACCSQ/ member Various projects being technical Initiative for ASEAN by other member countries. countries implemented infrastructure Integration

8. New Initiative for 8.1. Follow-up actions on 8.1.1. Study recommendations given Possible elimination of 2003 onwards WG1 24th ACCSQ Meeting ASEAN Economic standards and by HLTF pertaining to standards and technical barrier to trades for endorsed the Integration conformance for 11 conformance for 11 priority sectors. 11 priority sectors recommendations on priority sectors given by standards and AEM in September 2003 conformance for SEOM consideration

of 44 AREA ACTIVITIES REFERENCE/ ACTIVITIES IN EXPECTED OUTPUT TIME FRAME RESPONSIBLE STATUS OF DETAIL MEMBER/WG/PWG IMPLEMENTATION 8.1.2. Recommendations for WG1 consideration by the ACCSQ. Recommendations include possible harmonization of standards and MRAs;

8.1.3 Finalization of the roadmap for 2004 ACCSQ and Roadmap finalized during integration on standards and member countries the 24th ACCSQ Meeting conformance

8.1.4 Implementation of roadmap for August 2004 - ACCSQ 24th ACCSQ agreed to integration on standards and onwards establish: conformance . PWG on Automotive . PWG on Traditional Medicine and Health Supplement . PWG on Medical Device . PWG on Rubber- based . PWG on Wood-based

8.1.5 Development on ASEAN policy ASEAN policy on Standards August 2004 - ACCSQ 1st draft discussed during on standards and conformance and Conformance onwards the 24th ACCSQ Meeting

9. Cooperation with 9.1. Cooperation with 9.1.1. Continuous implementation of On- going Member countries Action Plan being Dialogue Partners Japan TQM project discussed or other countries Country Coordinator: 9.1.2. Implementation of ASEAN On- going Member countries MALAYSIA Standardization and Conformance Programme

9.1.3. Operation of ASEAN- Japan Indonesia Website on Standards and Conformance

9.1.4. Other areas for possible 2003 onward ACCSQ cooperation with Japan

Cooperation at international ACCSQ with inputs standardization organizations from WG1 and Dialogue with Japan on conformity member countries assessment regimes Possible MRAs;

of 44 AREA ACTIVITIES REFERENCE/ ACTIVITIES IN EXPECTED OUTPUT TIME FRAME RESPONSIBLE STATUS OF DETAIL MEMBER/WG/PWG IMPLEMENTATION 9.2. Cooperation with 9.2.1 Possible action plan for 2003 onward ACCSQ/ member China cooperation with China on Standards countries and Conformance

Country Coordinator: 9.2.2. Implementation of action plan 2004 onward ACCSQ and China CAMBODIA with China

9.3. Cooperation with 9.3.1. Finalization of ACCSQ- CER 2003 ACCSQ and CER CER Action Plan

Country Coordinator: 9.3.2 Implementation of action plan 2004 onward ACCSQ and CER SINGAPORE

9.3.3 Implementation of AADCP 2004 onward ACCSQ and Project starts in August Australia 2004-2007

9.4 Cooperation with the 9.4.1. Implementation of the ASEAN 2003- 2006 Member countries On going implementation EC – EC project on Standards and and the EC for Cosmetic, Quality Pharmaceuticals, EE, Prepared Foodstuff, tourism, finance Country Coordinator: 9.4.2. Exploration of new areas for 2003 onward ACCSQ/ The ASEC INDONESIA cooperation with the EC

9.5. Cooperation with 9.5.1 Implementation of 3 year Action On-going ACCSQ and the US the US Plan

Country Coordinator: 9.5.2. Exploration of new areas for On-going ACCSQ (ASEC) VIET NAM cooperation with the US

9.6 Cooperation with 9.6.1 Exploration of areas of 2004 - ACCSQ and Korea Areas identified by Korea cooperation ACCSQ for consideration of Korea Country Coordinator: THAILAND 9.7. Cooperation with 9.6.1. Implementation of the project On- going The ASEC and Completed activities: PTB Germany “Support for the Metrology, WGs/ PWGs - Workshop on Standardization, Testing and Quality Harmonization for Country Coordinator: in ASEAN” Pre-packaged The ASEAN Secretariat Products - Workshop on Measurement Uncertainty

9.8. Cooperation with 9. 7.1 Possible cooperation with On-going UNIDO, CODEX/ FAO, UNIDO, CODEX/ FAO and WHO WHO Page 7 of 44 AREA ACTIVITIES REFERENCE/ ACTIVITIES IN EXPECTED OUTPUT TIME FRAME RESPONSIBLE STATUS OF DETAIL MEMBER/WG/PWG IMPLEMENTATION

Country Coordinator: The ASEAN Secretariat

10. Cooperation at 10.1. WTO TBT ASEAN common position at On-going ACCSQ/ Member relevant relevant organizations activities countries organizations Country Coordinator: THAILAND

10.2. APEC/ SCSC

Country Coordinator: BRUNEI DARUSSALAM

10.3. ASEM TFAP

Country Coordinator: THAILAND

10.4. ISO

Country Coordinator: MALAYSIA

10.5. IEC

Country Coordinator: SINGAPORE

11. New areas for 11.1. Standards in 11.1. Study and recommend On-going Taskforce on Regional Workshop on Cooperation Services possible cooperation on Standards in Standards in Standards in Services and Services in ASEAN Services TF Meeting held in July 2004. Recommendations and action plan endorsed by the 24th Meeting of the ACCSQ 11.2 Implementation of August 2004 ACCSQ recommendations -onwards

11.2. Quality and 11.2. Endorsement of areas for 2004 ACCSQ Productivity cooperation

( TO BE CONSIDERED)

of 44 ANNEX 1: ACTION PLAN OF THE JOINT SECTORAL COMMITTEE FOR THE ASEAN SECTORAL MRA ON ELECTRICAL AND ELECTRONIC EQUIPMENT (JSC EE MRA) (Adopted by 4rd JSC EE MRA)

GOAL AND ACTIVITIES EXPECTED OUTPUT COMPLETED RESPONSIBLE Status STRATEGY TIME FRAME AGENCY

Mutual Recognition Accelerate the implementation of All member countries notify their 2005 All member All member countries have notified Arrangement on the ASEAN EE MRA participation in acceptance of test countries their participation in either acceptance Electrical and report and product certification. of test report and/or product Electronic certification. Equipment Singapore and Thailand has submitted their proposed designated CABs during the 4th JSC EE MRA Meeting for consideration within 60 days.

Harmonization of Development of ASEAN Common ASEAN Harmonized Regulatory 2004-2005 JSC EE MRA The roadmap for harmonization of Regulatory Regimes Regulatory Regime Regime developed conformity assessment system in EE sector in endorsed by the 4th JSC EE MRA.. ASEAN Consensus on the hybrid approach Signing of the Agreement Agreement signed 2005 achieved.

The task force to prepare the draft Member countries to transpose National legislation that facilitate the 2006 – 2010 Member countries agreement comprising of Brunei the Agreement into national implementation of the ASEAN EE Darussalam, Indonesia, Malaysia legislation i harmonized regime (Lead Country), Philippines, Singapore, Thailand and Viet Nam and Development of Mark of Mark of compliance developed Starting 2006 JSC EE MRA the ASEAN Secretariat has been Compliance established.

Implementation of the EE A harmonized a regulatory regime 2010 – onwards Member countries Harmonized Regime for EE sector in ASEAN

Monitoring the implementation Implementation monitored 2010 - onwards JSC EE MRA

Technical Outreach programmes PTB is funding support for Training on Infrastructure Training on ISO/ IEC 17025; The training is conducted July 2004 Malaysia ISO/IEC 17025 in 2004. The 4th JSC EE MRA agreed that the Training on IEC 60335; and training to be conducted back to back with the 5th JSC EE MRA Training on IEC 60065 Meeting.

of 44 GOAL AND ACTIVITIES EXPECTED OUTPUT COMPLETED RESPONSIBLE Status STRATEGY TIME FRAME AGENCY

The proposed trainings on IEC 60335 and IEC 60065 will be considered in 2005.

Good Regulatory Exchange information on the Updated information is shared On-going All member Indonesia, Malaysia, Thailand and Viet Practice regulatory schemes of member Availability of member country’s countries Nam are currently preparing the countries booklet and information on booklet. Technical regulations mandatory requirements for of Thailand and the Philippines Electrical and Electronic Products will be available in their Websites soon. Comparison of standards used The report on comparison of the use March 2004 Indonesia Completed for regulated products with the of harmonized or international relevant 72 IEC Safety Standards standards in technical regulations Indonesia to prepare the summary of comparison to look into the extent of the harmonized standards in technical regulations To look into all remaining More regulated product to be 2004 onward Indonesia regulated products for harmonized to IEC standard harmonization to the relevant IEC standard where applicable.

of 44 ANNEX 2: ACTIVITIES TO BE UNDERTAKEN BY THE ASEAN COSMETIC COMMITTEE (ACC)

GOAL STRATEGY ACTIVITIES EXPECTED OUTPUT TIME RESPONSIBLE STATUS OF FRAME MEMBER IMPLEMENTATION ASEAN I. Preparation for the Harmonized Implementation of the Cosmetic Scheme: Regulatory Scheme is implemented 1.1 Notification of Member countries notify the Indication of The 1st ACC Member Countries 9 member countries (Brunei Member Countries to ASEAN Secretariat intention & Participation in the Meeting Darussalam, Cambodia, participate in the time frame to participate in ASEAN Harmonized Indonesia, Lao PDR, Malaysia, Schedule A/B Schedule A/B Cosmetic Regulatory Philippines, Singapore Scheme Thailand, Viet Nam) submit their notification

1.2 Establishment of Develop Guidelines for Guidelines for the The 1st ACC Philippines and ACA Completed Guidelines for the Implementation Implementation of the Meeting Implementation of the ASEAN Harmonized Scheme Cosmetic Regulatory Adopt the Guidelines Scheme The 1st ACC ACC Completed Meeting

1.3 Development of Develop Format for Notification Notification Format Before the Singapore The Draft Template was tabled Notification Format/ 3rd ACC at the 2nd ACC Meeting. Procedures for Meeting Singapore will revise the Participation in template according to Schedule B comments by Member Countries. The revised template will be circulated for consideration by Member Countries by mid June 04, and Singapore to finalize accordingly. Adoption of the Format 3rd ACC ACC Meeting II. Implementation and Monitoring of the Scheme:

2.1 Review of the Member Countries to review their Harmonization of Before 2008 Member Countries Working groups comprising of National Legislation in National Legislation technical requirements authorities and industries were accordance to the and legislation formed to prepare for the ASEAN Harmonized implementation of the AHCRS. Cosmetic Regulatory (Reported in 2nd ACC Scheme Technical Meeting) Documents

of 44 GOAL STRATEGY ACTIVITIES EXPECTED OUTPUT TIME RESPONSIBLE STATUS OF FRAME MEMBER IMPLEMENTATION 2.2 Implementation of Start Implementation of Mutual Acceptance of Starting of Member Countries Malaysia is now ready Schedule A Schedule A Product Registration October intend to participate in Philippines - 2005 Approval 2003 Schedule A

2.3 Monitor Conduct monitoring of the Monitoring report and Starting of ACC, Chair /Co-Chair No country entering into MRA Implementation of implementation of Schedule A recommendation to October and ASEC so far. Schedule A and determine readiness of move to Schedule B 2003 these member countries to move to Schedule B

2.4 Implementation of Start Implementation of January Member Countries Member Countries (except Schedule B – the Schedule B 2008 Myanmar and Vietnam) have ASEAN Cosmetic confirmed their readiness for Directive the implementation of the Schedule B by Jan 2008. Singapore may start earlier than the year 2008 Infrastructure III. Implementation of needs are program to address identified and infrastructure needs programs are developed to address need 3.1 ASEAN Cosmetic Acquisition of background Information from June 2003 Malaysia (Lead Completed GMP information member countries Country) & member countries

Identification of infrastructure Recommendation and 1st ACC Malaysia Completed needs and development of Roadmap Meeting roadmap based on the information collected

Development of Project Proposals for submission to dialogue Partners: - EU End of Malaysia, ASEC, Completed December ACA 2003

- Australia July 2004 Malaysia, ASEC, Submit proposal to seek ACA funding. 3.2 Post Marketing Acquisition of background Information from July 2003 Singapore (Lead Completed Surveillance and Safety Information member countries Country) & member Evaluation countries

Identification of infrastructure Survey Report and 1st ACC Singapore Completed needs based on the information Recommendation Meeting collected Page 12 of 44 GOAL STRATEGY ACTIVITIES EXPECTED OUTPUT TIME RESPONSIBLE STATUS OF FRAME MEMBER IMPLEMENTATION Feedback from member End of Singapore Completed countries February 2004 Development of Project Proposals for submission to Dialogue Partners: EC-ASEAN Program on End of Singapore, ASEC, Completed Standards and Conformity December ACA Assessment 2003

Training on Laboratory End of Singapore, ASEC No update Accreditation (Germany) December 2003

3.3 ASEAN Cosmetic Identification Terms of Reference 1st ACC Thailand (Lead Completed and adopted during Scientific Body of membership, structure and Meeting Country) the 1st ACC Meeting scope of the ACSB

Identification of issues to be Starting from ACC Review ASEAN Handbook addressed by the ACSB January Update EU Directive 2004

Nomination of members of the Before 3rd Member Countries & Nominations from Member ACSB by member countries ACC ACA Countries were received Meeting except Myanmar and Vietnam. To request nomination from Myanmar and Vietnam.

Operation of the ACSB 2nd ACC TOR for ACSB was adopted in Meeting 2nd ACC Meeting. 1st ACSB Meeting was held June 9 in Bangkok.

3.4 Propose ASEAN Senior Experts, June 04 Member Countries ASEAN Senior Experts have Implementatio Country Junior Expert, and Sub- been proposed and agreed in n of the EC- committee 2nd ACC Meeting. ASEAN Junior Experts and Sub- Program committees to be proposed ASAP.

3.4.1 ASEAN Good Provide assessment, training To understand, 2004 - 2005 Team Leader, On - going Manufacturing and workshop implement and interpret Officers, Experts, Practice uniformly, among Member Countries Member States, the guidelines on ASEAN Cosmetic GMP.

of 44 GOAL STRATEGY ACTIVITIES EXPECTED OUTPUT TIME RESPONSIBLE STATUS OF FRAME MEMBER IMPLEMENTATION

3.4.2 Post-Marketing Provide assessment, training To provide assistance 2004 - 2005 Team Leader, On - going Surveillance/ and workshop on Capacity Building for Officers, Experts, Product Safety Laboratory Expertise, Member Countries Evaluation Safety and Efficacy Evaluation, Management of Adverse Events and non-conforming products

3.4.3 Institutionalizing Provide training and review To set up system, 2004 - 2005 Team Leader, On - going ASEAN ASEAN Handbook procedures and Officers, Experts, Cosmetic management of ASEAN ACSB Members Scientific Body Cosmetic Scientific Body and to review the ingredients listing

IV. Awareness Starting Member The 1st Regional Seminar Program to 2004 Countries/ASEC/ACA conducted in Hanoi, Vietnam stakeholders on 17 December 2003 (Seminar, Workshop, Publication) Information posted at the ASEAN Secretariat Website

Dissemination of information on the AHCRS to stakeholders has been carried out in most countries. (Reported in 2nd ACC Meeting)

of 44 ANNEX 3: WORK PROGRAMME OF THE ACCSQ PRODUCT WORKING GROUP ON PHARMACEUTICALS Adopted at 8th PPWG

GOAL STRATEGY ACTIVITIES EXPECTED OUTPUT TIME COUNTRY STATUS OF FRAME RESPONSIBL IMPLEMENTATION E

Harmonizati 1. To compare 1.1 Formation of a study group. 1.1 Study group formed Sept 1999 Malay on of existing product sia ASEAN registration To conduct comparative studies through 1.2 Report on the comparative (Lead Report on Comparative Pharmaceuti requirements for surveys, questionnaires, analysis and studies defining similarities and countr Study on Product cal pharmaceuticals workshops*, identify and prioritise differences. y) Registration for Regulations of ASEAN harmonized key areas Philippines Pharmaceuticals of member countries ASEAN Member 1.3. Circulation of report finding to ASEAN 1.3 Report circulated to ASEAN Countries presented at member countries for comments member countries * (pending on the 2nd PWP-P Meeting on the availability 5 March 2000 1.4 Presentation for approval of proposal 1.4 Proposal for harmonized key 31 Dec 99 of funding from on harmonized key areas to the areas for common technical ASEAN product working group on requirement Secretariat) pharmaceuticals.

2. To develop Setting of Ad-Hoc Committees to study 2.1 Drafts of harmonized technical Jan 2000 – common on key areas of technical documents requirements/ guidelines of the June 2001 technical submitted for registration to be in line with identified areas requirements for ICH/WHO guidelines. pharmaceutical product Areas of concern expected to be obtained registration for from 1.2 may include: ASEAN

of 44 GOAL STRATEGY ACTIVITIES EXPECTED OUTPUT TIME COUNTRY STATUS OF FRAME RESPONSIBL IMPLEMENTATION E

Pharmaceutical (Quality) . Responsible countries to submit June 2000 Indonesia . Received preliminary preliminary documents to (Lead country) doc. from responsible Indonesia Thailand, countries. . GMP Requirement (Indonesia) Philippines, . Analytical Procedures Validation . Indonesia to compile preliminary Sept 2000 Malaysia, . Compiling the (Philippines) documents & send draft proposal Singapore, preliminary doc. and . Process Validation (Singapore) to members for comments Vietnam, preparing the Draft 1 . Stability Studies (Thailand) . (Draft 1) Brunei to send to members . Bioequivalence Studies & Darussalam for comments. Interchangeability (Malaysia) . Members feedback Nov 2000

. Indonesia to prepare final Nov 2000 Common Technical Requirements (CTR) on Pharmaceutics (Quality) based on feedback (Draft 2) . Proposed CTR already been made and . Proposed CTR on Pharmceutics 3rd P-PWG subject to reformatting (Quality) to be presented for meeting adoption (Mar.01)

2.1.2 Pharmacological and Toxicological . Questionnaire on defined areas March 2000 Philip Data (Safety - Pre-Clinical Study) distributed to members pines . S1 – Carcinogenicity (Lead . S2 – Genotoxicity . Members to submit completed June 2000 countr . S3 – Kinetics questionnaire to Philippines y) . S4 – Toxicity Lao PDR, . Draft 1 circulated to . S5 – Reprotox . Philippines to compile feedback & Aug. 2000 Thailand members for . S6 - Biotech safety send draft proposal to members comments. . S7 – Pharmacology for comments (Draft 1) . M - Multidisciplinary . Members feedback Oct. 2000 . Philippines to prepare final CTR on Safety based on feedback (Draft 2)

. Proposed CTR on Safety to be 3rd P-PWG . Proposed CTR already presented for adoption meeting been made and (Mar.01) subject to reformatting

of 44 GOAL STRATEGY ACTIVITIES EXPECTED OUTPUT TIME COUNTRY STATUS OF FRAME RESPONSIBL IMPLEMENTATION E Clinical Data . Thailand to circulate draft proposal July 2000 Thailand (Lead . Draft 1 circulated to . Table of Contents of Clinical Study and to members (Draft 1) country) members for Related Information Malaysia, comments. . Tabular Listing of all Clinical . Members feedback Sept. 2000 Philippines A. Studies Singapore, . Clinical Study Report . Thailand to prepare proposal on Feb. 2001 Cambodia, Lao . Executive Summary Report Clinical Trial Data based on PDR, Viet Nam . Report of Bioavailability (BA) & feedback (Draft 2) Bioequivalence (BE) Studies . Reports of Studies using Human . Proposed CTR on Clinical Trial 3rd P-PWG . Proposed CTR already Biomaterial pertinent to absportion or Data to be presented for adoption meeting been made and disposition (Mar.01) subject to reformatting . Reports of Human Pharmacokinetic (PK) Studies . Reports of Efficacy & Safety Studies . Reports of Human Pharmacodynamic (PD) Studies . Reports of Post-Marketing Experience . Published and Unpublished Papers

Administrative Data

. Certificate of Pharmaceutical Product . Malaysia to circulate draft June 2000 Malaysia (Lead . Draft 1 circulated to (CPP) proposal to members (Draft 1) country) members for . Letter of Authorisation (LOA) Philippines, comments. . Labelling . Members feedback August 2000 Thailand, Myanmar . Patient Information Leaflet (PIL) . Malaysia to prepare final CTR on . Summary of Product Characteristics Administrative Data based on (SPC) feedback . Draft/Proposed Label . (Draft 2) . Patent/Trademark Evidence . Proposed CTR already . Language . Proposed CTD on Administrative 3rd P-PWG been made and . Application Form Data to be presented for adoption meeting subject to reformatting (Mar.01)

of 44 GOAL STRATEGY ACTIVITIES EXPECTED OUTPUT TIME COUNTRY STATUS OF FRAME RESPONSIBL IMPLEMENTATION E

2.1.5 Glossary . Draft glossary circulated to March 2001 Malaysia ASEAN member countries

. Member comment 30 Oct 01 . Proposed CTR already . Proposed Glossary to be 3rd P-PWG been made and presented for adoption (Draft 2) meeting subject to revising (Mar.01)

2.2 Circulation of draft of complete . Draft circulated to ASEAN July 2001 Lead Country ASEAN Common Technical Member countries Requirements (ACTR), Glossary, and CTD-Admin. to ASEAN member countries for comments.

2.3 Presentation for approval of the . Adoption the ACTR, Glossary, and 4th P-PWG Lead Country . The Draft 3 has been final draft to product working CTD-Admin. (Draft 3) meeting adopted and subject to group on pharmaceuticals. (Sep.01) revising

2.4 Correction on Draft 3 ACTR, . Member comment 30 Oct 01 Member Glossary, and ACTD-Admin. countries

. Revise Draft 3, as comment 30 Nov 01 Lead countries (Draft 4)

2.5 Revision and Adoption of ACTR, . Adoption of Draft-4 5th Meeting Experts and . Draft-4 has been Glossary, ACTD-Admin. (Feb.02) Lead Countries adopted and subject to revising . Adopted Draft-4 is revised and Apr.02 Experts and circulate to Member for comment Lead Countries

. Member feedback Jun 02 Member . Final-draft has been country adopted for ACCSQ Endorsement . Correction and to be presented 6th Meeting Experts and for adoption(Final-draft) (Sep.02) Lead Countries

of 44 GOAL STRATEGY ACTIVITIES EXPECTED OUTPUT TIME COUNTRY STATUS OF FRAME RESPONSIBL IMPLEMENTATION E - Revise, Circulation, Feedback, PPWG Lead Country Correction of the Final-draft (as meeting needed) and to be presented for -7th Meeting adoption (Jul.03)

-8th Meeting (Jul 04)

-9th Meeting

2.6 Submission of harmonized ACTR, . Submission the adopted Final- 21st ACCSQ Chair / Co- . Final-draft has been Glossary, and ACTD-Admin. for draft for Endorsement meeting chair endorsed by ACCSQ Endorsement Mar.03 ASEAN Sec.

. Submission "Revised Final-draft" ACCSQ Chair / Co- for endorsement (as needed) meeting chair ASEAN Sec.

3. To develop 3.1 Drafting of ASEAN common technical . Draft of ASEAN common technical 4th P-PWG Thailan common dossier (ACTD) for pharmaceutical dossier for pharmaceutical product meeting d technical dossier product registration registration (Draft 1) (Sept 2001) (Lead for . ACTD's Organization (Thailand) country Pharmaceutical . ACTD-Administrative Data (Malaysia) ) Product . ACTD-Quality (Indonesia) Philippines Registration for . ACTD-Non clinical data (Philippines) Indonesia ASEAN (ACTD) . ACTD-Clinical Data (Thailand) Singapore with a view of arriving at MRAs 3.2 Consolidating of draft ACTD . Completion of the draft ACTD and 30 Nov.01 Responsible . Draft-1 of ACTD was Submit to Thailand Lead Country adopted and subject to . Consolidation of each CTD 24 Dec 01 Thailand completing (Draft-1)

3.3 Study and Draft necessary . Draft “Guideline” to ACTRs (Draft- 24 Dec.01 Experts . Draft-1(some) were “Guideline” to ACTRs 1) circulated to Members . Circulate to Member countries 30 Jan.02 Lead Countries

3.4 Circulation of Draft-1 ACTD and . Draft-1 ACTD circulated to ASEAN 10 Jan 02 Thailand Guideline to ASEAN member member countries countries for comments.

3.5 Compilation of feedback on Draft-1 . Feedback from ASEAN member 30 Jan 02 Member ACTD from the ASEAN member countries compiled countries countries. Thailand

of 44 GOAL STRATEGY ACTIVITIES EXPECTED OUTPUT TIME COUNTRY STATUS OF FRAME RESPONSIBL IMPLEMENTATION E 3.6 Finalising the Draft-1 ACTD for . Draft-1 finalised and submit to the 15 Feb 02 Product Registration Application. Chair for the 5th Meeting

3.7 Presentation of Draft-2 ACTD - Adoption of Draft-2 ACTD (Draft-2 5th Meeting Experts and ACTD) (Feb.02) Lead country

3.8 Revision and Adoption of ACTD - Revise, Circulation, Feed back, PPWG Lead Counties Correction of the Final-draft(as meeting needed) and to be presented for -7th Meeting adoption (Jul.03)

-8th Meeting Indonesia - Final Draft has been (Jul 04) adopted for ACCSQ endorsement -9th Meeting

3.9 Submission of harmonized ACTD to . Revise, Circulation, Feedback, 6th Meeting Experts, Lead - Final-draft has been ACCSQ for endorsement Correction and to be presented for (Sep.02) countries adopted for ACCSQ adoption (Final-draft) Member endorsement country

. Submission the adopted Final- 21st ACCSQ Chair / Co- - Final-draft has been draft for endorsement meeting chair endorsed by ACCSQ Mar.03 ASEAN Sec.

. Revise, Circulation, Feedback, PPWG Lead country Correction, and to be presented meeting for adoption (revised Final-draft) - 7th Meeting (as needed) (Jul.03) - 8th Meeting - 9th Meeting

. Submission the adopted Revised ACCSQ Chair / Co- Final-draft) for endorsement (as meeting chair needed) ASEAN Sec.

of 44 GOAL STRATEGY ACTIVITIES EXPECTED OUTPUT TIME COUNTRY STATUS OF FRAME RESPONSIBL IMPLEMENTATION E 4. To develop 4.1 Drafting of Guidelines(GL) to ACTR - Draft of Guidelines to ACTR 6th Meeting Lead Countries . Proposed Guidelines Guidelines to ACTR (Sep.02) has been adopted as a - GL on Analytical Validation(Thailand) Working-guidelines - GL on BA/BE Studies (Malaysia) -Revise draft to be presented for 7th Meeting Lead Countries - GL on Process Validation (Singapore) consideration (Jul.03) - GL on Stability Study (Indonesia) -Final-draft of Guidelines has been Lead Countries adopted . GL on Analytical Validation 7th Meeting Thailand

. GL on Process Validation 7th Meeting Singapore

. GL on Stability Study (by Oct 2003 Indonesia Circulation)

. GL on BA/BE Studies(by Oct 2003 Malaysia Circulation)

4.2 Revision and Adoption of the - Revise, Circulation, Feed back, PPWG Lead Countries Guidelines to ACTR Correction of the Final-draft(as Meeting needed) - 8th Meeting Indonesia . Final Draft for Stability (Jul 04) Guideline already adopted for ACCSQ endorsement

Malaysia . Final Draft for BA/BE already adopted for ACCSQ endorsement. The Task Force will be formed to work on ASEAN Comparator Product

Thailand . Member countries will review the pending and the new efficacy guidelines – and will provide feedback to Thailand and Thailand will form WG and report the outcome to the PPWG - 9th Meeting

4.3 Submission of Guidelines to ACTR for - Submission the adopted Final-draft 22nd ACCSQ Chair/Co-chair Endorsement for Endorsement (Jul.03) ASEAN Sec.

of 44 GOAL STRATEGY ACTIVITIES EXPECTED OUTPUT TIME COUNTRY STATUS OF FRAME RESPONSIBL IMPLEMENTATION E - Submission ‘Revised Final-draft’ for ACCSQ Chair/Co-chair endorsement (as needed) Meeting ASEAN Sec.

5. To implement the 5.1 Setting of Task Force to organize, . IWG formed 6th Meeting Singapore(Cha . PPWG has agreed on harmonized coordinate and monitor the (Sep.02) ir) IWG ACTR, Glossary, implementation of the ASEAN CTD Indonesia(Co- Guidelines, and Chaie) . ACCSQ noted the ACTD in the Malaysia, IWG’s formation/duty ASEAN members Phillippines (in 21st ACCSQ) Thailand, Vietnam

5.1.1 TOR Establishing . IWG to develop and circulate for Dec.02 IWG comment of the SOP and POA

5.1.2 Developing SOP and Plan of . Correction and Revision into the Feb.03 IWG Action(POA) for Implementation Final-draft of SOP and POA

5.2 Implementing the harmonized ACTR, . Adoption those harmonized Jan 03-Aug Member Glossary, Guidelines, and product into the national system 03 country ACTD(harmonized products) . Implementation of the harmonized Member National System along products country with ACTD

. Trial period Sep.03 - Member Only one system, ACTD, Dec 08 country to be implemented for both local and imported . Full Implementation 1 Jan 09 Member product country

5.3 Assessment on Implementation . Assessment on Implementation Mar-Jul 03 IWG situation and identify training needed of and Training needed 6 mth. Member the Members Interval country

. Report and Recommendation from PPWG IWG Assessment Meeting Member 7th meeting country (Jul.03)

- 8th Meeting Singapore Chair of IWG report the (Jul 04) (Chair of IWG) outcome of the implementation status on the 3 rd IWG Meeting - 9th Meeting

of 44 GOAL STRATEGY ACTIVITIES EXPECTED OUTPUT TIME COUNTRY STATUS OF FRAME RESPONSIBL IMPLEMENTATION E 5.4 Training to Strengthen DRA Capacity . Identify "Training needed" for PPWG IWG and filling the gaps among the Implementation of harmonized Meeting Member Member products to be presented for - 7th Meeting country consideration/adoption (Jul.03)

- 8th Meeting Singapore Focal point and will (Jul 04) (Chair IWG) & conduct for the training Indonesia (Co- need assessment. Chair IWG)

Member Nominate a national Countries training coordinator and submit to Singapore and Indonesia

- 9th Meeting

. Training provided 2003-2004 - IWG - ACTR&ACTD Lead country - Member country

Implementati Review all other possible Sectoral MRA . Understanding & awareness on 2003 Chair/Co-chair Information on possible on of the on Pharmaceuticals the other possible "Sectoral MRA" onwards ASEAN Sec. Sectoral MRAs for Looking into the Roadmap for & Seminar IWG Pharmaceuticals was Possible "Sectoral Integration presented to the 7th MRA of Meeting. Pharmaceuti cal Product . Possible “sectoral MRAs” 8 th PPWG ASEC & WHO Presenting 4 potential (Jul 04) areas for possible MRAs

Study the feasibility and develop an Sectoral MRA for Reccomend Assigned Issue to be discussed ASEAN mutual recognition arrangement Pharmaceutical/Medicinal Products in ation to Member further at the next PPWG (MRA) on Pharmaceutical Products in ASEAN SEOM by countries Meeting ASEAN December 2005 Implement the ASEAN Common 31 Dec 2008 Member Technical Dossier (ACTD) Countries

Harmonise the labelling standards for 31 Dec 2006 Malaysia Adopted in 2 nd PSC pharmaceuticals/ Medicines products Meeting and being implemented.

of 44 GOAL STRATEGY ACTIVITIES EXPECTED OUTPUT TIME COUNTRY STATUS OF FRAME RESPONSIBL IMPLEMENTATION E Explore the feasibility of implementing a on-going flexible twinning system, where member countries voluntarily pair with one or other member countries to co-operate in enhancing mutual regulatory capacity and resource development

Formalise a post-marketing alert system 31 Dec 2005 Singapore & for defective and unsafe pharmaceutical/ Malaysia medicine products

Cooperation 1. WHO-ASEAN 1.1 Establishment of ‘WHO-ASEAN . Development of ‘WHO-ASEAN Jul.01 Chair/Co-chair with Cooperation Cooperation’ Harmonized Project’ ASEAN Sec. International Organization 1.2 Implementation of the ‘WHO-ASEAN - Identification of ‘Support needed’ Jul.01 and Cooperation’ onwards. ACCSQ- Dialogue - Support provided 4th Meeting onwards

2. Cooperation with 2.1 Identify ‘Potential International . Potential ‘Partners’ identifies 7th Meeting Chair/Co-chair the Others Organization and ACCSQ-Dialogue onwards ASEAN Sec. Partner’ for PPWG cooperation IWG Member country

2.2 Cooperation with EC-ASEAN Cooperation Project 8th Meeting Chair/Co-Chair Adopted in 2nd PSC (Jul 04) ASEC Meeting and being implemented.

of 44 ANNEX 4: The revised Timeframe for the implementation of Work Programme of PF PWG (In response to the HLTF recommendation for acceleration of ASEAN MRA for prepared foodstuff)

No Objectives / Activities 2003 2004 2005 2006 2007 2008 Responsible . country 1. Transparency of Prepared Foodstuffs regulatory regime among member countries Ongoing process achieved 1.1 Exchange of information on the existing standards, regulations, procedures and mandatory Thailand requirements in Member countries related to Prepared Foodstuffs well operated - Develop proposal on the establishment of the ASEAN Consultative Network on PF Feb Thailand - Member countries to identify the national contact points for the network May Member countries 1.2 Compiled Information template of all ASEAN member countries disseminated - To develop information exchange template Mar Thailand - To circulate information exchange template to ASEAN Member countries for completion May Thailand - Member countries to submit the completed information Aug Member countries - To compile the completed information exchange template from ASEAN member Oct Thailand countries - To disseminate the compiled information exchange template through electronic Sep Thailand communication Ongoing process 1.3 English version of the technical regulation related to prepared foodstuff available - To translate the technical regulation related to prepared foodstuff by each ASEAN Jun Member countries Ongoing process member country into english - Publication of the technical regulation in the national website Oct Member countries 1.4 Profile of regulatory regime of ASEAN on prepared foodstuff developed - To review, analyze and define similarities and differences of the member countries, Sep Mar Thailand regulatory regime and develop the profile of ASEAN regulatory regime for prepared foodstuff - To publicize the profile through electronic communication Mar Thailand . To maintain and update the profile Mar  Indonesia DiscussionThailand Paper Ongoing process  The 3rd Meeting of the ACCSQ Prepared Foodstuff PWG 2. Specified area for MRA of Prepared foodstuff identified 9-10 2004, Bangkok, Thailand 2.1 Possible area for prepared foodstuff MRA listed  - To develop listing of possible area for prepared foodstuff of ASEAN member countries July Indonesia - To review and analyze the listed possible area for similarities and differences Sept Indonesia 2.2 Specified area for MRA agreed

of 44 No Objectives / Activities 2003 2004 2005 2006 2007 2008 Responsible . country - To identify the possible area for MRA and reach consensus (criteria for identification of Feb Indonesia possible MRAs for Prepared Foodstuff need to be provided) 2.3 Common technical document for possible MRA developed - To identify the related technical documents for prepared foodstuff MRA Jul Indonesia - To review and analyze the identified common technical documents for possible MRA Sep Indonesia - To reach consensus on common technical documents for possible MRA Nov Indonesia - To develop common technical document for possible MRA July - To submit the document to ACCSQ for endorsement Sept PF PWG - To endorse the document Sept ACCSQ - To develop MRA Sept PF PWG 3 Technical Infrastructure for prepared foodstuff enhanced 3.1 Coordinate and implement the EC- ASEAN Regional Economic Cooperation Programme in Member Countries the food sector 3.2. Cooperate with relevant international and regional organization to address issues related to Philippines/ member capacity building Ongoing process countries

4 Food Safety Standards for Prepared Foodstuff MRA strengthened 4.1 Food Safety Standards in Cooperation with International Agencies and other related ASEAN bodies developed - To identify specific Codex Technical Committees for coordination in ASEAN including ATFC hosting international meeting Ongoing process - To encourage ASEAN member countries to develop specific proposals for FAO/Codex Member countries Ongoing process

- To identify areas of existing and possible cooperation with the international organizations AEGFS Ongoing process 4.2 Confidence building for ASEAN and enhanced international trade - To monitor the implementation of food safety standards by ASEAN member countries, ATFC particularly Codex Ongoing process

4.3 Capacity building including Human Resources and Infrastructure Development . To compile information on capacity building needs/expertise available AEGFS Ongoing process

of 44 No Objectives / Activities 2003 2004 2005 2006 2007 2008 Responsible . country

- To develop suggested norms and Guidelines for infrastructure needs Mar AEGFS - ASEAN member countries to implement guidelines Nov Member countries - To develop Centers of Excellence June AEGFS Revised and Adopted at the 3rd PF PWG Meeting, 9-10 May 2004, Bangkok, Kuala Lumpur

NOTE : HLTF : High Level Task Force for ASEAN Integration PF PWG : Prepared Foodstuff Product Working Group ATFC : ASEAN Task Force on Codex AEGFS : ASEAN Experts roup on Food Safety

of 44 WORK PROGRAMME OF THE ACCSQ WORKING GROUP ON STANDARDS AND MRAs Adopted at 14th WG1 Meeting I. PART I - COMPLETED ACTIVITIES OF ACCSQ WORK PROGRAMME (1995 – 2003)

GOAL STRATEGY ACTIVITIES EXPECTED OUTPUT COMPLETED RESPONSIBLE TIME FRAME MEMBER/WG/PWG

Mutual Recognition 1. Drafting of the ASEAN 1.1 Development of a Roadmap for 1.1.1 Report on Roadmap for March 1998 Ad-hoc WG Arrangement Framework Agreement on MRA MRA MRAs

1.2 Preparation of an ASEAN 1.2.1 Framework Agreement December 98 WG1 Framework Agreement on finalised and signed MRAs

1.3 Contribution to the ASEAN 1.3.1 Articles submitted October 98 WG1 Standard and Quality bulletin on MRA issues

1.4 Workshop/seminars on MRAs 1.4.1 Workshop And Seminars 1998-2000 WG1/Member Countries organized for dissemination of information to regulators and industries Dissemination of information to regulators and industries

2. Implementation of the 2.1 Drafting the Interpretative 2.1.1 Adoption of the ASEAN Framework Notes: Interpretative Notes Agreement and facilitation of Sectoral MRAs - Preparing the 1st Draft - 1st Draft 1999 WG1

- Comments by Members - Comments received End of April 99 ASEC

- Consideration of the 1st Draft - Revised Draft 5th Meeting, May 99 - Comments on the Revised Draft - Comments May 99 ASEC

- Revise the Draft and send to - Third Draft 30 June 99 Members

- Report to ACCSQ 15 July 99 14th ACCSQ Meeting 2.2 Identification of priority sectors Priority sectors identified 1998-1999 WG1 for MRAs

of 44 GOAL STRATEGY ACTIVITIES EXPECTED OUTPUT COMPLETED RESPONSIBLE TIME FRAME MEMBER/WG/PWG

- Preparing trade and TBT Information Paper April 99 ASEC information

- Inputs from other WGs Sectors identified April 99 WG2,3

- Prioritization of sectors May 99 WG1

- Recommendations May 99 WG1

- Report to ACCSQ July 99 WG1

- Exploring the possibility of MRAs Recommendation March 2003 WG1 for Prepared Foodstuff (Product Working Group established) 2.3. Building blocks for the effective Paper to be presented to March 2002 WG1/ ASEC implementation of MRAs ACCSQ with recommendations

2.4. Road map of ASEAN G to G ACCSQ Process Map for ASEAN 2002 WG1/ ASEC MRAs to achieve market access Sectoral MRAs for industry 3. Possible MRAs with other - Development of concept paper Recommendation of sectors for 2002 - 2004 WG1/ ASEC region/ countries with CER possible MRAs with other regions Development of Concept Papers on Possible MRAs with China and Japan.

Submission of recommendations for consideration by ACCSQ

Standards 1. Harmonization of standards to 1.1 Completion of harmonization for Standard harmonized to August 2003 Former WG3 international standards 20 priority product groups international standards. covering 59 international standards.

1.2 Survey on Food Labelling - Food labelling standards or July 2003 Former WG3 Standards guidelines recommended for harmonization in ASEAN

- Transparency of food labelling standards and regulations in ASEAN

of 44 II. PART II – ON-GOING ACTIVITIES FROM 2003- 2006

GOAL STRATEGY ACTIVITIES EXPECTED OUTPUT TIME FRAME WG/ Dialogue Status of Partners Implementation Mutual 1. Implementation of Recognition the ASEAN Framework Arrangements Agreement

1.1. Facilitation of the 1.1 Monitoring the implementation of Successful implementation On- going WG1 ASEAN EE MRA: implementation of the following sectoral MRAs: of these sectoral MRAs - All member countries existing Sectoral MRAs submitted the official notification to - Electrical and Electronic participate in the Equipment ASEAN EE MRA - Cosmetics - JSC EE MRA to start - Pharmaceuticals listing of the - Prepared Foodstuff designated CABs

1.2 Advising the relevant bodies in Cosmetics: implementation of the sectoral - The Agreement MRAs. signed in Sept. 2003 - ASEAN Cosmetic Committee established - Malaysia and the Philippines will participate first in Schedule A - Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Singapore, Thailand and Vietnam will proceed directly to Schedule B (ASEAN Cosmetic Directive) on or before 1 January 2008.

Pharmaceuticals: - ACTDs and ACTRs are being implemented - MRA on Pharmaceuticals are being studies.

of 44 GOAL STRATEGY ACTIVITIES EXPECTED OUTPUT TIME FRAME WG/ Dialogue Status of Partners Implementation Prepared Foodstuff: - the ASEAN Consultative Network on Prepared Foodstuff was established - PF PWG are currently discussing the best approach (regulatory approach or product approach) to develop MRA for food sector

1.3. Establishment of an ASEAN 2003- 2004 Singapore 14th WG1 Meeting Guide on MRAs considered that a general Guide may not be useful due to differences of each sector 1.2. Identification of To be considered Additional Sectoral MRAs 2003 - 2006 WG1 Assessment conducted additional sectors for be concluded. for the 11 priority MRAs sectors

Standards 1. Harmonization of 1.1. Completion of harmonization of Standards harmonized to 2004 Member All 10 member countries additional product safety and EMC standards international standards Countries completed the groups harmonization work

2. Monitor the 2.1 Member countries to ensure On- going Member harmonized standards continuous harmonization practice countries and for 20 priority product for 20 priority product groups Singapore

2.2 Mechanism to monitor Singapore development in the international standards

2.3. Annual report to ACCSQ 3. Identification of news 3.1 Finalization of Survey on More national standards End of Nov. Malaysia Outcomes of the survey areas for harmonization National Standards in Technical harmonized with 2003 reported at the 14th of standards Regulations international standards Meeting

3.2 Development of criteria for Malaysia selecting standards for harmonization

3.3 Development of template for End of June Malaysia

of 44 GOAL STRATEGY ACTIVITIES EXPECTED OUTPUT TIME FRAME WG/ Dialogue Status of Partners Implementation identification and listing of relevant 2004 international standards for regulated products the 11 priority sectors

3.4 Identication and listing of Lead countries relevant international standards for End of July for 11 priority the regulated products in 11 priority 2004 sectors (Viet products Nam for agro- based and fisheries)

3.5 Submission to Malaysia for End of July Malaysia compilation and final assessment 2004

3.6 Recommendation on new areas End of Malaysia for harmonization of standards in September ASEAN including 11 priority sectors 2004 agreed by AEM

3.7 Agreement on new sectors for WG1 harmonization of standards

4. Confidence building 4.1. Survey on the use of No difference in standards End of Nov. Malaysia and Done among regulators in the harmonized standards for 20 used in technical 2003 JSC EE MRA outputs of international / priority product groups by regulations harmonized standards regulators.

4.2. Dissemination of information on WG1/ Member harmonized standards to countries regulators

4.3. Workshop/ traning on using of international/ harmonized standards for the development of technical regulations.

4.4 Promotion of participation of regulators in standards development process

5. Promotion of Good 5.1. Information sharing on the GRP Similar approaches to ongoing Brunei Regulatory Practice to issues regulatory management Darussalam Regulators (GRP) within ASEAN. This would improve the consistency Page 32 of 44 GOAL STRATEGY ACTIVITIES EXPECTED OUTPUT TIME FRAME WG/ Dialogue Status of Partners Implementation 5.2 Introduction of GRP concept to and transparency of 2003 onward regulators technical regulations, thereby reducing unnecessary obstacles to trade. 5.3. Regular dialogue for regulators PWGs to share experiences on regulatory reform programmes.

6. Cooperation in the 6.1. Implementation of mechanism Active participation and On- going Singapore/ framework of ISO, IEC, for discussion and coordinating of consensus-building in the Member APEC and ASEM position on technical and policy selected ISO/ TCs that Countries issues each member country has chosen to lead in.

6.2. Recommendations to ACCSQ Strengthening of ASEAN on proposals, activities or issues for position in relevant 2003 onward WG1 ASEAN Cooperation in these fora. international and regional fora. Exploration of 1. Consideration of 1.1 Recommendations for follow-up April 2004 Lead countries First draft assessment new areas for follow-up actions for 11 action for the following sectors: discussed at the 14th cooperation on priority product agreed WG1 Meeting MRAs and by AEM - Automotive - Indonesia Standards - Wood based - Indonesia - Healthcare Sector - Singapore - E ASEAN - Singapore - Rubber based product - Malaysia - Wood based - Philippines - Electronics - ASEC - Agro based and Fisheries - Thailand - Tourism - Thailand - Air travel - Malaysia - Textiles and apparels June 2004 WG1 Summary of 1.2 Submission of recommendation recommendations for ACCSQ endorsement finalized at the 14th WG1 Meeting

of 44 AN NEX 6:

ACTIVITIES TO BE UNDERTAKEN BY THE WORKING GROUP ON ACCREDITATION AND CONFORMITY ASSESSMENT (WG2)

Adopted at the 9th WG2 Meeting, 1-2 August 2004, Kuala Lumpur, Malaysia Time Party(ies) Status of Goal Strategy Activities Expected Output Frame Responsib Implementation le I. Accreditation

International/ 1. Examining the 1.1 Monitor development made 1.1.1 New information and June 2002 LC: Regional international and by the international and development circulated to onwards Thailand recognition of regional regional accreditation member countries and (PAC & member accreditation bodies discussed for possible IAF); countries’ bodies’ recognition collective actions Indonesia accreditation requirements and (APLAC & system assisting member ILAC) countries in meeting these 1.2 Review status of 1.2.1 Report on the levels/status July Member MoU signed: requirements accreditation systems in of member countries’ 1998 Countries APLAC – Brunei, Indonesia, member countries and accreditation systems onwards Malaysia, Philippines, Singapore, Thailand, develop a roadmap for Viet Nam Regional and International Recognition of 1.2.2 Roadmap developed December LC: Viet ILAC – Indonesia, Malaysia, Accreditation Schemes 2002 Nam Philippines, Singapore, Thailand, Vietnam

PAC – Indonesia, Malaysia (QMS), Philippines, Singapore, Thailand, Vietnam

IAF – Indonesia, Malaysia (QMS), Philippines (QMS), Singapore, Thailand

IATCA – Malaysia (Personnel Certification), Singapore (Auditor Registration), Thailand (Auditor Registration, Personnel Certification)

MLA/MRA signed: APLAC – Indonesia, Malaysia , Singapore (testing, calibration and inspection), Thailand, Vietnam

of 44 Time Party(ies) Status of Goal Strategy Activities Expected Output Frame Responsib Implementation le ILAC – Indonesia, Malaysia, Singapore, Thailand, Vietnam

PAC – Indonesia (QMS and EMS), Malaysia (QMS), Philippines (QMS), Singapore (QMS), Thailand (QMS and EMS)

IAF – Indonesia (QMS), Malaysia (QMS), Philippines (QMS), Singapore (QMS), Thailand (QMS)

IATCA – Singapore (Auditor Registration)

1.3 Develop programs/projects 1.3.1 Developed Programs/projects WG2/ Technical infrastructure for meeting identified recommended Member needs identified/programs needs: Countries developed and undertaken (ongoing) a. Training: (i) Accreditation Workshop Workshop conducted 1999 LC: Completed Philippines

(ii) Project Proposal on the Study Visit conducted November LC: Completed Study Visit to Developed 2000 Philippines Accreditation Bodies

(iii) Revised Project Proposal Competent accreditation 2003 LC: The project proposal has for Training on ISO/IEC Guides personnel onwards Singapore been approved by AADCP 61 and 65, including the respective IAF Guidance (iv) Project Proposal for training Competent accreditation and 2003 to LC: Thailand Malaysia (Component 1 of EMS Accreditation and certification personnel 2004 and 2 has been completed Certification Assessors in April 2004), Philippines (Component 2, completed in June 2004), Singapore and Viet Nam under negotiation

of 44 Time Party(ies) Status of Goal Strategy Activities Expected Output Frame Responsib Implementation le (v) Revised Project proposal for Competent accreditation 2003 to LC: The Workshop on workshop on Measurement personnel 2004 Singapore Measurement Uncertainty Uncertainty will be held on 3-5 Aug 2004 in Kuala Lumpur, Malaysia.

b. Attachment Programmes

(i) Developing specific Competence of accreditation 2003 LC: Pending until the source of programmes and revised bodies enhanced to meet onwards Thailand fund is available proposals for attachment regional international amongst ASEAN member requirements countries and more developed Accreditation Bodies (CER, USA, Japan and EU)

1.4 Consolidating ASEAN ‘s Common interest of ASEAN 2004 WG2 voice into regional and members are discussed for onwards international organization of possible agreement accreditation bodies

II. Conformity Assessment

Mutual 1. Strengthen 1.1 Survey of national testing 1.1.1 Directory of testing End of LC: Completed confidence in competence of capabilities for the priority capability 2001 Singapore conformity ASEAN Laboratories products assessment system 1.2 Revised Project Proposal 1.2.1 Technical MRAs between 2003 LC: Malaysia will continue to on ASEAN proficiency testing ASEAN organizations onwards Ma communicate with PTB for program (testing and lay the implementation of the calibration) sia project. an d Ind on esi a

of 44 Time Party(ies) Status of Goal Strategy Activities Expected Output Frame Responsib Implementation le 2. Strengthen 2.1 Conduct Seminar on 2.1.1 Seminar conducted 1997 WG 2 Third Seminar in KL in June competence of product certification 1997. Fourth Seminar in ASEAN product Viet Nam on 23rd June 1997 certification bodies 2.2 Establishment of Agency 2.2.1 Multilateral/Bilateral 1995 WG 2 Indonesia and Philippines Agreement Agreement Signed onwards concluded the MOU in 1997

2.3 Finalizing survey of 2.3.1 Status report of product End of WG 2 Completed conformity assessment certification 2001 procedures

3. Strengthen 3.1 Build up certification 3.1.1 Mutual Recognition of 2002 LC: The guidance document on competence of network within ASEAN system certification onwards Ma IAF Cross Frontier ASEAN systems countries lay Accreditation was accepted certification bodies sia by all members with a an transition period of six d months and implementation Vie from 1 May 2004 tna m

3.2 Conduct of training for 3.2.1 Increase competency level 2003 W Members to identify training certification personnel in carrying out system onwards G courses certification scheme 2

4. Cooperation with 4.1 Coordinate and provide 4.1.1 Facilitating sectoral MRAs 2004 Ch Proposal to be submitted to other WGs and PWGs support to other WGs and onwards air the 24th ACCSQ for their PWGs W consideration. G2 III. Assistance 1.1 Assistance in capacity 1.1.1 Accreditation and 2004 – - Project is under the IAI for to new ASEAN building on accreditation and conformity assessment 2008 standards and conformity members on conformity assessment system developed assessment accreditation and 1.2 Project proposal for 1.2.1 Awareness on laboratory 2003 W The project proposal has conformity seminar on ISO/IEC Guide 58 accreditation system onwards G2 been approved by AADCP assessment or ISO/IEC 17011 and ISO/IEC 17025 for CLM countries

of 44 Time Party(ies) Status of Goal Strategy Activities Expected Output Frame Responsib Implementation le IV. Monitoring 1.1 Conduct survey on situation of Certification of CBs in ASEAN: Bodies (CBs) in (i) Preparation of 19 June LC: Completed ASEAN survey questionnaire 2002 Ma lay sia (ii) Provide feedback 10 July to questionnaire 2002

(iii) Collate feedback 17 July 2002

(iv) Prepare report Status of foreign-based CBs in 20th ASEAN ACCSQ meeting

2.1 Identify problems and 2.1.1 Status report and 20th W recommend solutions recommendation to ACCSQ G2 ACCSQ meeting ch air

of 44 ANNEX 7:

ACTIVITIES TO BE UNDERTAKEN BY THE WORKING GROUP 3 ON TRACEABILITY MEASUREMENT

Adopted during the 4th WG3 Meeting, 1-2 August 2004, Kuala Lumpur, Malaysia COUNTRY IN CHARGE/ GOAL STRATEGY ACTIVITIES EXPECTED OUTPUT TIME POSSIBLE DIALOGUE STATUS OF IMPLEMENTATION FRAME PARTNER

1. Facilitation of 1.1 Harmonization of 1.1.1 Survey on Legal - Deep understanding of the 2001-2005 Viet Nam/ Project proposal was discussed removal of legal metrology Metrology starting point of each AADCP/PTB at the 2nd WGLM Meeting, Nov technical barriers legislation and Infrastructure of ASEAN member for the 2002 to trade administration all ASEAN harmonization so that the member needs, time frame and final countries, targets for each member will covering: be clarified

. Metrology Infrastructure . Local trade practices . Process of integration to the world

- Format for survey be Survey format January Viet Nam circulated to Member 2003 Countries

- Member Countries March 2003 respond to survey

- Workshop on Workshop June/July PTB 4th Meeting of the WG on Legal harmonization of conducted 2003 Metrology adopted the revised legislation and project proposal for endorsement administration on legal by the ACCSQ and further metrology. submission to PTB

- List of instruments for 2004-2005 harmonization in ASEAN - List of legal documents

- Requirements for identified 2004 instruments harmonized

of 44 COUNTRY IN CHARGE/ GOAL STRATEGY ACTIVITIES EXPECTED OUTPUT TIME POSSIBLE DIALOGUE STATUS OF IMPLEMENTATION FRAME PARTNER 1.1.2 Identification of 4th Meeting of the WGLM measuring instruments for identified Non Weighing harmonization in ASEAN Automatic Instrument and Liquid and timeframe for Fuel Dispenser as priority areas harmonization for harmonization.

1.1.3 Study Tour for senior officials on modernizing legal metrology.

1.2 Harmonization of 1.2.1 Workshop on - Discussion and 2003 Thailand/PTB - The 1st Workshop was held in requirements for pre- Harmonization of promotion of ASEAN Bangkok on 20-24 January packed products requirements for interest in requirements 2003. pre-packaged for pre-packaged - The 2nd Workshop was held products. products with other in Feb 2004 in Bangkok, national, regional and Thailand international organizations

- Draft of 2004 Thailand The ASEAN Common Recommendations on Requirements for Pre-Packaged the Requirements for Products was finalized and Pre-Packaged Products adopted during the 4th WG3 for ASEAN Meeting in August 2004 and submitted for ACCSQ endorsement

1.2.2 Follow-up to the - Cooperation in the area 2003 Workshop, of checking of pre- including packaged goods, through identification of cooperation in areas for possible technology, human harmonization in resources and expertise. ASEAN

1.2.3 Implementation 2008 with All Member Countries of the ASEAN flexibility for Common CLM Technical Countries Requirements for Pre Packaged Products

of 44 COUNTRY IN CHARGE/ GOAL STRATEGY ACTIVITIES EXPECTED OUTPUT TIME POSSIBLE DIALOGUE STATUS OF IMPLEMENTATION FRAME PARTNER 2. Improvement of 2.1. Training 2.1.1 Organize train-the- Harmonization of legal 2002 -2005 Malaysia/ legal metrology trainer courses / metrology systems through PTB/ systems in ASEAN workshops for Technical mutual understanding and AADCP/Japan Staff of legal metrology implementation of OIML organizations on the Recommendations in following: ASEAN and development of national capacity through (i) Verification of non- enhancement of technical Training course 2.1.1 (i) has automatic weighing competence of national been conducted on 8-13 April instruments in authority technicians and 2002 in Hanoi, Vietnam with accordance with trade measurement funding from NSC, Australia. OIML R76. inspectors. APLMF Training Course on Developing Legislation for the Implementation of OIML Recommendation R-87, 28-30 July 2004 in Kuala Lumpur, Malaysia. Assitance extended to CLM Countries

(ii) Verification of Training course 2.1.1 (ii) has Petroleum fuel been conducted on 4-9 August dispensers and LPG 2003 in Ha Noi, Viet nam dispensers in Funding support was extended to accordance with ACCSQ member economies who OIML R117. are members of APLMF

(iii) Verification of road Courses 2.1.1 (iii) – (iv) are weighbridges. dependent on consideration of funding proposals obtained from PTB / AADCP / ASEAN Secretariat. (iv) Pattern approval of non-automatic weighing instruments in accordance with OIML R76.

of 44 COUNTRY IN CHARGE/ GOAL STRATEGY ACTIVITIES EXPECTED OUTPUT TIME POSSIBLE DIALOGUE STATUS OF IMPLEMENTATION FRAME PARTNER 2.1.2 Identify and arrange Harmonization of legal 2002-2005 Malaysia/PTB/ Training course 2.1.2 (i) was for participation in regional metrology systems through AADCP/Japan conducted in Thailand in August training courses on the mutual understanding and 2002. Two training courses on following : implementation of OIML this matter will be held in Viet Recommendations in Nam and Thailand in August and (i) Calibration of rice ASEAN and development of November, respectively by the moisture meters. national capacity through year 2004 (ii) Measurement enhancement of technical uncertainty in legal competence of national Training 2.1.2(v) will be held metrology. authority technicians and In Viet Nam, 19-20 October 2004 (iii) Verification of CNG trade measurement flow meters/ inspectors. For the other courses identified dispensers the implementation dates are (iv) High capacity flow dependent on the consideration measurement. of funding proposals by PTB / (v) Seminar on Non- AADCP / ASEAN Secretariat and contact thermometer other sources and when such courses will be organized by APLMF.

2.2. Capacity building 2.2.1 Inventory of Access to Specialized Test 2002-2005 Indonesia/ The outcomes of the Survey capabilities of Testing & and Calibration Facilities for PTB/ discussed and recommendations Calibration Facilities obtaining OIML Certificate NZ/AADCP adopted during the 4th WG3 amongst the member for the members who do not Meting.Project Proposal on the countries have the facilities Importance of Accreditation to  Questionnaire Early 2003 be submitted for ACCSQ circulated to all endorsement and further member countries June 2003 submission to PTB  Member countries to respond to Indonesia

2.2.2 Training/workshop Consistency of grain 2003 Conducted in Thailand in August on certain method of grain moisture measurement 2002 moisture measurement

2.2.3 Workshop on the Accreditation of Legal 2003-2004 Importance of Metrology Authorities in the Accreditation in LM framework of MAA among the member countries

of 44 COUNTRY IN CHARGE/ GOAL STRATEGY ACTIVITIES EXPECTED OUTPUT TIME POSSIBLE DIALOGUE STATUS OF IMPLEMENTATION FRAME PARTNER 2.3. Assistance to 2.3.1 Assistance to CLM CLMV - needs assessment for Needs identified 2002 onward CLM/PTB/AADCP Survey conducted in Cambodia CLM in Legal metrology and Laos by PTB

- Implement Infrastructures addressed Agreement on future activities recommendations of reached needs assessment Workshop on Standards and Quality for CLMV was conducted on 7-10 Oct 2003

2.3.2 Assistance to CLMV AADCP/ASEAN-New NZ Aid finalized the Needs within the IAI Framework Zealand Cooperation Assessment for Legal Metrology Programme in CLMV Countries. CLMV Countries to submit specific needs and ongoing assistance from UNIDO to ASEAN Secretariat by 31 August 2004

3. Promotion of 3.1 Survey on the 3.1.1 Survey to cover all To determine the costs and 2002-2005 Singapore Project aborted during the 4th ASEAN interest in economic impact of ACCSQ WGLM members benefits of weighing and WGLM Meeting. Member legal metrology legal metrology – measuring instruments for countries are requested to submit weighing and trade use inputs for new project proposals measuring instruments for trade use

3.1.2 Review papers from To highlight key findings on 2002 onward APLMF/OIML member cost and benefits of legal countries on economic metrology impact of legal metrology

3.1.3 Propose to To determine the economic 2002-2003 commission a research impact (costs and benefits) project to determine the in dollar value of the economic impact on Weights and Measures weighing and measuring Programme in ASEAN instruments for trade use in ASEAN

of 44 COUNTRY IN CHARGE/ GOAL STRATEGY ACTIVITIES EXPECTED OUTPUT TIME POSSIBLE DIALOGUE STATUS OF IMPLEMENTATION FRAME PARTNER 3.2 Coordination of 3.2.1Identify potential A list of potential 2002 onward Chair/ASEC - National Legal ASEAN interest in national, regional and organizations endorsed by Metrology Agencies of legal metrology with international organizations the WGLM for future Japan, Australia, New other national, with regard to legal coordination Zealand and Germany regional and metrology for possible are observers and international cooperation partners for WGLM organizations - APLMF is the regional organization for cooperation 3.2.2 Highlight the Members are kept informed - activities of the relevant of Important activities of regional and international relevant regional and organizations, its international organizations implication to ASEAN and possible coordination is to achieved among WGLM Members

3.2.3 Cooperation with Some projects are to - relevant organizations submitted for funding support, if applicable