Key Documents
STANDARDS AND CONFORMANCE PLAN
1. End Term Review of the ASEAN Standards and Conformance Strategic Plan 2016-2025 (Public version)
2. ASEAN Standards and Conformance Strategic Plan 2016-2025
3. Roadmap and Action Plan to Promote Smart Manufacturing Development in ASEAN
4. Roadmap of ASEAN Standard Harmonization to Support SDGs Implementation 5. ACCSQ Sectoral Plan 2026-2030HARMONISATION OF REGULATORY REGIMES
POLICY & GUIDELINES
1. Working Group 1 – Standards and MRAs
- ASEAN Guideline on Standards, Technical Regulations and Conformity Assessment Procedures
- ASEAN Guidelines for Harmonisation of Standards
- Guidelines for Implementation of Harmonised Accreditation in ASEAN
- ASEAN Guidelines for Accreditation and Conformity Assessment
- ASEAN Guidelines for Sectoral Reference Laboratory Network
- ASEAN Guideline Verification of Flow Measuring Systems using Positive Displacements Flowmeter for Bulk Fuels
- ASEAN Guidelines for the Verification of Fuel Dispensers
- ASEAN Guidelines for Type Approval Control Systems
- Guidelines for the Verification of Non-automatic Weighing Instruments (NAWI)
- ASEAN Common Requirements of Pre-packaged Products
- ASEAN Guidelines on Increasing Public Awareness of Legal Metrology
- ASEAN Guidelines Medical Device Post-Market Information Exchange
- Final List of Risk Classification 44 Medical Device
- Guideline on Mandatory Adverse Event Reporting
- ASEAN Pharmaceutical Regulatory Framework (APRF)
- ASEAN Pharmaceutical Regulatory Policy
- Guidelines for Implementation of Harmonised Accreditation in ASEAN
- Glossary for ACTD & ACTR
- ASEAN Common Technical Documents (ACTD)
- ASEAN Common Technical Dossier (ACTD) Revision 1
- ASEAN Common Technical Requirements (ACTR)
- Labelling
- ASEAN Variation Guideline for Pharmaceutical Product Revision 1
- ASEAN Variation Guideline for Pharmaceutical Product Revision 2
- Question and Answer (Q&A)
- Joint Assessment Coordinating Group (JACG)
- Information for Applicants & Frequently Asked Questions
- List of Priority Product Types/Categories for ASEAN Joint Assessment Procedure
- Frequently Asked Questions (FAQ) on the ASEAN Joint Assessment (JA) Procedure
- ASEAN Joint Assessment Procedure for Pharmaceutical Products Information for applicants
- Joint Assessments Information Management System (JAIMS) demo link: https://youtu.be/IAwtK2iV-UQ
- Open Q & A Session between Industry Association Representatives with WHO on Joint Assessment Activities
- Joint Sectoral Committee on ASEAN MRA for Bioequivalence Study Report (JSC MRA BE)
- Technical Documents for Implementation ASEAN MRA for Bioequivalence Study Report
- Frequently Asked Questions (FAQs) on the ASEAN Mutual Recognition Arrangement (MRA) for Bioequivalence (BE) Study Reports of Generic Medicinal Products
- Procedures and Manual of Joint Sectoral Committee (JSC) and Annexes
- Operation Manual of the Panel of Experts (PoE) and Annexes
- Manual for Application of Bioequivalence (BE) Centre to be listed under ASEAN MRA BE and Annexes
- Technical Documents for Implementation ASEAN MRA for Bioequivalence Study Report
- ASEAN Guidelines on Nutrition Labelling
- Mechanism to Establish, Review and Update Food Safety Standards Harmonised in ASEAN
- ASEAN Guidelines on Specific Measures for Ceramic Articles Intended to Come into Contact with Foodstuffs
- ASEAN Principles and Guideline for the Establishment of Maximum Use Level for Food Additives;
- ASEAN General Guideline on Food Contact Materials;
- ASEAN Guidelines for Good Manufacturing Practice for Food Contact Materials.
- ASEAN General Standards for the Labelling Prepackaged Food
- ASEAN Principles and Criteria for The Establishment of Maximum Level for Contaminants and Toxins in Food and Feed
- ASEAN Food Safety Policy
- ASEAN Principles and Guidelines for National Food Control Systems
- ASEAN General Principles of Food Hygiene
- ASEAN Guidelines for the Design, Operation, Assessment and Accreditation of Food Import and Export Inspection and Certification Systems (CAC/GL 26 MOD)
- ASEAN Guidelines for Food Import Control Systems (CAC/GL 47 MOD)
- Guidelines for ASEAN Food Reference Laboratories (AFRL)
- ASEAN Principles for Food Import and Export Inspection and Certification (CAC/GL 20 MOD)
- ASEAN Food Testing Laboratory Committee (AFTLC)
- ASEAN Guidelines on GMP for Health Supplements (HS)
- ASEAN General Principles for Establishing Maximum Levels of Vitamins and Minerals in Health Supplements
- ASEAN Guidelines for Minimising the Risk of Transmission of Transmissible Spongiform Encephalopathies in Health Supplements
- ASEAN Guidelines on Claims and Claims Substantiation for Health Supplements
- ASEAN Guidelines on Limits of Contaminants for Health Supplements
- ASEAN Guiding Principles for the Use of Additives and Excipients in Health Supplements
- ASEAN Guiding Principles for Inclusion Into or Exclusion from the Negative List of Substances for Health Supplements
- ASEAN Guiding Principles on Safety Substantiation of Health Supplements
- ASEAN Guidelines on Stability and Shelf-Life of Health Supplements
- ASEAN Guidelines on Labeling Requirements for Health Supplements
- ASEAN Guidelines on GMP for Traditional Medicines (TM)
- ASEAN Guidelines for Minimising the Risk of Transmission of Transmissible Spongiform Encephalopathies in Traditional Medicines
- ASEAN Guidelines on Claims and Claims Substantiation for Traditional Medicines
- ASEAN Guidelines on Limits of Contaminants for Traditional Medicines
- ASEAN Guiding Principles for the Use of Additives and Excipients in Traditional Medicines
- ASEAN Guiding Principles for Inclusion Into or Exclusion from the Negative List of Substances for Traditional Medicines
- ASEAN Guiding Principles on Safety Substantiation of Traditional Medicines
- ASEAN Guidelines on Stability and Shelf-Life of Traditional Medicines
- ASEAN Guidelines on Labeling Requirements for Traditional Medicines
- Study on the Electronic Invoicing (E-Invoicing) Landscape in ASEAN Member States (AMS)
- Infographic DTSCWG
HARMONISATION OF STANDARDS & TECHNICAL REQUIREMENTS
1. Working Group 1 – Standards and MRAs
3. Working Group 3 – Legal Metrology
- Harmonisation Standards for 20 Priority Products, Safety and EMC
- Harmonisation of Standards in ASEAN
- FAQ Harmonisation of Standards in ASEAN
- Safety and EMC Standards for Harmonisation in ASEAN
- Directory of Standards and Technical Regulation/Requirements in the Construction Sector
| As of July 2020 : |
Consolidated Files |
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| As of June 2021 : |
Consolidated Files |
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| As of May 2022 : |
Consolidated Files |
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| As of May 2023 : |
Consolidated Files |
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| As of May 2024 : |
Consolidated Files |
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| As of May 2025 : |
Consolidated Files |
- ASEAN Guidelines for the Verification of Non-Automatic Weighing Instruments (NAWI)
- ASEAN Guidelines for Type Approval Control Systems
- Handbook on ASEAN Common Requirements for Pre-Packaged Products (ACRPP)
- Inter-Laboratory Comparison (ILC) Programs
- Harmonisation Status of Medical Device Standards
- ACCSQ MDPWG Common Submission Dossier Template
- List of Borderline Medical Device as of 13th AMDC Meeting
- List of Harmonised Medical Device Classification as of 13th AMDC Meeting
- ASEAN TMHS GMP Training
- ASEAN TMHS GMP Training – Chapter 1 Quality Management
- ASEAN TMHS GMP Training – Chapter 2 Personnel FD
- ASEAN TMHS GMP Training – Chapter 3 Premises and Equipment FD
- ASEAN TMHS GMP Training – Chapter 4 Sanitation and Hygiene FD
- Chapter 4 Annex 1 – SOP on Personal Hygiene
- Chapter 4 Annex 2 – Record Daily Inspection on Personal Hygiene
- Chapter 4 Annex 3 – Sample SOP General Health Examination
- Chapter 4 Annex 4 – Employee Illness Report Form
- Chapter 4 Annex 5 – Sample Pest Control Inspection Record
- Chapter 4 Annex 6 – Sample of Pest Control Monitoring Record
- Chapter 4 Annex 7 – Sample SOP on Pest Control
- Chapter 4 Annex 8 – SOP on Cleaning of Equipment and Accessories
- Chapter 4 Annex 9 – Cleaning Schedule Form
- Chapter 4 Annex 10 – Cleaning Record Form
- Chapter 4 Annex 11– Cleaning Inspection Form
- ASEAN TMHS GMP Training – Chapter 5 Documentation FD
- ASEAN TMHS GMP Training – Chapter 6 Production FD
- ASEAN TMHS GMP Training – Chapter 7 Quality Control FD
- ASEAN TMHS GMP Training – Chapter 8 Contract Manufacturing and Analysis
- ASEAN TMHS GMP Training – Chapter 9 Complaints and Recalls FD
- ASEAN TMHS GMP Training – Chapter 10 Self Inspection FD
- ASEAN TMHS GMP Training – Appendix 2 Verification FD
- ASEAN TMHS GMP Training – GMP Inspection
- Training Materials on ASEAN Guiding Principles on Safety Substantiation
- Matrix of Member States’ Technical Regulations or Mandatory Standards on Building and Construction Materials (BCM)
LABORATORIES SUPPORT
- APLAC Membership
- Inter Laboratory Comparison Report
- Directory of the Accredited Laboratories in the ASEAN Rubber Laboratory Network (ARLN)
Links
ACCSQ Dialogue Partners
ASEAN Food Safety Network
ACCSQ Medical Device Product Working Group website
National Standards Body
International and Regional Bodies
National Accreditation Bodies of ASEAN Member States
Publications
- Frequently-Asked Questions on the ASEAN Sectoral Mutual Recognition Arrangement for Electrical & Electronic Equipment (ASEAN EE MRA)
- General Information Booklet on the ASEAN Harmonised Cosmetic Regulatory Scheme
- ASEAN Consumer Information Handbook on Cosmetic Products
- Guideline for Development of Mutual Recognition Arrangements
