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
HARMONISATION OF REGULATORY REGIMES
POLICY & GUIDELINES
1. Working Group 1 – Standards and MRAs
- Policy Paper on the ASEAN Foresighting Framework (AFF)
- 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 Automatic Catchweighing Instruments – Version 2.0
- 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 Guideline on Establishing ASEAN Pharmaceutical Method (APM)
- 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 |
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| As of June 2026 : |
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
- Harmonized Borderline Medical Device – as of 16th AMDTC (Endorsed by 14th AMDC)
- Harmonized Risk Classification – as of 16th AMDTC (Endorsed by 14th AMDC)
- 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
ASEAN Food Safety Networks
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
Agreements and Declarations
AGREEMENTS
1. ASEAN Agreement on Medical Device Directive (2014)
- Interpretative Notes for AMDD
- Annex 1: Essential Principles of Safety and Performance of Medical Devices
- Annex 2: Risk Classification Rules for Medical Devices other than IVD Medical Devices
- Annex 3: Risk Classification Rules for IVD Medical Devices
- Annex 4: ASEAN Common Submission Dossier Template
- Annex 5: Post Marketing Alert System (PMAS) Requirements
- Annex 6: Components Elements of a Product Owner’s or Physical Manufacturers’ Declaration of Conformity (DOC)
- Annex 7: Labelling Requirements
- Annex 8: Clinical Investigation
- Member States Regulation
- Singapore Regulations on Medical Device
- Member States Regulation
- Appendix A: Terminology
- Appendix B: ASEAN Essential Requirements for Regulated EEE
- Appendix C: ASEAN Harmonized Conformity Assessment Procedure for EEE
- Appendix D: Technical Files
- List of Harmonised International Standards and Regulatory Requirements
- Risk Assessment Guidelines on EEE
- Consolidated Regulatory regime of EEE of the ASEAN Member States
- Updated Regulatory Regime of Cambodia, July 2012
- Updated Regulatory Regime of Indonesia, Feb 2023
- Updated Regulatory Regime of Malaysia, Jan 2026
- Updated Regulatory Regime of Myanmar, February 2016
- Updated Regulatory Regime of Philippines – approved IRR of DAO 3 on LVE
- Updated Regulatory Regime of Philippines , March 2016
- Updated Regulatory Regime of Singapore, August 2025
- Updated Regulatory Regime of Thailand, Sept 2025
- Updated Regulatory Regime of Viet Nam , May 2016
- Survey on Technical Infrastructure on Electrical and Electronic Products in ASEAN
- Criteria for being designated as Testing Laboratories or Certification Bodies for the implementation of the Sectoral MRA
- Listed Testing Laboratories and Certification Body
- Information Booklet on AHEEERR
- List of Additional Requirements and Critical Interpretation
- Contact Points
- ASEAN Mutual Recognition Arrangement of Product Registration Approvals for Cosmetics
- ASEAN Cosmetic Ingredient Listing
- ASEAN Handbook of Cosmetic Ingredients
- ASEAN Cosmetic Good Manufacturing Practices
- FAQ on the Interpretation on ASEAN GMP Guideline for Cosmetic
- ASEAN Cosmetic Good Manufacturing Practice (GMP) Training Modules (i) Contract Manufacturing (ii) Documentation (iii) Equipment (iv) Internal Quality Audit (v) Personnel (vi) Premises (vii) Product Complaint (viii) Production (ix) Quality Control (x) Quality Management (xi) Recall (xii) Sanitation and Hygiene (xiii) Storage (xiv) Inspection
- ASEAN Definition of Cosmetics and Illustrative List by Category of Cosmetic Products
- ASEAN Cosmetic Product Information File (PIF)
- ASEAN Cosmetic Notification
- Guidance on Product Notification to the Regulatory Authority
- FAQ on the Interpretation on Cosmetic Product Notification
- ASEAN Cosmetic Safety Assessment
- Guidelines for Safety Assessment of a Cosmetic Product
- ASEAN Botanical Safety Assessment Guideline
- A Guide Manual for Adverse Event Reporting
- ASEAN Guidelines on Limits of Contaminants for Cosmetics
- ASEAN Sunscreen Labelling Guideline
- General Information Booklet on ASEAN Harmonized Cosmetic Regulation Scheme
- ASEAN Consumer Information Handbook on Cosmetic Product
- ASEAN Accredited Cosmetic Laboratories
- ASEAN Cosmetic Harmonized Testing Method to Support the Post Marketing Surveillance (ASEAN Cosmetic Method/ACM)
- Q&A on Specific Provisions of the ASEAN Cosmetic Directive (ACD)
- Compulsory Documents/Template for the Implementation of ACD
- Notification
- Report for Adverse Cosmetic Event
- Reference Documents for the Implementation of ACD
- ASEAN Microbiological Test Limits
- Contact Points
- Joint Opinion Statements (JOS) for Talc
-
ASEAN Cosmetic Committee (ACC) Statement on Antimony in Cosmetics
MUTUAL RECOGNITION ARRANGEMENTS (MRA)
1. ASEAN Framework Agreement on Mutual Recognition Arrangements (1998)
ASEAN Framework Agreement on Mutual Recognition Arrangements (2017)
- Interpretative Notes of ASEAN Framework Agreement on Mutual Recognition Arrangements
- Guidelines for the Development of Mutual Recognition Arrangements
- Guidelines for the Development of Mutual Recognition Arrangements (2018)
- What is MRA and how it is expected to help industry in the region?
- ASEAN Framework Agreement on Mutual Recognition Arrangements(2025)
- FAQ on ASEAN Sectoral MRA for Electrical & Electronic Equipment (ASEAN EE MRA)
- Criteria for being designated as Testing Laboratories or Certification Bodies for the Implementation of the Sectoral MRA
- Listing of Testing Laboratories and Certification Bodies for the ASEAN EE MRA
- Protocol to Amend ASEAN Sectoral Mutual Recognition Arrangement for Good Manufacturing Practice (GMP) Inspection of Manufacturers of Medicinal Products (Protocol to Amend MRA for GMP)
- 15 FAQs on the ASEAN MRA for GMP
- Listed Inspection Service under ASEAN MRA for GMP
MEMORANDUM OF UNDERSTANDING (MOU)
1. Memorandum of Cooperation between the Department of Commerce of the United States of America and the ASEAN Secretariat (2001)
2. The Memorandum of Understanding on Standards and Quality (1996)
3. Memorandum of Understanding on Standstill and Rollback on Non-Tariff Barriers among ASEAN Countries (1987)
