Overview
Trade of products among ASEAN members has been facilitated more than before and products costs are lesser, with the elimination of tariffs. However, there are still non-tariff issues that are delaying products to reach the market. These non-tariff issues include different product specifications, regulations on safety and quality, and the existence of requirements including pre-market approval requirements.
The mandate of eliminating those non-tariff barriers, also known as technical barriers to trade (TBT) is given to the ASEAN Consultative Committee for Standards and Quality (ACCSQ). The ACCSQ was established in to support the realisation of the ASEAN Free Trade Area (AFTA).
The elimination of technical barriers to trade is consistent with international principles such as: (i) transparency/exchange of information, (ii) harmonisation of standards, (iii) mutual recognition arrangements (MRA), (iv) harmonisation of regulatory regimes, and (v) technical cooperation. The initiatives and measures on reducing TBT constituted the realisation of AFTA in 2010, the establishment of the ASEAN Economic Community in December 2015, and towards further integration in line with the ASEAN Vision 2025.
Priority Areas of Cooperation
Harmonisation of standards in ASEAN is governed by the ASEAN Guidelines on Standards, Technical Regulations and Conformity Assessment Procedures (AG-STRACAP), and Guideline on Harmonisation of Standards. To further achieve free movement of goods and accept conformity assessment results in ASEAN, the ACCSQ adopted the mutual recognition arrangement (MRA) on conformity assessment results thereby removing the duplication of conformity assessment activities (such as testing, inspection or product certification) and facilitate the approval procedures for regulated goods, without compromising the quality of the product and the safety of the consumers. The development of sectoral MRAs is guided by the following ASEAN documents:
ASEAN Framework Agreement on Mutual Recognition Arrangements;
ASEAN Guidelines for the development of Mutual Recognition Arrangements;
ASEAN Guideline on Conformity Assessment;
ASEAN Guideline for Sectoral Laboratory Network.
The ACCSQ also looks into legal metrology where harmonisation of verification procedures of legal metrology instruments that are used in trade (weighing scales, flow meters, volumetric instruments, among others) are accurate and ensure value for money for the consumers.
The scope of eliminating TBT was further expanded and focused in line with the goal of ASEAN Priority Integration Sectors (PIS). These sectors are:
Agro-Based Products (Prepared Foodstuff – HS Codes 16 to 22);
Automotive;
Healthcare Products,
Cosmetics
Medical Devices
Pharmaceuticals
Traditional Medicines
Health Supplements;
Rubber-Based products;
Electrical and Electronic Equipment;
Building and Construction Materials;
Wood-Based Products, and;
Digital Trade Standards and Conformance.
Harmonisation of standards and technical requirements:
The harmonisation of standards and technical requirements in ASEAN has embarked on the following:
Harmonisation of safety and specification requirements covering electrical and electronic equipment, rubber gloves and condoms and rubber-based products with the relevant international standards such as International Organisation for Standardisation (ISO) and International Electrotechnical Commission (IEC) standards.
Harmonisation of standards/technical requirements for automotive products based on United Nations Economic Commission for Europe (UN) Regulations under the 1958 Agreement.
Harmonisation of standards on prepared foodstuff products using Codex Alimentarius standards, with focus on food safety aspects, namely: food additives, food contaminants and food contact materials. Guidelines on Food Control requirements are also being harmonised based on Codex Guidelines.
Harmonisation of technical requirements and drug registration dossier through the implementation of ASEAN Common Technical Requirements (ACTR) and ASEAN Common Technical Dossier (ACTD).
Harmonisation of standards for medical devices based on ISO standards as well as harmonisation of registration dossier through the adoption and use of ASEAN Common Submission Dossier Template.
Harmonisation of technical requirements for safety, quality and efficacy and product placement requirements of traditional medicines and health supplements (TMHS), including Good Manufacturing Practices Guidelines that also made reference to the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP Guidelines.
Common procedures on legal metrology such as the ASEAN Common Requirements on Pre-packaged Products and Common Verification Procedures for Non-automatic Weighing Instruments in line with International Organisation of Legal Metrology (OIML) Recommendations. Inter-laboratory comparison (ILC) programs have also been in place where comparison on mass and volume measurement standards had been conducted.
Mutual Recognition Arrangements:
The general guideline for the development of ASEAN Sectoral Mutual Recognition Arrangements (MRAs) is provided for in the ASEAN Framework Agreement on Mutual Recognition Arrangements where the following MRAs are developed, and with anticipation of other MRAs that are forthcoming.
ASEAN Sectoral MRA for Electrical and Electronic Equipment.
ASEAN Sectoral MRA for Good Manufacturing Practice (GMP) Inspection of Manufacturers of Medicinal Products.
ASEAN MRA on Bio-Equivalence Study Report of Generic Medicinal Products.
ASEAN Sectoral MRA for Inspection and Certification System on Food Hygiene for Prepared Foodstuff Product
Harmonisation of Regulatory Regimes:
Going beyond harmonisation of standards and technical requirements and MRAs, the ASEAN has also embarked on harmonising its regulatory regimes to establish a coherent and unified regulatory systems in the region.
The development of regulations of the AMS is guided by the ASEAN Good Regulatory Practice (GRP) Guide and the ASEAN General Principles on Harmonisation of Regulatory Regimes.
Three product sectors have undertaken this initiative:
Cosmetics, through the Agreement on ASEAN Harmonised Cosmetic Regulatory Scheme, signed in 2003.
Electrical and Electronic Equipment under the Agreement on the ASEAN Harmonised Electrical and Electronic Equipment Regulatory Regime, signed in 2005.
Medical Devices with the Agreement on ASEAN Medical Device Directive, signed in 2014.
ASEAN Standards and Conformance Startegic Plan 2016-2025
In line with the ASEAN Vision 2025, a ten-year strategic plan on standards, technical regulations and conformity assessment procedure, including legal metrology, was developed in 2016 and has been the guiding chart of ASEAN in continuously eliminating technical barriers to trade.
Major Committees and Sectoral Bodies
The ACCSQ is structured to support the integration of these sectors while reporting its progress to higher ASEAN bodies, as shown in the structure below. The ACCSQ also serves as a consultative platform for relevant stakeholders to discuss issues related to standards, technical regulation, conformity assessments and legal metrology.
The ACCSQ comprise of the heads of national standards bodies of the ASEAN Member States that meets at least once a year. The Contact Points of the members of the ACCSQ and the Schedule of Meetings of the ACCSQ and its working groups (WG) and product working groups (PWG) are available in the link provided.
Cooperation with Partners/Industry
The cooperation on standards and conformance go beyond ASEAN. The same principle on TBT elimination to facilitate trade is extended to the ASEAN partners under the specific chapter of the existing ASEAN Free Trade Agreements.
The following are the existing committee under the existing FTA chapter on TBT:
- ASEAN, Australia and New Zealand Free Trade Area (AANZFTA), Sub-Committee on Standards, Technical Regulations and Conformity Assessment Procedures.
- ASEAN China Free Trade Area (ACFTA), Sub-Committee on Standards, Technical Regulations and Conformity Assessment Procedures.
ASEAN-Japan Comprehensive Economic Partnership Agreement (AJCEP), Sub-Committee on Standards, Technical Regulations and Conformity Assessment Procedures.
ASEAN-Korea Free Trade Agreement (AKFTA), Working Group on Technical Barriers to Trade (TBT) and Sanitary and Phyto-sanitary measures (SPS).
ASEAN-Hong Kong Free Trade Area (AHKFTA)– Chapter on Standards, Technical Regulations and Conformity Assessment Procedures.
Regional Comprehensive Economic Partnership Agreement (RCEP), Chapter on Standards, Technical Regulations and Conformity Assessment Procedures.
Cooperation or engagement with the industry association associated with ASEAN is undertaken through the relevant product working groups. The guide on engagement with the industry is guided by the ASEAN Rules and Procedures on Private Sector Engagement.
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
1. Working Group 1 – Standards and MRAs
- ASEAN Guideline on Standards, Technical Regulations and Conformity Assessment Procedures
- ASEAN Guidelines for Harmonisation of Standards
2. Working Group 2 – Conformity Assessment
- Guidelines for Implementation of Harmonised Accreditation in ASEAN
- ASEAN Guidelines for Accreditation and Conformity Assessment
- ASEAN Guidelines for Sectoral Reference Laboratory Network
3. Working Group 3 – Legal Metrology
- 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
4. ASEAN Cosmetic Commitee (ACC)
5. Automotive Product Working Group (APWG)
6. Joint Sectoral Committee on Electrical and Electronic Equipment (JSC EEE)
7. ASEAN Medical Device Committee (AMDC)
- ASEAN Guidelines Medical Device Post-Market Information Exchange
- Final List of Risk Classification 44 Medical Device
- Guideline on Mandatory Adverse Event Reporting
8. Pharmaceutical Product Working Group (PPWG)
- 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
9. Prepared Foodstuff Product Working Group (PFPWG)
- 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)
10. Rubber Based Product Working Group (RBPWG)
11. Traditional Medicines and Health Supplement Product Working Group (TMHSPWG)
ASEAN Guidelines for Health Supplements (HS)
- 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 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
12. ASEAN Consultative Committee for Standards and Quality (ACCSQ)
13. Digital Trade Standards and Conformance Working Group (DTSCWG)
- Study on the Electronic Invoicing (E-Invoicing) Landscape in ASEAN Member States (AMS)
- Infographic DTSCWG
14. Building and Construction Working Group (BCWG)
1. Working Group 1 – Standards and MRAs
- 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
2. Working Group 2 – Conformity Assessment
Compilation of Accreditation and Conformity Assessment System in ASEAN
| As of July 2020 : | Consolidated Files | ||
| As of June 2021 : | Consolidated Files | ||
| As of May 2022 : | Consolidated Files | ||
| As of May 2023 : | Consolidated Files | ||
| As of May 2024 : | Consolidated Files | ||
| As of May 2025 : | Consolidated Files |
3. Working Group 3 – Legal Metrology
- 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
4. ASEAN Cosmetic Committee (ACC)
5. Automotive Product Working Group (APWG)
6. Joint Sectoral Committee on Electrical and Electronic Equipment (JSC EEE)
7. ASEAN Medical Device Committee (AMDC)
- 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
8. Pharmaceutical Product Working Group (PPWG)
9. Prepared Foodstuff Working Group (PPWG)
10. Rubber Based Product Working Group (RBPWG)
11. Traditional Medicines and Health Supplement Product Working Group (TMHSPWG)
- 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
12. Building and Construction Working Group (BCWG)
- Matrix of Member States’ Technical Regulations or Mandatory Standards on Building and Construction Materials (BCM)
- APLAC Membership
- Inter Laboratory Comparison Report
- Directory of the Accredited Laboratories in the ASEAN Rubber Laboratory Network (ARLN)
- 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
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
2. Agreement on the ASEAN Harmonized Electrical and Electronic Equipment (EEE) Regulatory Regime (2005)
- 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, Sep 2023
- 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, Oct 2023
- Updated Regulatory Regime of Viet Nam , May 2016
- Survey on Technical Infrastructure on Electrical and Electronic Products in ASEAN
- Information Booklet on AHEEERR
- List of Additional Requirements and Critical Interpretation
- Contact Points
3. Agreement on the ASEAN Harmonised Cosmetic Regulatory Scheme (2003)
- 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
4. ASEAN Food Safety Regulatory Framework (2016)
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?
2. ASEAN Sectoral Mutual Recognition Arrangement for Electrical and Electronic Equipment (2002)
- 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