11 July 2007, Bandar Seri Begawan, Brunei Darussalam
By
Shirley V Ramesh Senior Officer
Standards and Conformance ASEAN Secretariat
Formed by the AEM at their 24th Meeting, Oct 1992, Manila
ACC
SQ
To facilitate the implementation of the
CEPT Agreement
To realise the ASEAN Free Trade Area (AFTA)
To assist in the
formulation of measures to realise the AEC To facilitate the integration
Agro-based
Air travel
Automotive
E-ASEAN
Logistics
Electronics
Wood
Tourism
Textiles
Rubber
Healthcare
Harmonisation of technical
barriers to trade Standards
•ASEAN Policy Guideline on Standards and Conformance
(ISO/IEC Guide 21 & Annex 3 of the WTO/TBT Agreement
•ASEAN Good Regulatory Practice Guide
Standards
ASEAN Common Technical Dossiers (ACTD)
ASEAN Common Technical Requirements (ACTR)
International Conference on Harmonisation Requirements (ICH) Pharmaceuticals
3 harmonised standards ISO
Rubber-based products
139 harmonised standards ISO and IEC
Electrical and electronics - Electrical appliances - Electrical safety - Electromagnetic compatibility
Outcome of harmonization Corresponding
Harmonisation of technical
barriers to trade Technical Regulations and MRAs
ASEAN Mutual Recognition Arrangement of Product Registration Approvals for Cosmetics signed on 2 September 2003
Cosmetics
Sectoral MRA on Good Manufacturing Practice Pharmaceuticals
ASEAN Electrical and Electronic Mutual Recognition Arrangement (ASEAN EE MRA) signed on 5 April 2002
Electrical and electronics
Mutual Recognition Arrangements
ASEAN Harmonised Cosmetic Regulatory Scheme signed on 2 September 2003. Cosmetics
ASEAN Harmonised Electrical and Electronic Equipment Regulatory Regime signed on 9 December 2005
Electrical and electronics
Harmonisation of technical barriers to trade
Standards
Technical Regulations
Conformity Assessment Procedures
ASEAN Good Regulatory Practice Guide ASEAN Policy Guideline on Standards and Conformance
-ISO/IEC Guide 21
-Annex 3 of the WTO/TBT Agreement
Standards
ASEAN Common Technical Dossiers (ACTD)
ASEAN Common Technical Requirements (ACTR) International
Conference on Harmonisation Requirements (ICH) Pharmaceuticals
3 harmonised standards ISO
Rubber-based products
…….harmonised standards ISO and IEC
Electrical and electronics - Electrical appliances - Electrical safety - Electromagnetic compatibility
Outcome of harmonization Corresponding
standards Sectors
ASEAN Mutual Recognition Arrangement of Product Registration Approvals for
Cosmetics signed on 2 September 2003
Cosmetics
Sectoral MRA on Good Manufacturing Practice Pharmaceuticals
ASEAN Electrical and Electronic Mutual Recognition Arrangement (ASEAN EE MRA) signed on 5 April 2002
Electrical and electronics
Mutual Recognition Arrangements
ASEAN Harmonised Cosmetic Regulatory Scheme signed on 2 September 2003.
Cosmetics
ASEAN Harmonised Electrical and Electronic Equipment Regulatory Regime signed on 9 December 2005
Electrical and electronics
Infrastructure and
Technical Requirements ASEAN Reference Laboratories (ARLs)
Six laboratories located in Malaysia, Singapore, Thailand and Viet Nam serving as ARLs for mycotoxins, pesticide residues, veterinary drugs, microbiology, heavy metals and genetically modified organisms.
ASEAN Common Food Control Requirements (ACFCR) - ASEAN Common Principles for Food Control Systems
- ASEAN Common Principles and Requirements for the Labelling of Prepackaged Food - ASEAN Common Principles and Requirements for Food Hygiene
ASEAN Common Technical Dossiers (ACTD)
ASEAN Common Technical Requirements (ACTR)
ASEAN Common Submission Dossier for Medical Devices Medical Devices
ASEAN Conformity Mark Post-market surveillance
system
A regional third- party mark of conformity to indicate that a product is in conformity with the particular ASEAN Harmonized Technical Regulations/ Requirements specified under the relevant ASEAN Agreements
ASEAN Agreement on the Application of ASEAN Conformity Mark to be signed in 2007
ASEAN Cosmetics Directives to be implemented by AMCs by 1 January 2008
A move from the traditional and preferred approach of pre-market approval to the new approach of post-market surveillance.
Capacity building
DONOR AGENCIES
PTB - Technical assistance in implementation of AHCRS and Legal Metrology
ITC - Capacity building on PMS and GMP for ASEAN Harmonised Cosmetic Regulatory Scheme (AHCRS)
World Bank - Technical assistance to CLMV in implementation of AHCRS
Australia - Strengthening Standards and Conformity Assessment for Cosmetics, EEE, Pharmaceutical, Prepared Foodstuff
Japan - Technical assistance in standards and conformance and TQM
USA - Healthcare Sector integration activities
NZ - Capacity Building in Legal Metrology for CLMV
EC- Strengthening Standards and Conformity Assessment for Cosmetics, EEE, Pharmaceutical, Prepared Foodstuff
25th Meeting of ACCSQ, 9-10 March 2005, Vientiane
…..designed to facilitate intra-ASEAN trade for the realisation of AFTA
…..products subject to mutual recognition in ASEAN MRAs are manufactured in ASEAN by an AMC
…..for products manufactured by a country outside ASEAN, the recognition of the test reports and
certification would be subjected to agreement by AMCs concerned and that particular country outside ASEAN …..agreed on basis of developments of ASEAN MRAs
A manufacturer incorporated and operating
within the boundary of ASEAN that carry out
manufacturing activities and are responsible
for the quality of the product concerned.
ASEAN Framework Agreement on
Mutual Recognition Arrangements
…..signed on 16 December 1998
…..general principles for developing sectoral MRAs
Three sectoral MRAS have been developed
Electrical and
…..ASEAN Electrical and Electronic Mutual Recognition Arrangement
…..signed on 5 April 2002, Bangkok
….. all AMCs have notified participation in recognition of test reports ….. seven AMCs (except Malaysia (2010), Philippines and Thailand) have notified participation in acceptance of certification
…..13 testing laboratories and one certification body listed under the ASEAN EE MRA
…..signed on 9 December 2005
….. leading to a single regulatory regime by 2010
ASEAN HARMONIZED ELECTRICAL AND ELECTRONIC
EQUIPMENT REGULATORY REGIME
….. eliminate restrictions to trade of EEE in ASEAN
…..facilitate the negotiations for MRAs on conformity assessment between ASEAN and
Taking full consideration of AMCs commitment to the
WTO/TBT Agreement………
…..which encourages Contracting Parties to enter into negotiations for the conclusion of agreement for the mutual recognition of results of each other's conformity assessment and mandates, among others, the
ASEAN HARMONISED COSMETIC
REGULATORY SCHEME
…..signed on 2 September 2003, Phnom Penh
…..a single regulatory scheme for cosmetics in ASEAN from 1 January 2008
…..no requirement for registration of products before placing in market; self-declaration of compliance
Schedule A
Schedule B
Mutual Recognition Arrangement of Product Registration Approval
ASEAN Cosmetic Directive
…..product registration processed and issued in one country is
recognised by the AMCs who have signed the MRA
…preparatory stage for AMCs to proceed to Schedule B
…for implementation by AMCs between now and 1 January 2008
Schedule B: ASEAN Cosmetics Directives
…..product notification scheme that does not require registration
…..the company shall file the product notification with the
regulatory agency in the country prior to placing the cosmetic
product in the market
ASEAN Common Technical Dossiers
- covering administrative data, quality, safety and efficacy
- marketing authorization application dossier that is common to all AMCs
ACTD
ASEAN Common Technical Requirements - covering quality, safety and efficacy
- set of written materials, intended to guide
applicant(s) to prepare application dossiers in a way that is consistent with the expectations of all ASEAN Drug Regulatory Authorities
- series of guidelines for the implementation of the ATCR are being finalized.
Labelling
-Harmonization of labeling requirements for pharmaceuticals has been completed
Labelling
Sectoral Mutual Recognition Arrangement on Good Manufacturing Practice (GMP) Inspection
- to facilitate the movement of pharmaceutical products in region
- to reduce the regulatory cost for industry in ASEAN
ASEAN Common Principles for
Food Control
Systems ASEAN
Common Principles and
Requirements for Food
Hygiene ASEAN
Common Principles and Requirements for
the Labelling of Prepackaged
Food
- Cosmetics
- Medical Devices and Equipments - Pharmaceuticals
