11 July 2007, Bandar Seri Begawan, Brunei...

11 July 2007, Bandar Seri Begawan, Brunei Darussalam

ByShirley V Ramesh

Senior OfficerStandards and Conformance

ASEAN [email protected]

Formed by the AEM at their 24th Meeting, Oct 1992, Manila

ACCSQ

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 of 11 priority sectors

Agro-based Air travel

Automotive E-ASEAN

Logistics

Electronics

WoodTourism

TextilesRubber

Healthcare

Fisheries

Harmonisation of technicalbarriers 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 standardsISO Rubber-based products

139 harmonised standardsISO and IECElectrical and electronics- Electrical appliances- Electrical safety- Electromagnetic compatibility

Outcome of harmonizationCorresponding standards

Sectors

Harmonisation of technicalbarriers 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 PracticePharmaceuticals

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


Technical Regulations

Harmonisation of technicalbarriers to trade

Standards


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


International Conference on Harmonisation Requirements (ICH)

Pharmaceuticals

3 harmonised standardsISO Rubber-based products

…….harmonised standardsISO and IECElectrical and electronics- Electrical appliances- Electrical safety- Electromagnetic compatibility

Outcome of harmonizationCorresponding 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


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



Infrastructure andTechnical 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 Submission Dossier for Medical Devices

Medical Devices

Pharmaceuticals

Prepared Foodstuff

ASEAN Conformity Mark

Post-market surveillancesystem

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 2008A move from the traditional and preferred approach of pre-market approval to the new approach of post-market surveillance.

Post marketing alert system for defective or unsafe medical device

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 activitiesNZ - Capacity Building in Legal Metrology for CLMV

EC- Strengthening Standards and Conformity Assessment for Cosmetics, EEE, Pharmaceutical, Prepared Foodstuff

DIALOGUE PARTNERS

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

ACCSQ’S DECISIONS ON 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.

An “ASEAN Manufactured Product” is a product manufactured by the said ASEAN Manufacturer”.

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 electronics Cosmetics Telecommunications

…..an important means of eliminating technical barriers to trade

…..enhancing intra-ASEAN market access

…..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

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 other countries or group of countries/blocs

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 elimination of unnecessary obstacles to trade, including those relating to technical regulations

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

…..a move from pre-market approval to post-market surveillance

Schedule A

Schedule B

Mutual Recognition Arrangement of Product Registration Approval

ASEAN Cosmetic Directive

ASEAN HARMONISED COSMETIC REGULATORY SCHEME

…..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 A: Mutual Recognition of Product Registration Approval

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

…..AMCs are committed to implement Schedule B by January 2008

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.

ACTR

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

GMP

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

ASEAN Common Food Control Requirements

- Cosmetics- Medical Devices and Equipments- Pharmaceuticals- Traditional Medicine and Health Supplements

11 July 2007, Bandar Seri Begawan, Brunei...

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