An 04 ASEAN Secretariat presentation on SCA
11 July 2007, Bandar Seri Begawan, Brunei Darussalam
By
Shirley V Ramesh
Senior Officer
Standards and Conformance
ASEAN Secretariat
[email protected]
Q
S
C
AC
Formed by the AEM at their
24th Meeting, Oct 1992, Manila
To facilitate the integration
of 11 priority sectors
To facilitate the
implementation of the
CEPT Agreement
To assist in the
formulation of measures
to realise the AEC
To realise the ASEAN
Free Trade Area (AFTA)
Agro-based
Air travel
Automotive
E-ASEAN
Fisheries
Electronics
Healthcare
Logistics
Textiles
Rubber
Tourism
Wood
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
Sectors
Electrical and electronics
- Electrical appliances
- Electrical safety
- Electromagnetic
compatibility
Corresponding
standards
Outcome of harmonization
ISO and IEC
139 harmonised standards
Rubber-based products
ISO
3 harmonised standards
Pharmaceuticals
International
Conference on
Harmonisation
Requirements (ICH)
ASEAN Common Technical
Dossiers (ACTD)
ASEAN Common Technical
Requirements (ACTR)
Harmonisation of technical
barriers to trade
Technical Regulations and MRAs
Technical Regulations
Electrical and
electronics
ASEAN Harmonised Electrical and Electronic
Equipment Regulatory Regime signed on 9
December 2005
Cosmetics
ASEAN Harmonised Cosmetic Regulatory
Scheme signed on 2 September 2003.
Mutual Recognition Arrangements
Electrical and
electronics
ASEAN Electrical and Electronic Mutual
Recognition Arrangement (ASEAN EE MRA)
signed on 5 April 2002
Cosmetics
ASEAN Mutual Recognition Arrangement of
Product Registration Approvals for Cosmetics
signed on 2 September 2003
Pharmaceuticals
Sectoral MRA on Good Manufacturing Practice
Standards
Harmonisation of technical
barriers to trade
Technical Regulations
Conformity Assessment Procedures
ASEAN Policy Guideline on Standards and
Conformance
-ISO/IEC Guide 21
-Annex 3 of the WTO/TBT Agreement
ASEAN Good Regulatory Practice Guide
Technical Regulations
Electrical and
electronics
ASEAN Harmonised Electrical and
Electronic Equipment Regulatory
Regime signed on 9 December
2005
Cosmetics
ASEAN Harmonised Cosmetic
Regulatory Scheme signed on 2
September 2003.
Mutual Recognition Arrangements
Standards
Sectors
Electrical and electronics
- Electrical appliances
- Electrical safety
- Electromagnetic
compatibility
Corresponding
standards
ISO and IEC
Outcome of harmonization
Electrical and
electronics
ASEAN Electrical and Electronic
Mutual Recognition Arrangement
(ASEAN EE MRA) signed on 5 April
2002
Cosmetics
ASEAN Mutual Recognition
Arrangement of Product
Registration Approvals for
Cosmetics signed on 2 September
2003
Pharmaceuticals
Sectoral MRA on Good
Manufacturing Practice
…….harmonised standards
Rubber-based products
ISO
3 harmonised standards
Pharmaceuticals
International
Conference on
Harmonisation
Requirements (ICH)
ASEAN Common Technical
Dossiers (ACTD)
ASEAN Common Technical
Requirements (ACTR)
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.
Prepared Foodstuff
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
Pharmaceuticals
ASEAN Common Technical Dossiers (ACTD)
ASEAN Common Technical Requirements (ACTR)
Medical Devices
ASEAN Common Submission Dossier for Medical Devices
Post-market surveillance
system
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.
Post marketing alert system for defective or unsafe medical device
ASEAN Conformity Mark
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
Capacity building
DIALOGUE PARTNERS
Australia - Strengthening Standards and Conformity Assessment for Cosmetics, EEE,
Pharmaceutical, Prepared Foodstuff
EC- Strengthening Standards and Conformity Assessment for Cosmetics, EEE, Pharmaceutical,
Prepared Foodstuff
Japan - Technical assistance in standards and conformance and TQM
NZ - Capacity Building in Legal Metrology for CLMV
USA - Healthcare Sector integration activities
DONOR AGENCIES
ITC - Capacity building on PMS and GMP for ASEAN Harmonised Cosmetic Regulatory Scheme
(AHCRS)
PTB - Technical assistance in implementation of AHCRS and Legal Metrology
World Bank - Technical assistance to CLMV in implementation of AHCRS
ACCSQ’S DECISIONS ON MRAs
25th Meeting of ACCSQ, 9-10 March 2005, Vientiane
…..agreed on basis of developments of ASEAN MRAs
…..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
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
…..an important means of eliminating technical barriers to trade
…..enhancing intra-ASEAN market access
Three sectoral MRAS have been developed
Electrical and
electronics
Cosmetics
Telecommunications
ASEAN EE MRA
…..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 HARMONIZED ELECTRICAL AND ELECTRONIC
EQUIPMENT REGULATORY REGIME
…..signed on
9 December 2005
….. eliminate restrictions
to trade of EEE in ASEAN
….. leading to a single
regulatory regime by 2010
…..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
ASEAN HARMONISED COSMETIC
REGULATORY SCHEME
Schedule A
Mutual Recognition Arrangement of Product
Registration Approval
Schedule B
ASEAN Cosmetic Directive
Schedule A: Mutual Recognition of Product Registration Approval
…..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
…..AMCs are committed to implement Schedule B by January 2008
ACTD
ASEAN Common Technical Dossiers
- covering administrative data, quality, safety and
efficacy
- marketing authorization application dossier that is
common to all AMCs
ACTR
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
Labelling
-Harmonization of labeling requirements for
pharmaceuticals has been completed
GMP
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 Food Control Requirements
ASEAN
Common
Principles and
Requirements for
the Labelling
of Prepackaged
Food
ASEAN
Common
Principles for
Food Control
Systems
ASEAN
Common
Principles and
Requirements
for Food
Hygiene
- Cosmetics
- Medical Devices and Equipments
- Pharmaceuticals
- Traditional Medicine and Health Supplements
By
Shirley V Ramesh
Senior Officer
Standards and Conformance
ASEAN Secretariat
[email protected]
Q
S
C
AC
Formed by the AEM at their
24th Meeting, Oct 1992, Manila
To facilitate the integration
of 11 priority sectors
To facilitate the
implementation of the
CEPT Agreement
To assist in the
formulation of measures
to realise the AEC
To realise the ASEAN
Free Trade Area (AFTA)
Agro-based
Air travel
Automotive
E-ASEAN
Fisheries
Electronics
Healthcare
Logistics
Textiles
Rubber
Tourism
Wood
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
Sectors
Electrical and electronics
- Electrical appliances
- Electrical safety
- Electromagnetic
compatibility
Corresponding
standards
Outcome of harmonization
ISO and IEC
139 harmonised standards
Rubber-based products
ISO
3 harmonised standards
Pharmaceuticals
International
Conference on
Harmonisation
Requirements (ICH)
ASEAN Common Technical
Dossiers (ACTD)
ASEAN Common Technical
Requirements (ACTR)
Harmonisation of technical
barriers to trade
Technical Regulations and MRAs
Technical Regulations
Electrical and
electronics
ASEAN Harmonised Electrical and Electronic
Equipment Regulatory Regime signed on 9
December 2005
Cosmetics
ASEAN Harmonised Cosmetic Regulatory
Scheme signed on 2 September 2003.
Mutual Recognition Arrangements
Electrical and
electronics
ASEAN Electrical and Electronic Mutual
Recognition Arrangement (ASEAN EE MRA)
signed on 5 April 2002
Cosmetics
ASEAN Mutual Recognition Arrangement of
Product Registration Approvals for Cosmetics
signed on 2 September 2003
Pharmaceuticals
Sectoral MRA on Good Manufacturing Practice
Standards
Harmonisation of technical
barriers to trade
Technical Regulations
Conformity Assessment Procedures
ASEAN Policy Guideline on Standards and
Conformance
-ISO/IEC Guide 21
-Annex 3 of the WTO/TBT Agreement
ASEAN Good Regulatory Practice Guide
Technical Regulations
Electrical and
electronics
ASEAN Harmonised Electrical and
Electronic Equipment Regulatory
Regime signed on 9 December
2005
Cosmetics
ASEAN Harmonised Cosmetic
Regulatory Scheme signed on 2
September 2003.
Mutual Recognition Arrangements
Standards
Sectors
Electrical and electronics
- Electrical appliances
- Electrical safety
- Electromagnetic
compatibility
Corresponding
standards
ISO and IEC
Outcome of harmonization
Electrical and
electronics
ASEAN Electrical and Electronic
Mutual Recognition Arrangement
(ASEAN EE MRA) signed on 5 April
2002
Cosmetics
ASEAN Mutual Recognition
Arrangement of Product
Registration Approvals for
Cosmetics signed on 2 September
2003
Pharmaceuticals
Sectoral MRA on Good
Manufacturing Practice
…….harmonised standards
Rubber-based products
ISO
3 harmonised standards
Pharmaceuticals
International
Conference on
Harmonisation
Requirements (ICH)
ASEAN Common Technical
Dossiers (ACTD)
ASEAN Common Technical
Requirements (ACTR)
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.
Prepared Foodstuff
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
Pharmaceuticals
ASEAN Common Technical Dossiers (ACTD)
ASEAN Common Technical Requirements (ACTR)
Medical Devices
ASEAN Common Submission Dossier for Medical Devices
Post-market surveillance
system
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.
Post marketing alert system for defective or unsafe medical device
ASEAN Conformity Mark
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
Capacity building
DIALOGUE PARTNERS
Australia - Strengthening Standards and Conformity Assessment for Cosmetics, EEE,
Pharmaceutical, Prepared Foodstuff
EC- Strengthening Standards and Conformity Assessment for Cosmetics, EEE, Pharmaceutical,
Prepared Foodstuff
Japan - Technical assistance in standards and conformance and TQM
NZ - Capacity Building in Legal Metrology for CLMV
USA - Healthcare Sector integration activities
DONOR AGENCIES
ITC - Capacity building on PMS and GMP for ASEAN Harmonised Cosmetic Regulatory Scheme
(AHCRS)
PTB - Technical assistance in implementation of AHCRS and Legal Metrology
World Bank - Technical assistance to CLMV in implementation of AHCRS
ACCSQ’S DECISIONS ON MRAs
25th Meeting of ACCSQ, 9-10 March 2005, Vientiane
…..agreed on basis of developments of ASEAN MRAs
…..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
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
…..an important means of eliminating technical barriers to trade
…..enhancing intra-ASEAN market access
Three sectoral MRAS have been developed
Electrical and
electronics
Cosmetics
Telecommunications
ASEAN EE MRA
…..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 HARMONIZED ELECTRICAL AND ELECTRONIC
EQUIPMENT REGULATORY REGIME
…..signed on
9 December 2005
….. eliminate restrictions
to trade of EEE in ASEAN
….. leading to a single
regulatory regime by 2010
…..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
ASEAN HARMONISED COSMETIC
REGULATORY SCHEME
Schedule A
Mutual Recognition Arrangement of Product
Registration Approval
Schedule B
ASEAN Cosmetic Directive
Schedule A: Mutual Recognition of Product Registration Approval
…..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
…..AMCs are committed to implement Schedule B by January 2008
ACTD
ASEAN Common Technical Dossiers
- covering administrative data, quality, safety and
efficacy
- marketing authorization application dossier that is
common to all AMCs
ACTR
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
Labelling
-Harmonization of labeling requirements for
pharmaceuticals has been completed
GMP
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 Food Control Requirements
ASEAN
Common
Principles and
Requirements for
the Labelling
of Prepackaged
Food
ASEAN
Common
Principles for
Food Control
Systems
ASEAN
Common
Principles and
Requirements
for Food
Hygiene
- Cosmetics
- Medical Devices and Equipments
- Pharmaceuticals
- Traditional Medicine and Health Supplements