????????????????????????? 26.2.1 CASCO Forum ???????? 1/2551

1
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?? 6?

• ????????????????????????? 26.2.1 CASCO Forum
  ???????? 1/2551
• ???????????? 30 ?????? 2550
• ???? 09.00-15.00 ?. ? ?????????? 200 ???.

2
ASEAN 2510
Association of South East Asian Nations
?????????????? ?????????????????????????? ????
???????
3
ASEAN 2550
ASEANs 40th Anniversary, 8 August 2007
4
ASEAN 10
TEN NATIONS, ONE COMMUNITY
2510 ??????????? ???????? ??????????
???????? ???
2527 ???????????????
2538 ????????
2540 ??? ??? ????
2542 ???????
5
ASEANs Goal
1. ???????????????????????????????????????????????
?????? ????????????? ????? ???????? ?????????
??????????? ???????????? 2.
??????????????????????????????????????????? 3.
??????????????????????????????????????????????????
????? ???????????????????? 4.
??????????????????????????????????????????????????
?? 5. ????????????????????????????????????????????
????????????????????? 6. ?????????????????????????
???????????????????
6
AFTA 2535
ASEAN FREE TRADE AREA
????????????????????
??????????????????????????????????????????????????
?????????????????? (???????? CEPT)
?????????????????????????? ???????????????????? ??
??????????????????????????????????????????????????
???????? 0-5 ????????????????????????????????????
????? 5 ?????????????
7
ASEAN Community 2545
ASEAN Security Community - ASC
ASEAN Economic Community - AEC
ASEAN Socio-Cultural Community - ASCC
ASEAN COMMUNITY 2563
8
AEC 2546
ASEAN ECONOMIC COMMUNITY
??????????????????????
single market and single production base
free flows of goods, services, investment, and
skilled labors, and freer flow of capital
9
11 ROADMAP(1) 2547
11 Priority Integration Sectors

• ???????????????????????????????????
• ???????????????????????
• ??????????????????????????????????
• ???????????????????
• ?????????????????????????
• ????????????????????????
• ????????????????????
• ????????????????????????????????
• ?????????????????????????????????

??????????? ???????????? ???????
???????? ???????????? ??????
???? ?????????????? ??????????????
?????????? ??????????????
???????? ?????????? ?????????????????
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10
11 ROADMAP(2) 2549

• The ASEAN Framework Agreement (Amendment) for the
  Integration of Priority Sectors
• The Amended Protocol for the Integration of
  Priority Sectors
• The ASEAN Trade Facilitation Work Programme
  (ATFWP)

11
AEC Blueprint 2550
2563 (2020)
2558 (2015)

Single Market and Production Base
High Competitive Economic Region
Equitable Economic Development
Fully Integrated into Global Eco.
??????????????????? ???????????????????? ??????
???????? ?????? ?????????? ???????????? ?????????
?????
??????????????????? ??????????????? ?????????
???? ???????????????? ????????????????? e-commerc
e
??????????????????? ?????????????? ????????? ?????
???????? ????????????? ?????????????
??????????????????? ?????????????? ??????????
????????????? ????????????????? ???????/???????
12
ASEAN Charter 2550
ASEAN Charter
?????????????
????????????????? (rule-based organization) ??????
???????????????? (people-centered
organization) ????????????????????????? -
???????????? ?????????????? ??????????????????
13
13th ASEAN Summit
18-22November 2007 in Singapore
AEC Blueprint
ASEAN Trade Facilitation Work Programme
ASEAN Charter
14
ASEAN Structure
ASEAN Summit
ASEAN Finance Ministers Meeting (AFMM)
ASEAN Economic Ministers (AEM)
Others
ASEAN Ministerial Meeting (AMM)
Dialogue Partners
Australia Canada China EU India Japan New
Zealand Korea Russian US UNDP
ASEAN Standing Committee (ASC)
Senior Officials Meeting (SOM)
Committees
Senior Economic Officials Meeting (SEOM)
ASEAN Senior Finance Officials Meeting (ASFOM)
ASEAN Consultative Committee for Standards and
Quality (ACCSQ)
Sub-Committees Working Groups
Working Groups
Working Groups
15
ACCSQ 2535
??????????????????? ??????????????????????????????
ASEAN Consultative Committee for Standards
and Quality

• ??????????????????????????????????? ??????????
  ???????????????????????? ????????? (TBT)
  ????????????????? ????????? ?????????
  ???????????????????
• ?????????/????????????????????????
  ??????????????????? FTA ??????????
  ?????????????????
• ?????????????????????????????????????????????
  ??????? ?????????????????? ??? ????????????????

16
IPS Agreement 2549
Article 7 Standards and Conformance under ASEAN
Framework Agreement (Amendment) for the
Integration of Priority Sectors
1. ???????????????????????? MRA ??????? ????????
1 ?????? 48 2. ??????????????????????????????????
???????????????????????? ????????????????????
????????????????????????????????????
???????????????????????????????????????? ILAC ???
APLAC ???????? 1 ?????? 2550 3.
??????????????????????????????????????????????????
?????????? ??????????????????????????????????
??????????????????????????? ?????????????
??????????????????????????????????????????????
??????????????????????????????? ????? 31
??????? 2548 4. ?????????????????????????????????
????????????????? ????? 31 ?.?. 50
17
IPS Agreement 2549
Article 7 Standards and Conformance under ASEAN
Framework Agreement (Amendment) for the
Integration of Priority Sectors
5. ??????????????????????????????????????????????
????? ????? 31 ?.?. 53 6. ???? ???/????
?????????????????????????????????
??????????????? ??????????? ????? 31 ???????
2553 7. ????????????????????????????????????????
?????? WTO TBT ??? SPS 8. ???????????????????????
????????????????????? ???????????????????
??????????????????????????????????????????????????
? ??????? 2548
18
AEC Blueprint 2550
19. ???????????????????????????????????
??????????? ?????? ????????? ????????????????
??????????????????????????????????????????????????
?????? ???????????????????????????????????????????
?/?????????????????? ????????? ??????????????
?????????????????? ???????????????????????????????
?????????????????????????????????????????????????
??????????????? ??????????????????????????????
??????????????????????????????????????
????????????????????????????????????
???????????? 1. ??????????? ??????????????????
???????????????????????????????
??????????????????????????????????????????????????
??? 2. ?????????????????????????????????????????
(MRAs) ???????????? ??????????????????????????
???????????????????????????????????????
??????????????
19
AEC Blueprint 2550
3. ???????????????????????????????????????????????
????????????????????? ????? ???????????
??????? ????????? ??????????????????? ??????
????????????????????????????????????????????????/?
?????????????? 4. ???????????????????????????????
???????????????????? ????????????
???????????????????????????????????????????
????????????????????? ????????????????????????
?????????????????? WTO ????????????????
????????????????????????????? 5.
??????????????????????????????????????????????????
?????? ???????? ??????????????????????????????
?????????????????????????????????????????
???????? 6. ???????????????????????????????????
????????????????????????????????
????????????????????????
20
12 WGs/PWGs

Joint Sectoral Committee (JSC) for ASEAN
EEE Agreement
Product Working Group on Prepared Foodstuff
Product Working Group on Pharma- ceutical
WG 1 on Standards and Mutual Recognition Arrangem
ent
WG 2 on Accreditation and Conformity Assessment
ASEAN Cosmetic Committee (ACC)
WG 3 on Legal Metrology
Product Working Group on Medical Device and
Equipment
Product Working Group on Traditional Medicines
Health Supplement
Product Working Group on Rubber- based Products
Product Working Group on Wood- based Products
Product Working Group on Automotive
21
24 Chairs Co-Chairs
???????? ??????
?????????? WG 1 ???????? ????? WG
2 ???????? ???????? WG 3
???????? ??????????? JSC EE
MRA ???????? ????? ACC ???????????
??? PWG on Pharmaceutical
???????? ??? PWG on Prepared
Foodstuff ??????????? ??? PWG on
Automotive ??????????? ??? PWG on
Rubber-based products ???????? ??? PWG on
Wood-based products ??????????? ???????? PWG
on Traditional Medicine ???????????
???????? PWG on Medical Device ????????
????????
22
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

23
Harmonisation of technicalbarriers to trade
(technical regulations MRA)
24
Harmonisation of technicalbarriers to trade
Standards
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
25
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
26
Post-market surveillancesystem
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
27
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
28
MRAs IN ASEAN
29
ACCSQS 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
30
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.
31
ASEAN Framework Agreement on Mutual Recognition
Arrangements
..signed on 16 December 1998
..general principles for developing sectoral MRAs
..an important means of eliminating TBT
..enhancing intra-ASEAN market access
Three sectoral MRAS have been developed
Electrical and electronics
Cosmetics
Telecommunications
32
ELECTRICAL AND ELECTRONICS SECTOR
33
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
34
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
35
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
36
COSMETICS SECTOR
37
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

38
ASEAN HARMONISED COSMETIC REGULATORY SCHEME
Schedule A
Mutual Recognition Arrangement of Product
Registration Approval
Schedule B
ASEAN Cosmetic Directive
39
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
40
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
41
PHARMACEUTICALS SECTOR
42
ASEAN Common Technical Dossiers - covering
administrative data, quality, safety and
efficacy - marketing authorization application
dossier that is common to all AMCs
ACTD
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.
43
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

44
PREPARED FOODSTUFF SECTOR
45
ASEAN Common Food Control Requirements
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
46
Other Sectors
Automotive
- Cosmetics
Healthcare
- Medical Devices and Equipments
- Pharmaceuticals
- Traditional Medicine and Health Supplements
Rubber-based products
Wood-based products
47
ACCSQ - Partners

• ASEAN Standards and Conformance Cooperation
  Program
• ASEAN-Japan Standards and Conformance E-Center

JAPAN

• The EC-ASEAN Economic Cooperation Programme on
  Standards, Quality and Conformity Assessment
• Trans-Regional EU-ASEAN Trade Initiative
  (TREATI)
• ASEAN Programme for Regional Integration Support
  (APRIS)

EC
CER

• MOU on Standards and Conformance
• ASEAN-Australia Development Cooperation
  Programme (AADCP)
• New Zealand Metrology Cooperation

• MOU on Trade related Standards and Conformance
  Issues
• ASEAN-US Enhanced Partnership (AEP)

US

• Framework Agreement on Comprehensive Economic
  Cooperation
• Among ASEAN and Korea

KOREA

• ASEAN-China Proposal on Contact Point and
  Priority Cooperation Areas on Standardization

CHINA
48
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