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The implementation of the Food and Drug Administration to support the ASEAN integration

 

 

 

 

 

 

 

 

 

        The FDA is mainly responsible for product category working group under the ASEAN Consultative Committee on Standards and Quality (ACCSQ). To facilitate trade, regulation and law, ACCSQ committee has appointed the following five product working groups:

1. Pharmaceuticals Product Working Group (PPWG).

PPWG objectives are adjustment of rules and procedures of pharmaceutical products, supporting for drug registration, trade and cooperation in the region, and elimination of any Technical Barrier to Trade (TBT) among ASEAN members according to plan and schedule. FDA representative has also served as Co-Chairman in working group.

2. Traditional Medicines and Health Supplement Product Working Group (TMHSPWG)

TMHSPWG objectives are harmonization and implementation of rules, certification of traditional medicine and health supplement product among ASEAN members.  It also appoints sub-working groups to facilitate its goals, which are the ASEAN TMHS Scientific Committee (ATSC) and the Task force on TMHS GMP.

3. ASEAN Medical Device Committee (AMDC)


AMDC objectives are overall responsibility of coordinating, reviewing and monitoring the implementation of ASEAN Agreement on Medical  Device Directive (AMDD) and reduction of trade barriers due to regulatory and technical measures. At the same time, it can confidently protect consumers, to ensure the quality, efficiency and safety of medical devices.

4. Prepared Foodstuff Product Working Group (PFPWG)

PFPWG  aims to eliminate technical barriers to trade for prepared foodstuff products by:

     1. Exchange information regarding rules, procedures and regulations among member states.

     2. Review, analyze and compare the regulatory mechanisms between the member state

     3. Set up area of cooperation and mutual recognition (MRA), develop, implement, and monitor the joint Sectoral MRA.

     4. Establish technical infrastructure and ensure joint confidence in testing and evaluation for certification.

 

5. ASEAN Cosmetic Committee (ACC)


              ACC objectives are adjustment of  rules and regulations about cosmetic products in ASEAN, promotion and facilitation of trade, and making imports and exports faster. It has to correspond to the Agreement on the ASEAN Harmonized Cosmetic Regulatory Scheme (AHCRs).

              The essence of this agreement is to use the same standard regulations for cosmetic products in ASEAN.   By adapting the regulations, cosmetic entrepreneur must declare product details before sending out to the market. ASEAN member countries must implement the provisions of the ASEAN Cosmetic Directive since 1 January 2551 onwards. These regulations will reduce the pre-market monitor and emphasis in the post-market monitor instead. Thailand must enforce this new regulations and change related internal law and regulations. In addition, entrepreneur has to provide necessary information for the safety of cosmetic products and be ready to show them to the authority at its manufacturing location.