As part of ASEAN Vision 2020 adopted by the ASEAN Leaders to create a stable, prosperous and highly competitive ASEAN economic region, the ASEAN Leaders agreed on the accelerated establishment of an ASEAN Community by 2015. One of the pillars of the ASEAN Community is the ASEAN Economic Community (AEC). In 2004, under the umbrella of AEC, the Product Working Group for Traditional Medicines and Health Supplements (TMHSPWG) was established. Reporting to ASEAN Consultative Committee on Standards and Quality (ACCSQ) and with the assistance of the ASEAN TMHS Scientific Committee (ATSC), the ACCSQ TMHSPWG is tasked with: • Implementing measures for the integration of traditional medicines and health supplements stipulated in ASEAN Healthcare Integration Roadmap, • Harmonising technical requirements and explore possible Mutual Recognition Arrangements, • Eliminating technical barriers to trade for TM and HS, without compromising public health and safety to the ASEAN peoples. For information on ASEAN cooperation on standards and conformance to facilitate trade in the region, As part of ASEAN Vision 2020 adopted by the ASEAN Leaders to create a stable, prosperous and highly competitive ASEAN economic region, the ASEAN Leaders agreed on the accelerated establishment of an ASEAN Community by 2015. One of the pillars of the ASEAN Community is the ASEAN Economic Community (AEC). In 2004, under the umbrella of AEC, the Product Working Group for Traditional Medicines and Health Supplements (TMHSPWG) was established. Reporting to ASEAN Consultative Committee on Standards and Quality (ACCSQ) and with the assistance of the ASEAN TMHS Scientific Committee (ATSC), the ACCSQ TMHSPWG is tasked with: • Implementing measures for the integration of traditional medicines and health supplements stipulated in ASEAN Healthcare Integration Roadmap, • Harmonising technical requirements and explore possible Mutual Recognition Arrangements, • Eliminating technical barriers to trade for TM and HS, without compromising public health and safety to the ASEAN peoples. For information on ASEAN cooperation on standards and conformance to facilitate trade in the region, please clickhere. ASEAN GUIDELINES The following ASEAN Guidelines have been developed by the TMHS PWG. Please click on the respective links for more information. ASEAN Guiding Principles for Inclusion into or Exclusion from the Negative List of Substances for Traditional Medicines and Health Supplements ASEAN Guiding Principles for the Use of Additives and Excipients in Traditional Medicines and Health Supplements ASEAN Guidelines on Limits of Contaminants for Traditional Medicines and Health Supplements ASEAN Guidelines for Minimising the Risk of Transmission of Transmissible Spongiform Encephalopathies in Traditional Medicines and Health Supplements ASEAN Guidelines on Stability and Shelf-Life of Traditional Medicines and Health Supplements ASEAN Guiding Principles on Safety Substantiation for Traditional Medicines and Health Supplements ASEAN Guidelines on Claims and Claims Substantiation for Traditional Medicines and Health Supplements ASEAN Guidelines on Good Manufacturing Practice for Traditional Medicines and Health Supplements ASEAN Guidelines on Labeling Requirements for Traditional Medicines and Health Supplements ASEAN General Principles for Establishing Maximum Levels of Vitamins and Minerals in Health Supplements Reference:http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Complementary_Health_Products/Overview/ASEAN_Harmonization_of_Traditional_Medicines_and_Health_Supplements.html Public Consultation on the Proposed ASEAN Agreement on Traditional Medicines and ASEAN Agreement on Health Supplements ntroduction As part of ASEAN Vision 2020 adopted by the ASEAN Leaders to create a stable, prosperous and highly competitive ASEAN economic region, the establishment of ASEAN Economic Community (AEC) by 2015 is the goal of the regional economic integration. Healthcare sector is one of the twelve priority integration sectors identified for economic integration under AEC. The ASEAN healthcare sectoral programme includes initiatives in harmonising standards and conformance for various healthcare products. The ASEAN Agreements on Traditional Medicines and Health Supplements are anticipated to be signed in November 2015. In 2004, under the umbrella of AEC, the Product Working Group for Traditional Medicines and Health Supplements (TMHSPWG) that reports to the ASEAN Consultative Committee for Standards and Quality (ACCSQ) was established to look into the following:
Essential Components of AATMHS The AATMHS specifies the harmonised technical guidelines to be applied, where relevant, by AMS for the control of TM and HS including - i. Harmonised definition and scope of TM and HS ii. Standards and guiding principles, as annexed to the AATMHS, for the assurance of product safety, quality and intended benefits The AATMHS also requires the implementation of post market surveillance to handle early warning of any adverse events and/or other product safety issues that may occur, and appropriate measures for ensuring consumer safety. Reference:http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Complementary_Health_Products/Overview/ASEAN_Harmonization_of_Traditional_Medicines_and_Health_Supplements/public-consultationonproposedaseantmhsagreements.html
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