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This application is a service of the Singapore Government.

Health Sciences Authority

ASEAN Harmonization of Traditional Medicines and Health Supplements

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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 click here.

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

PUBLIC CONSULTATION

The Health Sciences Authority had conducted a public consultation, on the final drafts of the ASEAN Agreement on Traditional Medicines and the ASEAN Agreement on Health Supplements from 3 December 2014 to 7 January 2015.

Details on the consultation can be found here.