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ASEAN Initiatives Towards Harmonization of Traditional Medicines and Health Supplements

ASEAN Initiatives Towards Harmonization of Traditional Medicines and Health Supplements. Seminar on Control of Quality and Safety of Traditional Medicines and Health Supplements – Current Trend. Presentation Outline. Background Roadmap for ASEAN Healthcare Integration

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ASEAN Initiatives Towards Harmonization of Traditional Medicines and Health Supplements

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  1. ASEAN Initiatives Towards Harmonization of Traditional Medicines and Health Supplements Seminar on Control of Quality and Safety of Traditional Medicines and Health Supplements – Current Trend

  2. Presentation Outline • Background • Roadmap for ASEAN Healthcare Integration • Establishment of ACCSQ Product Working Group on Traditional Medicines and Health Supplements • Action Plan

  3. Background • ACCSQ formed by ASEAN Economic Ministers in 1992 with the aim of removing technical barriers to trade in order to facilitate the implementation of the Common Effective Preferential Tariff (CEPT) Agreement to realize the ASEAN Free Trade Area (AFTA). • In 1997, Senior Economic Officials Meeting (SEOM) authorized the involvement of regulatory bodies. • Decision of ASEAN Leaders on the establishment of ASEAN Economic Community (AEC) by 2020. • Fast track integration of 11 priority sectors including healthcare. • Special SEOM in August 2004 approved the formation of product working group to implement measures on traditional medicines and health supplements under the healthcare integration roadmap.

  4. Integration of ASEAN Healthcare • Healthcare sub-sectors - Pharmaceuticals, Traditional Medicines and Health Supplements (TM & HS), Cosmetics and Medical Devices (MD). • Efforts to harmonize Pharmaceuticals and Cosmetics in progress. • Need for new PWG for TM & HS and MD. • Possibility of separating TM & HS later.

  5. ROADMAP FOR TM & HS

  6. ROADMAP FOR TM & HS

  7. Objectives and Scope • Assists the ACCSQ in implementing specific measures to facilitate the integration of traditional medicines and health supplements in ASEAN. • Exchange, review and analyze information on the existing regulatory framework/regime including standard definition, terminologies and technical infrastructure. • Study existing regulatory frameworks/regime of selected countries and internationally accepted technical guidelines. • Enhance the technical infrastructure including mutual confidence in testing and conformity assessment. • Identify areas for possible harmonization and MRAs.

  8. Action Plan • Goals • Overall goal – Elimination of TBT for TM & HS among ASEAN • PWG goal – ASEAN MRA for TM & HS • Objectives • Consensus on specified area of regulatory regime for MRA • Harmonization of regulatory scheme of product placement • Strengthening technical infrastructure • Strategies

  9. Strategies • Objective 1 • Exchange of information • Review of regulatory frameworks • Agree on specified area • Objective 2 • Review of technical requirements for product placement • Select acceptable regulatory scheme • Identify common technical key areas • Objective 3

  10. Objective 3 • Implement program to improve technical infrastructure and capacity building • Establish Post marketing alert system • Amend national legislation • Cooperate with international organizations

  11. Thank You

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