Asean Harmonization in the Regulation of Traditional Medicines and Health Supplements

Author

MADAM SALEHA MD EWAN
Head of Complementary and Veterinary Section
National Pharmaceutical Control Bureau
Ministrty of Health, Malaysia
Email:
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Language

English

Title

Asean Harmonization in the Regulation of Traditional Medicines and Health Supplements

Proceeding

7th INTRACOM – 2nd ICBWI 2009

Date

25th July 2009

Place Held

PWTC, Kuala Lumpur

Abstract

The Traditional Medicines and Health Supplements Product Working Group ( TMHS PWG) was formed in August 2004 under the ASEAN Consultative Committee for Standards and Quality (ACCSQ). This working group which  comprises of regulatory and industry representatives from 10 ASEAN member countries namely Brunei Darussalam, Cambodia, Indonesia (Chair), Lao People’s Democratic Republic, Malaysia (Co Chair),Myanmar, Philippines,  Singapore , Thailand and Vietnam, was tasked to develop a harmonization working scheme among member countries to facilitate and complement the objectives of the ASEAN Free Trade Area, without compromising on quality ,safety and efficacy. Since its inception about 5 years ago, the TMHS  PWG has had 10 meetings and has been heavily involved in several activities towards achieving its goal including preliminary exchange of information related to existing regulatory requirements and comparative studies of TMHS regulation in countries worldwide. With the involvement of ASEAN Alliance of  Health Supplements Association (AAHSA ) , ASEAN Alliance of  Traditional Medicines Industries (AATMI) and The ASEAN Technical Scientific Committee (ATSC) in the PWG, various guidelines are being developed related to ASEAN Common Technical Requirements and Dossier (ACTR/ACTD) based on wide consultations and consensus agreement of member countries.

Keywords

Traditional Medicine, Health Supplements

Session

Symposium 4A-1

Topic

Quality and Safety of TCM Products