Public Consultation on the Proposed ASEAN Agreement on Traditional Medicines and ASEAN Agreement on Health Supplements
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:
- 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.
TMHSPWG, comprising of regulators and key industry associations from ASEAN Member States (AMS), has been working on the ASEAN Agreements on Traditional Medicines and Health Supplements and its annexed technical guidelines since 2004. The two separate draft Agreements, viz. the ASEAN Agreement on Traditional Medicines and the ASEAN Agreement on Health Supplements (collectively as AATMHS) that were endorsed in August 2014 are now ready for national consultation.
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.
HSA welcomes your comments and feedback on the AATMHS and its Annexes.
Please provide your name, the organisation you represent, mailing address, contact number and email address to enable us to follow up with you to clarify any issues, if necessary.
Where possible, you should highlight the provisions in the proposed draft of the Agreements or the Annex for which you are providing comments on.
Please note that the contents of any written feedback submitted, and the identity of the source, may be disclosed at the conclusion of this consultation. You may request for the feedback provided to be treated with confidence on grounds that the information is proprietary, confidential or commercially-sensitive. Such requests will be taken into consideration.
Period of Consultation
The consultation period is from 3 December 2014 to 7 January 2015.
The consultation is now closed.
These draft agreements and annexes as listed below. Please be informed that they are released only for the purpose of consultation and does not represent the final agreements and annexes.
A. ASEAN Agreement on Traditional Medicines
B. ASEAN Agreement on Health Supplements
C. Annex I – ASEAN Guiding Principles for Inclusion into or Exclusion from the Negative List of Substances for Traditional Medicines and Health Supplements
D. Annex II – ASEAN Guiding Principles for the Use of Additives and Excipients in Traditional Medicines and Health Supplements
E. Annex III – ASEAN Guidelines on Limits of Contaminants for Traditional Medicines and Health Supplements
F. Annex IV – ASEAN Guidelines for Minimising the Risk of Transmission of Transmissible Spongiform Encephalopathies in Traditional Medicines and Health Supplements
G. Annex V – ASEAN Guidelines on Stability and Shelf-Life of Traditional Medicines and Health Supplements
H. Annex VI – ASEAN Guiding Principles on Safety Substantiation for Traditional Medicines and Health Supplements
I. Annex VII – ASEAN Guidelines on Claims and Claims Substantiation for Traditional Medicines and Health Supplements
J. Annex VIII – ASEAN Guidelines on Good Manufacturing Practice for Traditional Medicines and Health Supplements
K. Annex IX – ASEAN Guidelines on Labeling Requirements for Traditional Medicines and Health Supplements
L. Annex X – ASEAN General Principles for Establishing Maximum Levels of Vitamins and Minerals in Health Supplements
Conclusion of Consultation
A total of 56 feedbacks were received from the stakeholders. 40 feedbacks were related to the TM and HS scope and the ASEAN technical standards and guiding principles. 16 feedbacks on the national arrangements such as the implementation of the ASEAN harmonised requirements in Singapore.
HSA has reviewed and considered each feedback and comment on the proposed AATMHS and its Annexes. Where necessary, HSA has surfaced the feedbacks to the TMHS Product Working Group for discussion and clarifications.
HSA would like to thank all stakeholders who had participated in the consultation.