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The Association of Southeast Asian Nations (ASEAN) was created in 1967 with the signing of the ASEAN Declaration by Indonesia, Malaysia, Philippines, Singapore and Thailand. Brunei Darussalam then joined in 1984, Viet Nam in 1995, Lao PDR and Myanmar in 1997, and Cambodia in 1999, arriving at the current number of ten Member States. These ten countries with a total land area of 4.5 million sq. km. are home to 660 million.

In 2003, ASEAN Heads of State agreed to establish an ASEAN Community by 2020, a community nations that is outward looking, living in peace, stability and prosperity, bonded together in partnership in dynamic development and in a community of caring societies. The ASEAN Community has three pillars, namely, the ASEAN Political-Security Community, the ASEAN Economic Community and the ASEAN Socio-Cultural Community.

ASEAN has identified harmonisation of national standards with reference to international standards, practices and guides; harmonisation of mandatory technical requirements to ensure free movement of goods; and harmonisation of conformity assessment procedures to save transaction time and to avoid high cost of multiple testing requirements, as ways to respond to the challenge of addressing technical barriers to trade in ASEAN while at the same time ensuring that the aims of having a system of standards and conformance (to promote greater efficiency and enhance cost effectiveness in the production of intra-regional imports/exports) are realised.

The ASEAN Economic Community (AEC) seeks to create ASEAN as a single market and production base and an economic region by 2020. However in 2007, ASEAN decided to accelerate the establishment of the AEC by 2015. This economic community is being created through regional integration of the following priority sectors, namely agro-based products, air travel, automotives, e-ASEAN, electronics, fisheries, healthcare, rubber-based products, textiles and apparels, tourism, wood-based products, logistics and such other sectors as may be identified by ASEAN for economic integration.

The healthcare sector includes pharmaceuticals, cosmetics, medical devices, traditional medicines and health supplements. 

For the traditional medicines and health supplements category under the healthcare sector, the output expected is the development of an ASEAN Agreement on Regulatory Framework for Health Supplements as well as an ASEAN Agreement on Regulatory Framework for Traditional Medicines, attached with respective annexes of harmonised technical requirements.  These regulatory frameworks are expected to be transposed into national laws of ASEAN Member States within 5 years after the signing and ratification of the agreements.For the health supplement category, the output expected is the development of an ASEAN Regulatory Framework on Traditional Medicines and Health Supplements and transposition of the ASEAN Regulatory Framework into national laws of ASEAN Member States.

The ASEAN bodies involved in the harmonisation of technical requirements on health supplements are as follows:

The Traditional Medicines and Health Supplements Product Working Group (TMHS PWG) officially formed in 2004 was tasked with overseeing the harmonisation of technical requirements on health supplements (and traditional medicines) for ASEAN. In most regions of the world, such harmonisation would be expected to take a long time to complete. The TMHS PWG, however, has set itself the challenging task of harmonising a set of technical requirements on health supplements by 2015, to be in line with the date of formation of AEC. This has been rescheduled for 2022 as a result of the complexities and challenges posed by the diverse existing regulatory regimes in the 10 ASEAN Member States.

Industry involvement in the harmonisation of health supplements in ASEAN is recognised under the ASEAN Charter and the ASEAN Policy Guideline on Standards and Conformance.

AAHSA, as the regional representative of the health supplement industry, has a seat at the table of the 10 ASEAN governments in the meetings of the Traditional Medicines and Health Supplements Product Working Group (TMHS PWG) as well as its subcommittees, ASEAN Traditional Medicines and Health Supplement Scientific Committee (ATSC) and ASEAN Traditional Medicines and Health Supplement GMP Taskforce. AAHSA also actively collaborated with ASEAN Member States and significantly contributed to the development of the various ASEAN harmonised technical guidelines for health supplements.

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