Harmonising Regulation of Traditional Medicines and Health Supplements Ahead of ASEAN Integration
SINGAPORE, 14 April 2014 – Traditional medicines have been around for centuries, but the rise in demand for alternative and holistic medicines has generated more attention to the effects, classification, and production of these treatments and their close kin - dietary supplements. With the advent of the integrated ASEAN Economic Community in 2015, adopting consistent standards for these products in the region will be important. The best way to regulate the production and control of these products was the focus of a workshop on traditional medicines and dietary supplements, conducted in Singapore on 7-8 April.
As one of the activities that seeks to contribute to the development of the ASEAN Good Manufacturing Practice (GMP) guidelines, the workshop was designed to provide attendees with a sound understanding of the classification and regulation of dietary/health supplements.Ms. Lee Hui Keng, Assistant Group Director, Audit and Licensing, Health Products Regulation Group (HPRG), Health Sciences Authority of Singapore officially opened the workshop. In her opening remarks, Ms. Keng said that “the adoption of Good Manufacturing Practices helps to ensure that products are consistently produced and controlled according to quality management systems, minimising risks such as unintended contamination of products. The investment in implementing Good Manufacturing Practices is an investment in good quality products and more importantly, its ensures that health products remain safe for consumers to use.”
While health supplements may be classified and regulated as food in some countries, they may be classified and treated as pharmaceuticals in others. In comparison, the United States treats health supplements similar to dietary supplements, which are regulated as a category of food under the Dietary Supplement Health and Education Act of 1994 (DSHEA). The United States does not have regulations for traditional medicines, as they may be classified as either dietary supplements or pharmaceuticals, depending on the ingredients and any claims involved.
“The health supplements industry in the United States is a $35 billion and growing industry and its an important industry and growing industry in ASEAN countries as well. Increasing demand from consumers in both markets for products that are safe and of the highest quality provides a unique opportunity to share regulatory practices and experiences,” said Simon Kim of the U.S. Department of Commerce in his welcoming remarks.
The training was conducted by two experts in U.S. regulations governing dietary and health supplements. Around 50 participants, comprised of ASEAN regulators responsible for traditional medicine and dietary supplements as well as private sector representatives attended the workshop. It was a collaboration between the U.S. Department of Commerceand the ASEAN Traditional Medicines and Health Supplements Working Group (TMHSWG) and supported by the U.S. Agency for International Development ASEAN Connectivity through Trade and Investment (ACTI) Project.