Bio: A medical doctor, with MSc in Clinical Pharmacology and PhD in Pharmacometrics, an accomplished researcher and senior health official in the Ministry of Health Malaysia.

l Previous Head of Herbal Medicine Research Centre (2014–2024), previous manager of IMR’s in vivo GLP-certified laboratory (2019-2025), and ex-chairman of key national committees such as the Malaysian Herbal Monograph and the Technical Committee for the National Research and Development of Herbal Medicine (NRDHM) (2013-2024) and led the development of Malaysia’s national “Guideline for Herbal Medicine Research” launched in 2023.

l Current chairman of the Preclinical & Clinical Herbal Research Clusters (since 2014).

l Member of the Medical Research and Ethics Committee since 2014 (deputyship in 2022-2024) and a member of the Scientific Review Panel for Phase I First-in-Human studies since 2018.

Abstract: Malaysia’s rich heritage of herbal medicine and the increasing consumption of dietary supplements and herbal products have necessitated the development of a comprehensive safety framework. This presentation outlines Malaysia’s dual approach to ensure the safety and quality of herbal and dietary products through scientific evaluation and regulation. Herbal medicines are regulated by the National Pharmaceutical Regulatory Agency (NPRA), focusing on product standardization, toxicological assessments, and efficacy evaluations at more than a single level of evidence, for product registration. Dietary supplements, particularly those classified as food products, fall under the purview of the Food Safety and Quality Division (FSQD) of the Ministry of Health Malaysia, with emphasis on food safety principles, ingredient limits, and labelling requirements. Post-marketing surveillance activities, such as the monitoring of adverse drug reactions (ADRs), are conducted to identify and mitigate potential safety concerns. This presentation will discuss the integration of traditional knowledge with modern regulatory practices, highlighting challenges and opportunities in safeguarding public health. The Malaysian experience offers a potential model framework to strengthen regulatory and scientific oversight of herbal and dietary products in line with international best practice standards.