Malaysia's National Pharmaceutical Regulatory Agency (NPRA) has released the Drug Registration Guidance Document (DRGD) Third Edition, 12th Revision (July 2026), introducing significant updates for health supplements. The revised guidance, issued on 16 July 2026 and effective from 31 July 2026, includes changes to registration fees, mandatory safety labelling requirements, and permitted functional claims. A key change is the introduction of a tiered registration fee structure for health supplements, with fees varying according to the type of claims made and the number of active ingredients in the product. The revision is intended to better align regulatory oversight with product complexity and claim profiles. The updated guidance also introduces mandatory warning statements for products containing Vitamin B6, reinforcing consumer safety measures related to excessive intake. In addition, NPRA has expanded the list of permitted functional claims for selected ingredients, including L-carnitine, vitamin B2 (riboflavin), and zinc, providing manufacturers with greater flexibility in product positioning while maintaining regulatory compliance. Health supplement manufacturers, importers, and product registration holders should review the revised DRGD requirements and assess their product portfolios, labelling, and registration strategies to ensure compliance before the new provisions take effect on 31 July 2026.
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