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Malaysia DRGD 12th Revision: Key Health Supplement Updates

Malaysia's NPRA has introduced a tiered registration fee structure for health supplements based on claim type and the number of active ingredients. The updated guidance also adds mandatory Vitamin B6 warning language for certain products and expands the list of permitted functional claims for selected ingredients such as L-carnitine, vitamin B2, and zinc.

On July 16, 2026, the National Pharmaceutical Regulatory Agency (NPRA) under the Ministry of Health Malaysia released a directive regarding the adoption of the Drug Registration Guidance Document (DRGD) Third Edition, 12th Revision July 2026. This newly revised guidance introduces critical updates specifically impacting health supplements, encompassing restructured registration fees, mandatory safety warnings, and expanded allowable functional claims. The updated regulations will officially take effect on July 31, 2026.

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