Malaysia Approves First Natural Product with Modern Claim

On October 8, 2024, Malaysia's Ministry of Health (MOH) announced the approval of the natural product Nova Hepar-P Capsule with a modern claim for liver health support. This marks the first registration of a natural product with a modern claim, following the country's policy change in April 2024.

In Malaysia, health supplements and natural products are classified as medicinal products. Previously, natural products could only bear traditional claims (e.g., relieving mild symptoms) and therapeutic claims (e.g., helping with the treatment of a disease). In April 2024, the National Pharmaceutical Regulatory Agency (NPRA) introduced new guidelines allowing products to be registered with modern claims from April 4, 2024, provided they meet specific evidence requirements.

According to the media statement, Nova Hepar-P Capsule, developed by Nova Laboratories Sdn. Bhd., contains aerial Phyllanthus niruri, standardized to include 4% Corilagin and 18% Phyllanthus Flavonoids. The modern claim for liver health support was substantiated by local clinical studies, and safety was confirmed through toxicity studies and over 20 years of usage history.

For further details, refer to this media statement and ChemLinked’s previous report: Malaysia Allows Registration of Natural Products with Modern Claims from April 4, 2024.