Malaysia: NPRA Updates Drug Labeling Requirements for Animal-Derived Ingredients

The National Pharmaceutical Regulatory Agency (NPRA) recently released an update of the Drug Registration Guidance Document (DGRD) to mandate the declaration of animal-sourced ingredients on product labels. This directive is especially relevant for pharmaceuticals, traditional medicines, and health supplements.

As referenced in Appendix 19 of the DRGD, it is required to disclose animal-derived components, including active ingredients, excipients, and starting materials like gelatin. Nowadays, animal-sourced ingredients may also be present in components beyond active ingredients and excipients, such as primary packaging materials, further emphasizing the importance of this labeling requirement.

On 1 August 2024, the Drug Control Authority (PBKD) agreed to update the DRGD to clarify the declaration requirements as follows:

To declare the source of ingredients derived from animal origin, unless a satisfactory confirmation can be provided verifying the absence of animal materials in the final product

Therefore, all product registration holders are required to ensure that all product labels comply with the latest guidelines, especially if any components contain materials sourced from animals.

This requirement will take effect immediately from the date of this circular.

Source: National Pharmaceutical Regulatory Agency (NPRA)