The Drug Control Authority (DCA) has approved updated policies regarding animal-derived materials for all product categories via Circular NPRA.600-1/9/12 (31). This update introduces a risk-based approach for scientific justifications and aligns labelling requirements with international regulatory standards.

Key Highlights:

• Revocation of Previous Circulars: This new directive officially supersedes and revokes circulars NPRA.600-1/9/12 (20) and NPRA.600-1/9/12 (25).
• Shift to Risk-Based Justification: For the manufacturing of Drug Substances, validated DNA testing on the final product is no longer mandatory. NPRA now accepts scientific justifications, such as manufacturer declarations or detailed purification process data, to demonstrate the removal of animal-derived elements.
• Exemption of Primary Packaging: The scope of evaluation and mandatory declaration no longer includes animal-derived materials used in primary packaging.
• Mandatory Labelling for Drug Products: Declaration of the specific animal source for all ingredients used in the final drug product (including active substances, excipients, preservatives, and capsules) remains mandatory on the label.
• Supplementary DNA Statements: If a manufacturer conducts DNA testing that yields negative results, a supplementary statement (e.g., "PORCINE ORIGIN. No traces of porcine DNA found in the final product") is permitted on the outer carton for transparency
• Immediate Effective Date: These requirements are effective immediately (as of 16 March 2026) for all new product registration applications and products currently under evaluation.

Reference Documents:

For detailed guidance, please refer to the following:

1. Circular NPRA.600-1/9/12 (31)

2. FAQs on General Labelling Requirements (DRGD Appendix 19) for Products Containing Animal-Derived Materials

Thank you.