Update on Analytical Testing and Labelling Declaration Requirements for Products Containing Animal-Derived Materials

Drug Control Authority (DCA) approved updated policies concerning products containing animal-derived materials through Circular NPRA.600-1/9/12 (31).

This update introduces a risk-based approach for scientific justification and aligns labelling requirements with international regulatory standards.

Revocation of Previous Circulars

The new directive replaces and revokes the following circulars:

• NPRA.600-1/9/12 (20)
• NPRA.600-1/9/12 (25)

Risk-Based Justification Approach

For the manufacturing of drug substances:

• Validated DNA testing on the final product is no longer required
• Scientific justifications are accepted

These justifications may include:

• Manufacturer declarations
• Detailed purification process data demonstrating removal of animal-derived materials

Exemption of Primary Packaging

Animal-derived materials used in primary packaging are no longer included within the scope of evaluation or mandatory declaration requirements.

Mandatory Labelling Requirements

For drug products, it remains mandatory to declare the specific animal source for all ingredients used in the final product.

This includes:

• Active substances
• Excipients
• Preservatives
• Capsules

Supplementary DNA Statements

If DNA testing is conducted and results are negative, an additional statement may be included on the outer carton.

Example:
“PORCINE ORIGIN. No traces of porcine DNA found in the final product.”

Effective Date

These updated requirements are effective immediately from 16 March 2026.

They apply to:

• All new product registration applications
• Products currently under evaluation

Reference Documents

Further details are available in:

• Circular NPRA.600-1/9/12 (31)
• FAQs on General Labelling Requirements (DRGD Appendix 19) for Products Containing Animal-Derived Materials

For more information: Update on Analytical Testing and Labelling Declaration Requirements for Products Containing Animal-Derived Materials

Supporting Regulatory Processes (Different Style)

Evolving requirements for product composition and labelling highlight the importance of aligning manufacturing data, documentation, and regulatory submissions with updated expectations.

Structured regulatory processes support accurate declaration practices and consistency across product dossiers. Explore Baupharma regulatory services via:
https://www.baupharma.com/services-categories/regulatory-affairs/#Regulatory-affairs-services