On March 16, 2026, Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) issued an official circular updating the regulatory requirements for products containing animal-derived ingredients. The new policy revises previous requirements regarding analytical testing and labeling declarations and reflects decisions adopted during the 418th Drug Control Authority (DCA) Meeting held on March 5, 2026.
Background and Purpose
This circular replaces two previous regulatory notices and aims to align current requirements with the latest regulatory decisions concerning products containing materials derived from animal sources.
Key Regulatory Updates
The revised requirements can be summarized into three major changes:
1. Mandatory DNA Testing Requirement Removed
For products that utilize animal-derived materials during the active pharmaceutical ingredient (API) manufacturing process, applicants are no longer required to conduct mandatory analytical verification testing, including DNA testing, to demonstrate the absence of animal-derived materials in the final product.
Instead, applicants may submit alternative scientific justifications, including:
- Manufacturing process declarations;
- Explanations of purification and removal processes;
- Process validation data;
- Other relevant scientific evidence.
The suitability of such evidence will be assessed by NPRA reviewers on a case-by-case basis.
2. Primary Packaging Materials Excluded from Assessment
When evaluating and declaring animal-derived ingredients, the source of materials used in primary packaging components will no longer be included within the assessment scope.
This exemption aligns Malaysia’s regulatory approach with international practices adopted by organizations such as:
- World Health Organization (WHO);
- European Medicines Agency (EMA);
- U.S. Food and Drug Administration (FDA).
3. Mandatory Animal-Origin Label Declaration
A clear declaration of animal origin is now mandatory for any animal-derived ingredient present in the final product, including:
- Active ingredients;
- Excipients;
- Preservatives;
- Capsule shells (e.g., gelatin capsules);
- Other animal-derived materials.
The specific animal source must be clearly stated on the product label.
Supplementary Label Statements
Manufacturers may voluntarily include additional statements on the outer carton if DNA testing has been conducted and no animal DNA was detected in the final product.
For example:
“Porcine-derived ingredient used during manufacturing. No porcine DNA detected in the final product.”
However, NPRA emphasizes that a negative DNA test result does not exempt manufacturers from the mandatory animal-origin labeling requirement.
In other words, analytical testing cannot replace or waive the obligation to declare animal-derived ingredients on product labels.
Updates to the Drug Registration Guidance Document (DRGD)
NPRA has confirmed that the following sections of the Drug Registration Guidance Document (DRGD) will be revised accordingly:
Appendix 19 – General Labeling Requirements
Table 1, Item 17 will be updated to explicitly require declarations for all animal-derived ingredients, including:
- Active substances;
- Excipients;
- Gelatin and other animal-derived materials.
Appendix 4 – Biologics Registration Guidance
The revised guidance will require applicants to provide scientific evidence demonstrating the presence or absence of animal-derived materials in APIs and/or finished products.
Acceptable evidence may include:
- DNA PCR testing;
- Detailed descriptions of purification and manufacturing processes;
- Other scientifically justified documentation.
The guidance further reiterates that any animal-derived ingredient present in the final product must be clearly declared on the label regardless of analytical test results.
Effective Date and Transitional Arrangements
The revised requirements take effect immediately and apply to:
- New product registration applications;
- Applications currently under review.
The following previous circulars have been revoked with immediate effect:
- NPRA.600-1/9/12(20)
- NPRA.600-1/9/12(25)
In addition, a revised 2026 edition of the Appendix 19 Frequently Asked Questions (FAQ) document will be issued to replace the current version.
Regulatory Impact
The updated policy represents a significant shift in regulatory focus. Rather than requiring mandatory verification testing to demonstrate the absence of animal-derived materials, NPRA now adopts a more flexible, science-based approach that accepts multiple forms of supporting evidence.
At the same time, the agency strengthens transparency requirements by making clear animal-origin labeling mandatory for all products containing animal-derived ingredients, regardless of DNA test outcomes.
This change is expected to reduce unnecessary testing burdens while ensuring that healthcare professionals and consumers receive clear information regarding the origin of product ingredients.