The Drug Control Authority (DCA) updated the Drug Registration Guidance Document (DRGD) on the requirements of DNA testing for final biologic products containing materials of animal origin in the manufacturing process on 11 May 2023. This requirement is effective immediately from the date of this notice for new applications and applications under evaluation of biologic products.
The updated guideline in Appendix 4 which has been agreed upon includes the requirement to provide a confirmation on the presence/ absence of the animal materials in the final product through DNA testing by PRC or any qualified and validated analytical method. If the analytical results are positive or the DNA test on the final product is not submitted, labels should contain the information about the animal’s origin (specifying the name of the animal(s)) accordingly. This update will be updated in the Third Edition of DRGD (5th Revision, July 2023).
However, DNA testing is not required for biologic products in which animal-derived materials are being used as excipients, capsules or preservatives in the finished product.
For approved biological products, the Product Registration Holder (PRH) is advised to apply for variation application voluntarily by submitting the analytical result of DNA testing for the final product containing animal-derived material.
Additionally, documentation of DNA testing analytical results or declaration on the product label is to be made available upon request by the NPRA.
Source: NPRA
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