- What is the purpose of implementation?
The primary purpose of the declaration requirement is to provide transparent information, enabling patients to make informed decisions about their treatment while upholding the sensitivity of public interest.
The revision to Clause 17 under Appendix 19 aims to provide flexibility for applicants who refuses to declare the animal origin statement on the product label, provided they can offer satisfactory confirmation, subject to NPRA's discretion. Please note that this is not a mandatory document or test; it only applies to those who decide not to declare the animal origin statement on the product label. This requirement has been in effect since 2007 and is not constitute a new or additional registration requirement.
Therefore, these amendments will not have any impact on the accessibility or availability of the product in market and should be regarded as a clarification of the existing country-specific requirements. Applicants are encouraged to include the declaration on the label if the necessary testing is not intended to be conducted.
- What types of products are involved?
The requirement for the declaration of animal-derived materials applies to both pharmaceutical and natural products and covers the entire final product, including the container closure system, also known as primary packaging. Primary packaging is defined as packaging that comes into direct contact with the drug product.
For biologic/biopharmaceutical products that commonly use animal-derived materials in their manufacturing processes, which differ from the manufacturing processes of pharmaceutical and natural products, the circular NPRA.600-1/9/12 (20) dated 24th May 2023; The Requirements of Deoxyribonucleic Acid (DNA) Testing for Biological Products That Use Animal-Derived Materials, applies.
- What is the scope of implementation?
The requirement for the declaration of animal-derived materials has been in place since 2007, as outlined in the Drug Registration Guidance Document under Appendix 19: General Labelling Requirements. This applies to all products undergoing evaluation, including new registrations and variations. Reassessment of currently registered product labels is not required unless a variation or other relevant issue necessitates label changes.
- Is there a grace period to comply with the requirements for registered products?
The policy has been in effect since 2007, as outlined in the Drug Registration Guidance Document under Appendix 19: General Labelling Requirements. The amendment (circular (NPRA.600-1/9/12(25)) aims to clarify Clause 17 under Appendix 19 by considering the need to submit satisfactory confirmation verifying the absence of animal materials if the applicant chooses not to include a declaration on the product label.
As this is an existing policy, no grace period is provided to comply with the requirements. If variation is required, a variation application under MiV-PA2 (Change of Drug Product Labelling in accordance with country-specific labelling requirements) need to be submitted.
- What kind of scientific evidence is accepted by NPRA should the applicant refuses to declare the animal-derived materials on product label?
During product dossier submission for registration, the applicant is required to provide information regarding the use of animal-derived materials throughout the manufacturing process of the product. If animal derived materials were used, a declaration on the product label is required unless scientific evidence verifying the absence of animal materials can be provided.
The scientific evidence can be product-specific and will be subject to further review of the justification and documentation provided by the applicant to the NPRA. For example, a DNA PCR test can be accepted as satisfactory confirmation verifying the absence of animal materials in the final product. Alternatively, justification or a declaration issued by the product manufacturer / owner regarding the manufacturing process or processing methods (e.g., purification, etc.) used to remove animal-derived materials from the product can be provided as scientific evidence.
However, please note that for pharmaceutical and natural products, the scientific evidence for animal-derived materials, particularly those from porcine and canine sources, is subject to the guidelines outlined in NPRA Circular NPRA.600-1/9/12 (20), dated 24th May 2023, titled The Requirements of Deoxyribonucleic Acid (DNA) Testing for Biological Products That Use Animal-Derived Materials. This circular should be read together with the accompanying FAQ for a comprehensive understanding of the requirements.
- Are there any exemptions granted?
Clause 17 of Appendix 19, General Labelling Requirements, does not apply to low-risk or commonly used materials intended for human consumption, such as lactose, milk derivatives, beeswax in ointment products and printing/colouring inks derived from insect sources. This list is not meant to be exhaustive and will be reviewed from time to time.
