On March 31, 2025, the Food and Drug Administration (FDA) of the Philippines released a draft circular titled “Guidelines on the Recall of Authorized Health Products Regulated by the Food and Drug Administration”.
The draft circular aims to establish effective recall procedures for authorized health products regulated by the FDA in the Philippine market. The FDA is requesting feedback from stakeholders and Market Authorization Holders (MAHs) to support the development of clear and practical guidelines.
Comments and suggestions must be submitted on or before May 2, 2025.
The full draft circular is available here:
https://www.fda.gov.ph/draft-for-comments-guidelines-on-the-recall-of-authorized-health-products-regulated-by-the-food-and-drug-administration/ (PDF Available)
Implications to Clients
As this circular is currently in draft form, there are no immediate regulatory implications for MAHs or stakeholders. However, this is an opportunity to provide input before the final implementation. Comments, suggestions, and clarifications may be submitted to the FDA ahead of the May 2, 2025, deadline.
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