Philippines FDA Issues Draft Circular to Improve the Recall System for Health Products

The Food and Drug Administration (FDA) of the Philippines has released a draft circular suggesting new guidelines for the recall of health products that have been authorized for sale and present a significant risk to public health. The new circular is intended to revise FDA Circular No. 2016-012 to take into account considerable changes in the FDA’s regulatory process and the increase in healthcare product categories. These proposed guidelines aim to enhance post-marketing surveillance (PMS) of health products to clarify the role and responsibility of Marketing Authorization Holders (MAHs) when initiating product recalls and engaging in effective communication and traceability of health products during recalls.

The FDA indicates that MAHs must have recall systems in place as part of their risk management plans and must notify the FDA within 24 hours if it has become aware of a defect in a health product. The draft circular proposes recalls to be classified and organized by their specific risk to the public’s health, a requirement of MAHs to communicate with the FDA, and guidance on how to evaluate effectiveness following the recall. The new system establishes an FDA Product Recall Committee (PRC) that will be responsible for organizing recalls and supporting domestic and foreign stakeholders in the process. The draft circular also indicates that action could be taken against MAHs who do not comply with a recall – including suspension or revocation of authorization for that product, loss of MAH license, etc. The FDA is inviting public comments about the draft circular to finalize a revised recall system that is consistent with an international standard to better protect healthcare consumers.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)