Philippines | FDA Releases Revised Guidelines on Product Recalls, including cosmetics and medical devices

The Food and Drug Administration (FDA) has released revised guidelines on product recalls, which aim to strengthen the agency's oversight of these procedures and protect public health. The new guidelines cover all types of health products, including drugs, cosmetics, and medical devices.

Key provisions of the new guidelines include:

(*) The establishment of a Product Recall Committee (PRC) to oversee all aspects of product recalls.
(*) The categorization of recalls into three types: MAH-Initiated, FDA-Ordered, and Mandatory Recalls.
(*) A requirement for MAHs to submit a detailed recall report to the FDA within 24 hours of initiating a recall.
(*) The need for MAHs to conduct recall communication and effectiveness checks.
(*) The establishment of a system for traceability of affected products.
(*) The requirement for MAHs to conduct mock recalls on an annual basis.

The new guidelines also address FDA-Ordered recalls, which are initiated by the FDA when a product is found to be unsafe, defective, ineffective, or grossly deceptive. In such cases, the FDA may issue a recall order to the MAH or seize, quarantine, destroy, and/or dispose of the product at the MAH's expense.

MORE INFO ON fda.gov.ph