Regulatory Affairs Update: Philippines

Philippines: PFDA Released Draft Guidelines On The Recall Of Health Products

As part of the larger Post Market Surveillance (PMS) activity in the Philippines, the Food and Drug Administration (FDA) issued a draft on the Guideline for The Recall of Health Products. The main goal of the issuance of this draft guideline is to update the previously issued FDA Circular No. 2016-012. This draft guideline will be applicable to all licensed manufacturers, traders, distributors (importers, exporters, wholesalers) of health products, drug outlets, and retailers of medical devices.

The issued draft guideline covers the following aspects:

  1. Types of recall (voluntary and mandatory Recall).
  2. Contents of the recall report (product identification, recall reason, recall strategy, product distribution details).
  3. Reporting timing and submission of report notification.
  4. Classification of recall.
  5. Recall communication scheme.
  6. Recall effectiveness, completion, and termination.
  7. Recall readiness.
  8. Penalty due to violation of the guideline.

Further information on the draft guideline can be accessed here.

If you have any queries about this draft guidance, please contact us at or click the button below.

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