Philippines Adopts Harmonized Post-Marketing Alert System

On April 22, 2013, The Philippines Food and Drug Administration (FDA) adopted a harmonized Post-Marketing Alert System (PMAS) for unsafe medical devices and other products within the scope of the FDA.

The PMAS was developed by the Association of Southeast Asian Nations (ASEAN) to share information on product safety among member countries. In the event that a safety concern arises in any ASEAN country, a PMAS coordinator from that country will notify the agency’s International Affairs Office ensuring the information is distributed to all other ASEAN countries.

The PMAS will exchange information on:

  • Products for which registration has been cancelled, suspended, or withdrawn based on safety issues
  • Products recalled from the market due to quality defects with serious public health implications
  • Products found to be adulterated and associated with serious public health implications
  • Significant label changes, involving safety, that are initiated by the regulators
  • New restrictions on usage
  • Exchange of “Dear Healthcare Professional” letters, Media releases related to drug safety, and Adverse Drug Reaction bulletin publications
  • Adverse Event Reporting of cosmetic products