Philippines: FDA Overhaul for 2013

The Food and Administration of the Philippines (PFDA) is undergoing radical restructuring to improve its services starting in 2013. As a result, the PFDA stopped receiving applications for the procedures listed below on December 1, 2012, and it is expected to resume normal operations on February 1, 2013.

Currently Suspended Applications:

  • Licensing: GMP and HACCP Certification, Import Permit for Manufacturers
  • Product Registration: Certificates of Free Sale, Pharmaceutical Product, Exemption from Product Registration, and Generic Labeling Exemption
  • Clinical Review: New Chemical Entity, New Dosage Strength and Form, New Formulation, New Indication, Protocol and Amendment for Clinical Study (Phase I, II, and III), Classification/Reclassification of Product, Approval for Product/Label Claim
  • Certified True Copies
  • And others

Currently Accepted Applications:

  • LTO and CPR renewal and verification
  • Export certificates for drugs and cosmetic products
  • Import Permit for Investigational Drug Products
  • Follow-up on new applications
  • And others

More detailed information can be found on the PFDA website at