The Food and Drug Administration (FDA) Philippines released FDA Advisory No. 2025-0496 on 10 April 2025, titled “Allowing the Submission of Multiple Post-Approval Changes (PACs) of a Registered Pharmaceutical Product in a Single Application”. This initiative is part of the agency’s commitment to enhancing regulatory efficiency and supporting the pharmaceutical industry’s compliance efforts.
Under this advisory, Marketing Authorization Holders (MAHs) are now allowed to consolidate multiple PACs for the same registered product into one application. This streamlining measure aims to reduce the administrative burden on both the applicant and the FDA, minimize processing timelines, and promote faster access to quality-assured medicines in the market.
This applies only to Major Variations (MaV) and Minor Variation Prior Approval (MiV-Pa) applications.
It is important to note that specific conditions and requirements must be met for the consolidated submission to be accepted. MAHs are strongly encouraged to review the full advisory for detailed guidance.
For more information and submission guidelines, you may access the full advisory through the official FDA Philippines website: