The FDA of the Philippines has established registration pathways for the registration and evaluation of drug products, including vaccines and biologicals. This is in line with the principals of international regulatory cooperation, while ensuring the requirement for timely access to medicines and streamlining government transactions
The Administrative Order 2020-0045 aims to:
1. Define the routes for facilitated registration;
2. Determining the eligibility criteria for the drug products and applicants; and,
3. Define the arrangements to execute these mechanisms.
This Order aims to establish facilitated registration and evaluation pathways for
drugs, including vaccines and biologicals, through three routes:-
1. Abridged review- Incorporates a submission for the suitability of the dossier in location conditions and regulatory requirements while depending on initial assessment from a reference drug regulatory agency or agencies to convey the local decision. It also incorporates a limited review of the specific part of the dossier.
2. Verification review- Two reference drug regulatory agencies will review and approve the submission whereby the FDA FDA only validates the submission and ensures that the product complies with standards, requirements, and registration conditions,
3. Collaborative procedure. An assessment process through joint review, reliance, work-sharing by FDA with World Health Organization Prequalification of Medicines Programme (WHO-PQP), or other drug regulatory agencies
For more information:-
Link: https://www.fda.gov.ph/wp-content/uploads/2020/10/Administrative-Order-2020-0045.pdf