Philippines

The Philippines regulates pharmaceutical products through the Food and Drug Administration (FDA Philippines), an agency under the Department of Health (DOH) established by Republic Act No. 9711 (FDA Act of 2009). Within FDA, the Center for Drug Regulation and Research (CDRR) administers product registration, GMP licensing, pharmacovigilance and post-market surveillance. Marketing authorisation is evidenced by a Certificate of Product Registration (CPR), valid for 5 years. FDA Philippines operates Standard, Abridged and Verification review pathways under Administrative Order No. 2020-0045 and FDA Circular No. 2022-004, with reliance on Stringent Regulatory Authorities (SRAs) — US FDA, EMA, Health Canada, TGA, PMDA, MHRA, Swissmedic — and WHO Prequalification underpinning the abridged / verification routes. The Philippines is an ASEAN member implementing the ASEAN Common Technical Dossier (ACTD) and ACTR. Public-sector access runs through PhilHealth (Philippine Health Insurance Corporation) under the Universal Health Care Act (RA 11223, 2019), with the Philippine National Formulary (PNF) — administered by the DOH National Formulary Committee — as the gatekeeper for public-sector use and PhilHealth packages. The Health Technology Assessment Council (HTAC), established under the UHC Act, provides HTA recommendations.