Philippines

Pharmacovigilance in the Philippines is regulated by the Food and Drug Administration (FDA) under FDA Circular No. 2020-003 and related post-marketing requirements. MAHs must establish a pharmacovigilance system and designate qualified PV personnel, collect and submit reportable adverse reactions within the circular's timelines, maintain records, communicate significant safety issues and fulfil applicable PBRER/PSUR, RMP and post-marketing commitments. An EU-style PSMF is not a universal Philippine requirement and applies only where the Philippine procedure or FDA specifically requires it. Where the cited public sources do not expressly define local QPPV or responsible-person arrangement, signal management and audit and inspection arrangements, the MAH should confirm the current product-specific requirements with the competent authority and against the marketing-authorisation conditions. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.