Thailand

Pharmacovigilance in Thailand is regulated by the Thai FDA and Health Product Vigilance Center (HPVC). The current national framework includes the Thai post-marketing safety-reporting guidance for licence holders updated on 6 May 2026. MAHs must collect and submit ICSRs and significant safety information according to the applicable reporting rules; PBRER/PSUR and RMP submissions are generally authority- or product-driven, while new drugs, new generics and new biological products may be monitored through risk-based safety programmes. The framework does not automatically require an EU-style QPPV or PSMF for every MAH. Where the cited public sources do not expressly define 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.