Thailand
Food and Drug Administration, Thailand (Thai FDA) (Thai FDA)
Thailand regulates pharmaceutical products through the Food and Drug Administration (Thai FDA), an agency under the Ministry of Public Health (MoPH). The legal framework rests on the Drug Act B.E. 2510 (1967, as amended, including the 2019 amendment) and subordinate Ministerial Regulations. The Drug Control Division within Thai FDA administers product registration, GMP/GDP licensing, pharmacovigilance, and post-market surveillance, with statutory decisions made by the Drug Committee. Thailand is an ASEAN member that has implemented the ASEAN Common Technical Dossier (ACTD) and ACTR. Reliance on Stringent Regulatory Authorities (US FDA, EMA, MHRA, Health Canada, TGA, PMDA, Swissmedic) and WHO Prequalification underpins abridged review for new drugs. Reimbursement runs through three public schemes — Universal Coverage Scheme (UCS, NHSO), Social Security Scheme (SSS) and Civil Servant Medical Benefit Scheme (CSMBS) — with the National List of Essential Medicines (NLEM) administered by the Subcommittee on the Development of the NLEM serving as the gatekeeper for public-sector reimbursement. The Health Intervention and Technology Assessment Program (HITAP) provides HTA support.
About the authority
Thai FDA is the national competent authority for therapeutic goods under the Ministry of Public Health. The Drug Control Division administers product registration, GMP/GDP licensing, controlled substances, pharmacovigilance and post-market surveillance. Statutory registration decisions are made by the Drug Committee on the recommendation of expert sub-committees. Thai FDA has been a PIC/S member since 2016 and an ICH Observer.
Reliance & recognition
Thai FDA recognises SRA approvals and WHO Prequalification as the basis for abridged / reliance review. ASEAN harmonisation (ACTD/ACTR) supports cross-recognition of dossier format and BE studies within ASEAN; a complete dossier and Thai-language administrative documentation are still required.
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