The Thai Food and Drug Administration (Thai FDA — สำนักงานคณะกรรมการอาหารและยา) is Thailand's national regulator for human and veterinary medicines, biologicals, vaccines, medical devices, IVDs, cosmetics, hazardous substances, narcotics, psychotropic substances and processed food. Thai FDA operates under the Ministry of Public Health (MOPH) from Nonthaburi under a stack of vertical acts: the Drug Act B.E. 2510 (1967, as amended), Medical Device Act B.E. 2551 (2008, as amended), Cosmetic Act B.E. 2558 (2015), Food Act B.E. 2522 (1979) and Narcotics Code B.E. 2564 (2021). Not to be confused with Taiwan's TFDA.

Thailand is a PIC/S member since 2016 and reached WHO Maturity Level 3 for medicines regulation in 2020. Medicines follow the ASEAN Common Technical Dossier (ACTD) format for generics with ICH CTD accepted for innovator products; medical devices follow the ASEAN Medical Device Directive (AMDD) with a four-class (1/2/3/4) risk-classified pathway aligned to IMDRF principles. Thai FDA operates reliance pathways for reference-authority approvals (FDA US, EMA, MHRA, Health Canada, TGA, Swissmedic, PMDA).

GMP inspections of overseas manufacturers are risk-based; PIC/S GMP certificates support desk review, while biologicals, sterile products, vaccines and high-risk devices attract on-site inspection. Thai FDA also enforces the pharmaceutical serialisation and traceability programme and the Cosmetic Notification System. V5 Ultimate maps directly onto Thai FDA expectations — bound e-signatures, ALCOA+ batch records, deviation/CAPA workflow, and a per-country dossier pack — with the paired guide at /glossary/thailand-fda.

Industries that live with this

Pharmaceutical Medical Devices

How V5 handles it

Score your compliance gap — then download the validation pack.

A guided self-assessment walks you against the regulator clauses that apply to your industry. The validation pack — IQ/OQ/PQ scripts, traceability matrix, risk assessment, intended-use statement — generates from the same evidence so you can hand it to an auditor on day one.

Document control with hard kiosk-level training enforcement.

Versioned SOPs are only useful if operators are actually trained on the current version. V5 enforces it at the kiosk.

QMS — quality engineered into every action, not bolted on.

Because V5 owns the operator action, the QMS sees the data the second it’s captured — not at the end of the shift.