Thailand

The Thai Food and Drug Administration (Thai FDA), operating under the Ministry of Public Health (MoPH), serves as the primary regulatory authority responsible for the approval, licensing, and post-market surveillance of health products in Thailand, including pharmaceuticals, medical devices, diagnostics, and digital health solutions. The overarching legal framework is established through a series of product-specific acts, notably the Drug Act B.E. 2510 (1967) and its amendments, the Medical Devices Act B.E. 2562 (2019), and relevant ministerial regulations governing biologics and diagnostics. All health products intended for sale or use in Thailand must obtain a Thai FDA license or notification prior to market entry, with the review process varying in complexity based on product classification, risk category, and whether the product has received prior approval from a recognized regulatory authority such as the US FDA, EMA, or members of the International Medical Device Regulators Forum (IMDRF).

Key submission requirements mandate that foreign manufacturers appoint a locally registered Thai importer or authorized representative who holds legal responsibility for the product on the Thai market. Dossiers are generally expected to conform to ASEAN Common Technical Dossier (ACTD) standards for pharmaceuticals, with alignment to ICH Common Technical Document (CTD) format also accepted, particularly for products already approved in ICH member countries. Thailand is an active participant in the ASEAN harmonization framework and applies ASEAN Medical Device Directive (AMDD) principles for device classification and registration. Notable recent reforms include the full implementation of the Medical Devices Act B.E. 2562, which introduced a modern risk-based classification system (Class 1 through Class 4) replacing the previous outdated framework, a digital e-submission portal to streamline applications, and expedited review pathways for innovative or priority products. Thailand has also expanded its use of reliance procedures, allowing the Thai FDA to reference decisions made by trusted foreign regulatory authorities to accelerate approvals.

Public sector procurement in Thailand is highly centralized and is governed primarily by the Government Procurement and Supplies Management Act B.E. 2560 (2017), administered through the Comptroller General's Department under the Ministry of Finance. The Ministry of Public Health, through its Medical Supply Center and the Government Pharmaceutical Organization (GPO), coordinates the bulk of health product procurement for public hospitals and health facilities across the country. The GPO, a state enterprise, plays a dominant role not only as a local manufacturer of essential medicines and medical supplies but also as a central procuring entity for products distributed through the national health system. Thailand operates a tiered public health system encompassing central, regional, provincial, and district hospitals, with procurement authority partially delegated to individual hospital pharmacies for certain product categories, though major tenders and national essential medicines list (NEML) items are typically managed centrally through the MoPH and the National Health Security Office (NHSO), which administers the Universal Health Coverage (UHC) scheme covering the majority of the Thai population.

The private healthcare sector in Thailand is substantial and represents a significant parallel market, particularly in urban centers such as Bangkok where large private hospital groups procure health products independently through direct commercial channels without being subject to public tender requirements. Pricing and reimbursement in the private sector are largely market-driven, though the National List of Essential Medicines (NLEM) and reference pricing policies influence overall market dynamics. Donor-funded procurement channels, including those managed by UNICEF, the Global Fund to Fight AIDS, Tuberculosis and Malaria, USAID, and Gavi, the Vaccine Alliance, play a more limited role in Thailand compared to lower-income regional neighbors, given Thailand's upper-middle-income status; however, certain disease-specific programs and vertical health initiatives may still involve international procurement mechanisms. Thailand maintains explicit policies favoring locally manufactured products, with the GPO's domestic production capacity given preferential consideration in public tenders, and compulsory licensing has historically been exercised for certain high-cost essential medicines to enable local generic production and reduce procurement costs within the public health system.