Thailand

Thailand's primary regulatory authority for health products is the Food and Drug Administration (FDA) operating under the Ministry of Public Health (MOPH). The Thai FDA oversees the registration and market approval of pharmaceuticals, medical devices, diagnostics, and digital health solutions under a suite of governing legislation, including the Drug Act B.E. 2510 (1967) and its amendments, the Medical Device Act B.E. 2562 (2019), and associated ministerial regulations. The approval process typically involves dossier submission, technical review, and in some cases local conformity assessments or inspections before a license or registration certificate is granted. Products are classified by risk level, with higher-risk categories subject to more rigorous pre-market review pathways.

Applicants must appoint a locally registered entity as the official importer or licensee, as foreign manufacturers cannot apply directly without a Thai-registered representative or agent. Pharmaceutical dossiers are generally submitted in the ASEAN Common Technical Dossier (ACTD) format, although alignment with the ICH Common Technical Document (CTD) is increasingly accepted, reflecting Thailand's engagement with regional ASEAN harmonization initiatives. Medical devices follow the ASEAN Medical Device Directive (AMDD) framework for classification and submission requirements. Notable recent reforms include the full implementation of the Medical Device Act B.E. 2562, which introduced a risk-based classification system and strengthened post-market surveillance obligations. Thailand has also expanded its use of regulatory reliance pathways, allowing abbreviated reviews for products already approved by recognized stringent regulatory authorities such as the US FDA, EMA, or Japan PMDA, which can significantly reduce review timelines for qualifying submissions.

Public procurement of health products in Thailand is primarily coordinated through the Ministry of Public Health and its subordinate departments, including the Department of Medical Sciences and the Government Pharmaceutical Organization (GPO). The National Health Security Office (NHSO) plays a central role in determining product listings and reimbursement under the Universal Coverage Scheme (UCS), one of three main public health financing schemes alongside the Civil Servant Medical Benefit Scheme (CSMBS) and the Social Security Scheme (SSS). Public hospital procurement follows the Government Procurement and Supplies Management Act B.E. 2560 (2017), which governs competitive tendering processes at both the central and facility levels. The National Drug Committee oversees the National List of Essential Medicines (NLEM), and inclusion on this list is typically a prerequisite for public reimbursement and large-scale public procurement.

The private healthcare sector in Thailand is substantial and commercially significant, encompassing a large network of private hospitals and clinic chains, particularly in Bangkok and major urban centers. Private procurement operates independently of government tender systems, with purchasing decisions made at the hospital or group level, often influenced by clinical preference and distributor relationships. Thailand has limited reliance on donor-funded procurement channels such as UNICEF Supply Division, the Global Fund, or USAID compared to lower-income markets in the region, given its upper-middle-income status and largely self-funded public health system. However, donor-supported initiatives occasionally operate in specific disease areas such as HIV and tuberculosis. The Thai government actively promotes local manufacturing capacity, and the GPO serves as a state-owned manufacturer with preferential positioning in public tenders. Policies encouraging domestic production, including price preferences and strategic partnerships for technology transfer, are periodically reinforced through MOPH directives and national health security strategies.