Obtaining marketing authorization is a fundamental requirement for bringing pharmaceutical products to the Thai market. Companies must navigate the Thai Food and Drug Administration’s registration procedures while also complying with post-approval pharmacovigilance obligations, licensing requirements for manufacturing and importation, data protection rules, and other regulatory requirements. This guide provides an overview of Thailand’s regulatory framework for pharmaceutical marketing authorization, including available registration pathways, review timelines, application fees, postmarketing surveillance obligations, licensing requirements, exemptions, data exclusivity, freedom of information, and parallel import considerations. It is intended as a practical reference for pharmaceutical companies, regulatory affairs professionals, and others involved in bringing medicinal products to the Thai market. Download the guide below for a concise overview of the current requirements and procedures governing pharmaceutical marketing authorization in Thailand.

Patent enablement requirements are provided under Article 102 of Vietnam’s Law on Intellectual Property (IP Law). In particular, a patent specification must “fully and clearly disclose the nature of the invention to such an extent that, based on the specification, a person having ordinary skill in the relevant art can implement the invention.” In pharmaceutical and biotechnology patents, this requirement is more complicated and subject to more rigorous assessment. The Patent Examination Guidelines (Guidelines) of the Intellectual Property Office of Vietnam (IP Office) were amended in March 2026 to introduce Annexes III and IV for the pharmaceutical and biotechnology sectors, in which Annex III provides detailed guidelines on the assessment of specification requirements. These amendments were made under a project for strengthening capacity in industrial property examination between the Japan International Cooperation Agency (JICA) and the IP Office. Annex III provides detailed instructions on how examiners assess enablement in a pharmaceutical or biotechnology application, and offers examples of acceptable and unacceptable descriptions with regard to the enablement aspect. Enablement Requirements in Pharma and Biotech Patents Article 12.7 of Circular 10/2026/TT-BKHCN (Circular 10) adds to the requirements of Article 102 of the IP Law that the description must demonstrate the novelty, inventive step, and industrial applicability of the technical solution. For pharmaceutical composition subject matters, Article 12.9 of Circular 10 sets out that the description must present the results of clinical trials and/or the pharmacological effects of the claimed pharmaceutical composition, and must include at least the following information: Substance/mixture used. Testing method (system) employed. Information on the test results. Correlation between the pharmacological effects obtained from the tests and the application of the pharmaceutical product in the prevention, diagnosis, and treatment of diseases. The Guidelines note that pharmacological study results should be presented in a quantified manner, and pharmacological

For the first time, Thailand’s Food and Drug Administration (FDA) has published a consolidated list identifying all substances that have successfully passed its novel food safety evaluation process. The list is a step forward in regulatory transparency, but it also highlights a feature of the Thai regime that food companies often overlook: each approval is tied exclusively to the company that applied for it. A substance’s appearance on the list does not give other companies the green light to use it. This article examines the structure of Thailand’s novel food approval framework, the implications of applicant exclusivity, and the strategic choices it requires of food companies looking to bring novel ingredients to the Thai market. Thai FDA Food Safety Evaluation Framework Notification No. 376 of the Ministry of Public Health requires novel food substances to undergo a food safety assessment, with an exemption only for novel foods manufactured exclusively for export. The framework also encompasses “foods that do not qualify as novel foods” but which present characteristics warranting a safety evaluation, such as differing quality standards, increased serving sizes, or applications in specific food categories, where such changes affect consumption levels, nutritional value, or consumer safety. The recently published list of foods that passed the safety evaluation by the Thai FDA is structured by substance category and identifies the approved company (domestic manufacturer or importer), country of origin, substance name and trade name, approved purpose of use, and date of the Thai FDA’s approval notification certificate. A notable feature of Thailand’s novel food regime is that the approval result is tied exclusively to the company that submitted the application. Publication of the consolidated list does not constitute a general authorization to use the approved substances. The Thai FDA’s approval certificate specifies the approved conditions of use and the requirements

Thailand’s new labeling requirements for medical devices, which include for the first time a unique device identification (UDI) requirement for software as a medical device (SaMD), take effect on June 20, 2026. The Notification of the Ministry of Public Health regarding Criteria, Methods, and Conditions on Labeling and Instructions for Use for Medical Devices 2025, which replaces a similar notification from 2020, was published in the Government Gazette on December 22, 2025. To ensure clarity, modernity, and patient safety, the regulation requires domestic manufacturers and importers to provide labels and instructions for use (IFU) that are clearly legible, complete, and free of false or misleading claims. It also permits IFU to be provided in electronic format, such as via QR codes, websites, or other digital channels—directly relevant to SaMD, where physical labels are impractical and electronic presentation is the natural medium. The notification distinguishes two categories for labeling language. Home-use medical devices (for lay users outside healthcare facilities) must have labels and IFU in Thai. Professional-use medical devices may display labels and documentation in either Thai or English. This distinction is significant for SaMD developers: software intended for clinical professionals may use English-language interfaces and IFU, while consumer-facing health applications must provide Thai-language content. Labeling and UDI Requirements Labels and IFU must include, at a minimum: Product name and intended purpose Quantity or volume Name and address of domestic manufacturer or importer Thai FDA approval number Lot, version, or serial number Manufacturing date and expiry date For SaMD, the version number requirement is particularly relevant. The regulation also mandates display of a UDI code for SaMD in risk category 2 (moderate-risk), category 3 (moderate- to high-risk), and category 4 (high-risk), according to Thailand’s medical device risk classification system (which complies with the ASEAN Medical Device Directive and the EU