Thailand’s approach to cannabis regulation has moved quickly from broad access to a medical, prescription‑only system. The latest government regulation classifies the cannabis flower as a controlled herb under the Thai Traditional Medicine Wisdom Act. The latest rules ban advertising and recreational sales, allow sales only to patients with prescriptions (up to 30 days), and require flowers to come from GACP‑certified (Good Agricultural and Collection Practices) farms. More importantly, cannabis dispensaries can only sell to patients presenting valid prescriptions issued by one of seven professions—medical doctors, Thai traditional practitioners, applied Thai traditional practitioners, traditional Chinese medicine practitioners, pharmacists, dentists, and folk healers—consistent with approved clinical indications. Noncompliance risks license suspension or revocation, and criminal penalties of up to one year’s imprisonment or a THB 20,000 fine. The dispensary‑only model that proliferated in Thailand in recent years is expected to end soon, as the rules will push all cannabis dispensaries into medical settings or retail pharmacies. Dispensaries must convert into medical establishments—clinics, pharmacies, or traditional pharmacies—complete with on‑site licensed practitioners as well as budtenders; strong controls for storage, hygiene, odor, and smoke; and facilities for record-keeping. All flowers dispensed or exported must come from GACP‑certified farms. If the government ends dispensaries outright and forces a conversion to clinics or pharmacies, compensation will not be automatic at the outset. As a result, business operators should plan for compliance and repurposing under the Medical Facilities Act, Modern Drug Act, and Herbal Product Act, which regulate medical clinics, modern pharmacies, and traditional medicine pharmacies, respectively. The table below summarizes the required licenses for clinics, pharmacies, and traditional medicine pharmacies selling cannabis flowers in Thailand. Aside from the specific listed licenses, all three types of establishments must also obtain a license to sell a controlled herb (cannabis flowers) from the Department of Thai Traditional

On December 30, 2025, Thailand’s Electronic Transactions Development Agency (ETDA) notified digital marketplace operators of a consolidated list of “high‑risk products” that are subject to strict monitoring on digital platforms. The list was jointly prepared by the Thai Industrial Standards Institute (TISI) and the Food and Drug Administration (FDA) to guide platform compliance in the initial phase of implementation of the Electronic Transaction Committee’s Notification on Other Measures for Marketplace for Goods with Specific Characteristics under Section 18(2) of the 2022 Royal Decree on Digital Platform Businesses Requiring Notification B.E.2568 (2025). The notice is addressed to operators of digital platform services that function as product marketplaces with specific characteristics laid out in the notification. The ETDA states that the TISI and the FDA are closely monitoring the high‑risk product categories on digital platforms, and the published list serves as the baseline reference for platform screening during the initial phase of the notification’s implementation. High‑Risk Product List The list aggregates categories of products that are illegal to sell online or are otherwise tightly regulated under Thai law, with an emphasis on health-related products, controlled substances, medical devices, and a wide range of industrial products that require certification or compliance with specified Thai Industrial Standards, as detailed below. Prohibited and tightly controlled health products. This includes all categories of modern medicines subject to control other than general household remedies; all categories of controlled herbal products except for over-the-counter herbal products; narcotics; psychotropic substances; and medical devices requiring use in medical facilities or a physician’s prescription. Selected industrial products requiring heightened controls. The list highlights dozens of TISI-regulated items commonly sold online. Examples include pacifiers, rice cookers, electrical wire, food wrap film, crayons, washing machines and dryers, air conditioners, electric cookers and air fryers, water heaters, microwave ovens, LED luminaires, hair dryers

On December 31, 2025, Vietnam’s Ministry of Health (MOH) issued Circular No. 57/2025/TT-BYT providing guidance on the classification of medical devices according to technical standards and quality requirements (Circular 57), applicable to procurement activities for medical devices in Vietnam. According to the MOH, the purpose of the classification is to establish a principle-based legal framework and regulations that enable purchasers to easily identify groups of medical devices aligned with their professional requirements and financial capacity. Some of the key stipulations of Circular 57 are outlined below. Basis for Determining Technical Standards and Quality Under Circular 57, the technical standards of medical devices are determined in accordance with Vietnamese laws on standards and technical regulations, through the following means: Certification of conformity with standards in accordance with Vietnamese laws on standards and technical regulations; Results of conformity assessment conducted by an internationally recognized conformity assessment organization or a legally established domestic or foreign conformity assessment organization operating in Vietnam; and Documentation evidencing compliance provided by the medical device owner. The quality of medical devices is determined based on whether the device has been approved for circulation by the relevant marketing authority of one or more jurisdictions. Classification of Medical Devices Circular 57 classifies medical devices into six groups (from Group 1 to Group 6) based on technical standards and quality. Medical devices subject to classification must simultaneously meet technical standards and quality requirements in accordance with professional specifications and user needs, and must be lawfully marketed in Vietnam. Medical devices manufactured in Vietnam may participate in all corresponding groups, provided they meet the technical standards required by the user and are lawfully marketed in Vietnam. Outlook Circular No. 57 will take effect on February 15, 2026, while the classification requirements will become effective on January 1, 2027. Holders of medical

The Intellectual Property Office of Vietnam (IP Office), with support from the Japan International Cooperation Agency (JICA), is drafting additional annexes to its Guidelines for Patent Examination, focusing on the examination of patent applications in the pharmaceutical and biotechnology sectors. The new annexes are expected to be officially issued in early 2026 as Annexes III and IV, following the successful issuance in 2023 of Annexes I and II addressing computer program-related inventions. The IP Office recently organized a seminar to gather feedback on the draft annexes from intellectual property representatives, academic institutions, research institutes, and other interested parties, emphasizing its intention to receive further constructive opinions to refine the guidelines for pharmaceuticals and biotechnology. Why These Guidelines Matter Patent examination in Vietnam has traditionally relied on the Guidelines for Patent Examination issued under Decision No. 487/QD-SHTT (2010), recently supplemented by Annexes I and II. While these documents provide a solid foundation, they do not fully address practical challenges in examining pharmaceutical and biotech inventions, particularly issues related to clarity, sufficiency of disclosure, enablement, features of function and utility, combination therapies, and inventions involving artificial intelligence (AI) applications in these fields. Annexes III and IV aim to close these gaps by introducing structured principles and illustrative examples. Guidance on Patent Specification Requirements Annex III provides detailed guidance on the requirements for patent specifications in pharmaceuticals and biotechnology, covering two main parts: Part A addresses sufficiency of disclosure, clarity of specifications, and consistency between claims and descriptions. Part B covers inventions related to Markush-type compounds, claims containing exclusion statements (disclaimers), and additional experimental data submitted during examination. The Guidelines outline specific disclosure requirements for subject matters such as compounds, formulations, pharmaceutical compositions, genes, polypeptides, proteins, vectors, transgenic organisms, modified organisms, and hybrid cells. Annex III emphasizes that disclaimers are not accepted