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 study systems include clinical studies, animal experiments, and in

On May 26, 2026, Thailand’s Department of Land Transport (DLT) published for public consultation a draft amendment to the Ministerial Regulation on Electronic Ride-Hailing Vehicles that would, for the first time, allow juristic persons (legal entities) to register vehicles as electronic ride-hailing cars—a right that currently belongs exclusively to natural persons, limited to one person per one vehicle. If finalized in its current form, the regulation would significantly expand the supply side of Thailand’s ride-hailing market by enabling corporate fleet operators to enter the space. The public comment period is open through June 24, 2026. Key Principles Under the Draft Regulation Under the proposed amendment, juristic persons that maintain a fleet of at least 50 vehicles will be permitted to register vehicles as electronic ride-hailing cars. This represents a fundamental shift from the current framework, which restricts registration to individual natural persons on a one-person-one-car basis. Vehicle Specifications Corporate-owned ride-hailing vehicles must meet the following requirements: Be brand new from the factory, or no more than two years old from first registration with no more than 20,000 km of use. Not be a vehicle that has been reconstructed or repaired after involvement in a serious accident affecting safety—a standard consistent with public transport vehicles (RorYor. 6). Be classified as small, medium, or large in accordance with ministerial or director-general specifications. The vehicles may be equipped with safety devices such as interior or exterior cameras (video/photo recording) and can retain the original factory color of the vehicle body (no mandatory color change is required). License Plates Corporate ride-hailing vehicles will use license plates of the same size, characteristics, and color as those for private passenger vehicles not exceeding seven seats (RorYor. 1), rather than public transport plates. Potential Impact The government has stated that the regulation is intended to: Promote employment opportunities for ride-hailing drivers who can rent vehicles from corporate fleet operators

Thailand’s Board of Investment (BOI) has significantly revised its post-approval compliance framework for projects that receive investment promotion incentives, replacing the previous semiannual reporting system for project progress with a new quarterly reporting regime. The initial report is due by July 30, 2026, covering the second-quarter reporting period of April to June 2026. The new requirements—implemented through BOI Announcement No. 8/2569 and Office of the BOI Notification No. Por. 8/2569, both of which became effective on March 30, 2026—apply both to newly promoted projects and to existing promoted projects that remain in the implementation stage. Background Under the previous reporting framework, BOI-promoted companies that had not yet commenced full operations were generally required to submit reports on project progress to the BOI twice a year (February and July) through the BOI’s e-Monitoring system. By adopting a quarterly reporting regime, the BOI seeks to strengthen monitoring and evaluation of investment progress and project implementation. Reporting Requirements Under the new regulations, BOI-promoted companies must submit project progress reports on a quarterly basis during the implementation phase of a promoted project. The reporting periods and submission deadlines are: Q1 (January–March): April 30 Q2 (April–June): July 30 Q3 (July–September): October 30 Q4 (October–December): January 30 of the following year The quarterly reporting obligation runs from the date the BOI promotion certificate is issued until the BOI grants approval for commencement of full operations. For newly promoted projects, no quarterly report is required for the quarter in which the BOI promotion certificate is issued—the first reporting obligation arises in the immediately following reporting period. All project progress reports must be submitted electronically through the BOI’s e-Monitoring system. The existing annual reporting requirement also remains in effect, requiring promoted companies to submit an annual operating results report through the e-Monitoring system by July 31 of each year, regardless of whether the promoted project has fully commenced operations. Existing

On May 14, 2026, Thailand published a ministerial regulation in the Government Gazette to prescribe measures for prevention and suppression of technology crimes. The regulation creates a comprehensive procedural framework for returning money and digital assets to victims of technology crimes. It will take effect 90 days after publication (in mid-August 2026), giving affected entities a limited window to prepare. Mandatory Reporting Obligations for Financial Institutions When a deposit account, e-money account, or digital asset wallet is frozen in connection with a technology crime, the relevant financial institution or business operator must report transaction data to the Anti-Money Laundering Office (AMLO) via AMLO’s designated electronic system. Required data elements include account numbers (sender and receiver), names, identification or passport numbers, legal entity registration numbers, phone numbers, remaining balance, damage amount, transaction reference numbers, and the bank case ID. Institutions that already share data through the information-sharing system under the emergency decree are deemed to have satisfied this reporting obligation, creating an incentive for platform participation. When the Royal Thai Police or the Department of Special Investigation seize or freeze assets related to technology crimes, they must provide AMLO with investigation reports, complaint evidence, money-trail data, and account statements. Notification and Claims Process Once the AMLO secretary-general approves verified reports of a technology crime, the account information of persons connected to the crime will be published in the Government Gazette, triggering a 90-day window for victims to file claims and for related persons to file objections. Officers will also publish details on AMLO’s electronic media and send registered mail to identified victims, which will be deemed received after 7 days domestically or 15 days internationally. Victims have 90 days from the date the crime is published in the Government Gazette to file claims through AMLO’s electronic system. Claims must include the victim’s information, damage amount, refund channel, and

Arbitrator independence and impartiality form the cornerstone of a legitimate arbitral process. Under section 19 of the Thai Arbitration Act B.E. 2545 (2002), prospective arbitrators must disclose circumstances likely to give rise to justifiable doubts as to their impartiality or independence, and existing arbitrators must do so throughout proceedings. This mirrors article 12 of the UNCITRAL Model Law. Yet despite this clear mandate, practical implementation varies significantly across Thailand’s arbitration landscape. Background Thailand’s two principal arbitration institutions, the Thai Arbitration Institute (TAI) and the Thailand Arbitration Center (THAC), both maintain procedures for addressing arbitrator challenges and require compliance with the statutory disclosure obligation. Under both sets of rules, any party wishing to challenge an arbitrator must submit a challenge application within fifteen days of becoming aware of the relevant facts, and a committee is appointed to consider the matter on a case-by-case basis. The TAI additionally prescribes its Code of Ethics and Conduct for Arbitrators to further emphasize the expectation of impartiality and transparency. However, Thailand’s arbitration ecosystem extends well beyond the TAI and THAC. Several sector-specific institutions also administer arbitral proceedings, including the Thai Commercial Arbitration Office under the Board of Trade of Thailand, the Arbitration Centre of the Office of the Insurance Commission, the Arbitration Centre of the Securities and Exchange Commission, the Office for the Prevention and Resolution of Disputes regarding Intellectual Property, and the Arbitration Centre of the Thai General Insurance Association. These institutions each operate under their own procedural rules, which were developed to serve particular industries and dispute profiles. The procedural mechanisms for securing and documenting an independence declaration are not uniformly established across these forums. Consequences of Procedural Inconsistency This creates a notable gap. Not all arbitration bodies have a formalized procedure requiring written independence statements before proceedings commence. Some tribunals proceed directly to the first procedural

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 to support food product

Thailand’s Securities and Exchange Commission (SEC) has released a detailed draft notification expanding its oversight to cover the funding sources behind major shareholdings in licensed securities and digital asset business operators. Published on June 8, 2026, as Public Hearing Document No. 30/2569, the draft builds on funding-source principles introduced in an April hearing and on recently amended Ministry of Finance notifications issued in February 2026 that broadened the definition of major shareholder of licensed securities and digital asset business operators. A public comment period on the draft closes on June 23, 2026. An earlier version of the SEC’s proposal brought the issue of funding behind significant shareholdings within the SEC’s regulatory perimeter, signaling intent to look beyond shareholding to the persons and capital ultimately financing major shareholdings in licensed securities and digital asset business operators. The concern is that control may be exercised through financing arrangements rather than through equity ownership alone. The draft notification advances that initiative into a more detailed regulatory framework, as summarized below. Expanded Definition Captures Funding Sources Throughout Ownership Chains The draft regulation introduces a “material funding source” concept. A material funding source is the principal capital that enables a major shareholder to acquire its shareholding, without which the shareholding could not be obtained. Under the proposed rules, any person who provides such funding, whether directly to the major shareholder or indirectly through any tier of the ownership chain above the operator, is deemed a controller subject to SEC approval. The draft also captures any person acting as a conduit or intermediary in facilitating financial assistance to a major shareholder, deeming each of these persons to be a material funding source and aggregating it into the same control group as the ultimate funding source. The definition covers not only cash loans and equity investments, but also financial assistance provided

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 Medical Device Regulation). UDI details must be displayed as part of