Life sciences specialists from Tilleke & Gibbins have updated the firm’s guide to pharmaceutical data exclusivity regulations and practices in Southeast Asia. This guide contains quick-reference information on the availability of data exclusivity protections and limitations in Cambodia, Indonesia, Laos, Malaysia, Myanmar, Thailand, and Vietnam. Developing and launching a new drug on a commercial scale requires an enormous amount of time and investment in research and development (R&D), including pre-clinical testing and clinical trials. When considering the aggregate amount of drug development costs, it is important to recognize that this includes not only the investment in developing new drugs that get approved by a government food and drug regulator and are successfully brought to market, but also the R&D expenditures on a large number of potential pharmaceutical compounds and products that never actually make it to market. In particular, considerable investment is required in order to conduct and produce clinical trial data—to prove safety, efficacy and effectiveness of a new drug—that would warrant marketing approval by the regulatory authority. Such data is proprietary in nature and highly valuable for a research-based pharmaceutical company that develops an original drug. On the other hand, patent law typically confers generic drug manufacturers with the ability to engage in various preparatory activities with a view to obtaining marketing approval for a generic product before the patent for the original drug expires (commonly known as a “Bolar provision”). Since a generic drug maker may submit an application for marketing approval of a generic product before the relevant patent expires, the extent to which the drug originator’s data submitted to the regulatory authority is protected—or in other words, the extent to which the generic company may rely on the drug originator’s previously filed data, which underpins the safety and efficacy of the drug, to support the generic

Vietnam’s recent embrace of “regulatory sandboxes” reflects a deliberate policy choice to balance the need for robust oversight with an equally pressing imperative to catalyze innovation. A sandbox is a controlled, time-bound framework in which businesses may pilot emerging technologies, products, or business models under relaxed or tailor-made regulatory requirements, thereby allowing regulators to observe risks in real time while innovators validate commercial viability without bearing the full weight of the traditional compliance regime. By issuing sandbox regulations, the government of Vietnam is signaling its commitment to accelerating digital transformation, attracting investment, and developing a knowledge-based economy, all while safeguarding financial stability, consumer protection, and national security. This strategy is embodied in a suite of instruments that together establish sector-specific sandboxes: Decree No. 94/2025/ND-CP on the Regulatory Sandbox in the Banking Sector (Fintech Sandbox Decree), effective July 1, 2025. Law on Digital Technology Industry (DTI Law), effective January 1, 2026, and Law on Science, Technology and Innovation (STI Law), effective October 1, 2025. Resolution No. 222/2025/QH15 on International Financial Centers (IFC Resolution), effective September 1, 2025. In addition, a draft resolution on the pilot implementation of the crypto-asset market (Draft Crypto Pilot Resolution) is expected to introduce a dedicated sandbox for crypto-asset service providers later this year, further underscoring Vietnam’s holistic, forward-looking approach to regulating emerging technologies. Below is a brief summary of all the regulatory sandboxes, who they are open for, and what businesses are attracted. Fintech Sandbox Decree Under the Fintech Sandbox Decree, besides credit institutions and foreign bank branches, fintech companies operating in Vietnam can apply for a Certificate of Sandbox Participation issued by the State Bank of Vietnam to operate any of the following services in Vietnam: Credit scoring: A solution applicable to information technology systems of credit institutions, branches of foreign banks, and fintech companies to score the creditworthiness of an individual or

On June 10, 2025, Thailand’s Supreme Administrative Court accepted for consideration a pivotal lawsuit concerning the regulatory obligations of administrative agencies over internet-based television broadcasting services, commonly referred to as over-the-top (OTT) services. This court’s decision in the case may set important precedents for how OTT platforms are regulated, especially regarding consumer protections and advertising practices. Background A user of an OTT television application initiated legal action against the National Broadcasting and Telecommunications Commission (NBTC) and related officials, alleging that the lack of clear regulatory criteria and oversight allowed OTT operators to broadcast general television content while compelling users to view advertisements before and during programming. The plaintiff argued this constituted consumer exploitation and claimed that the responsible authorities neglected or delayed their statutory duties under the Act on the Organization to Assign Radio Frequencies and Regulate Broadcasting, Television, and Telecommunications Services B.E. 2553 (2010). Initially, the Central Administrative Court declined to accept the lawsuit. However, on appeal, the Supreme Administrative Court determined that the claim fell within its jurisdiction, noting that OTT television services—defined under section 4 of the governing act—are subject to the same regulatory framework as traditional television services, regardless of the transmission method (frequency, cable, internet, or other system). Implications for OTT Services The key implications for OTT services concern the following issues: Regulatory oversight: The court recognized that OTT television services are explicitly covered under Thailand’s broadcast regulatory regime. Regulatory agencies may be compelled to establish clear operational rules and oversight mechanisms for OTT providers. Consumer protections: The plaintiff’s claim that excessive or unavoidable in-program advertising constitutes consumer exploitation was acknowledged as a matter of public interest. This may prompt stricter advertising standards for OTT platforms. Licensing requirements: The case raises the prospect that OTT operators may be required to obtain licenses from the NBTC, ensuring that such services are brought fully

For companies and individuals doing business in Vietnam, a common question is whether electronic signatures (e-signatures) are legally recognized under Vietnamese law. This matter is governed by Law No. 20/2023/QH15 on Electronic Transactions issued on June 22, 2023 (ETL 2023) and its guiding legal documents such as Decree No. 23/2025/ND-CP dated February 21, 2025, and Circular 06/2024/TT-BTTTT dated July 1, 2024 (Circular 06). Recognition of Validity of E-signatures in Vietnam As a general principle, the ETL 2023 confirms that an e-signature cannot be denied legal validity solely due to its electronic form. The law categorizes e-signatures into three types: Type 1: Specialized e-signatures for organizations Type 2: Public digital signatures for individuals and organizations Type 3: Specialized digital signatures for government agencies Among these types, only secure specialized e-signatures (a secure e-signature of type 1) and digital signatures (type 2) are explicitly granted the same legal validity as handwritten (wet) signatures. This distinction is particularly important in legal disputes and for transactions with government agencies. (For more details, please refer to our previous article.) Domestic e-signatures A domestic organization can choose to use secure specialized e-signatures (type 1) and/or digital signatures (type 2) while a Vietnam-based individual can choose digital signatures (type 2) for their transactions—particularly for those involving government agencies and transactions of high value and complexity which require stronger legal protection. Specialized e-signatures (type 1) can be created by the organizations themselves, and additionally must be “secure” to be explicitly recognized as having the same legal validity as handwritten signatures. For clarity, “secure” specialized e-signatures are those certified (granted a safety certificate) by the Ministry of Science and Technology (MST). (This was formerly the responsibility of the Ministry of Information and Communications, which was merged with MST under Vietnam’s 2025 administrative restructuring.) Digital signatures (type 2) are issued to organizations and individuals by licensed public digital signature

On June 16, 2025, the National Assembly of Vietnam adopted Law No. 75/2025/QH15 amending and supplementing a number of articles of the 2012 Advertising Law, with an effective date of January 1, 2026. The amended Advertising Law was enacted to further refine the legal framework for advertising activities in the modern era. Online Advertising Under the amended Advertising Law, “online advertising” is defined to encompass not only advertising on electronic newspapers and electronic information pages (as provided under the 2012 Advertising Law) but also advertising on other electronic venues, including social media, online applications, and digital platforms with internet connection. The amended Advertising Law also imposes new requirements for online advertising, including: Identification signs: Advertisements must have clear identifiable signs in numbers, letters, symbols, images, or sounds to distinguish them from non-advertising content. Control features: For advertisements not in fixed areas, there must be easily recognizable features and icons that allow recipients to turn off the advertisement, notify the service provider of violating advertising content, and refuse to view inappropriate advertising content. Linked content: Content in the links embedded in advertisements must comply with the law. Advertising service providers and publishers must have measures to check and monitor the linked content. Advertising on social media: Organizations and enterprises providing social media services must offer users features to distinguish advertising content from other content. Signage for sponsored content: When advertising, users of social media services must use signs to differentiate advertising or sponsored content from other content they provide. In response to the above requirements for online advertising, the amended Advertising Law sets out obligations of advertisers, advertising service providers, advertising publishers, and advertising conveyors in relation to online advertising. Among these, it is notably the responsibility of individuals and organizations engaging in online advertising to prevent and remove violating advertisements within 24 hours upon receiving requests from authorities. Responsibilities

The final article in our series analyzing the recent European blackout and its implications for Thailand. It presents key lessons for Thailand on strengthening its energy system to prevent similar disruptions in the future.

On July 3, 2025, Vietnam’s Ministry of Health (MOH) issued Circular No. 34/2025/TT-BYT amending some articles of Circular No. 06/2011/TT-BYT on the management of cosmetics products (Circular 34), which provides the current regulations on the product notification process for cosmetics (cosmetic notification). Circular 34 will come into effect on August 18, 2025. Changes to Cosmetic Notification Some of the key stipulations of Circular 34 are outlined below. Addition of submission route for notification Circular 34 officially adds online submission via the National Public Service Portal as an accepted type of cosmetic notification, in addition to direct submission and submission via post. Clearer regulations on preparing cosmetic notification form Circular 34 provides clarification on the signing requirements for cosmetic notification forms. For online submissions, both e-signatures and digital signatures are accepted. For offline submissions, the circular explicitly states that stamped/generated signatures are not acceptable. There are no substantive changes to existing requirements regarding grouping of products in a single declaration, ingredient listing, or language used in the notification form. Circular 34 only introduces formatting adjustments to these provisions. Updated administrative procedures Circular 34 updates requirements on digital procedures and authentication for online submission with references to new government decrees. In addition, processing timelines for cosmetic notification are further clarified, in particular, five working days for feedback on incomplete dossiers and five working days for approval after receiving complete supplemental dossiers. Revised requirements for import of samples for testing and research An updated Appendix 14-MP form is introduced with Circular 34, in which the receiving authority is updated from the Drug Administration of Vietnam to the specialized health agency under the provincial People’s Committee. Both online and direct submission of the request are allowed. The approval timeline is three working days from the date of reviewing the request. Transition clause Notifications submitted before Circular 34 takes effect (August

On June 29, 2025, the government of Vietnam issued Decree No. 163/2025/ND-CP providing detailed guidance on the implementation of the amended Law on Pharmacy (Decree 163). Decree 163, like the amended Law on Pharmacy, took effect on July 1, 2025, officially replacing Decree No. 54/2017/ND-CP (Decree 54). The new decree introduces comprehensive regulations across key areas of pharmaceutical management such as pharmacy practice certificates, certificates of eligibility for pharmaceutical business, import and export of drugs and drug materials, GMP inspection of foreign manufacturers, drug and drug material recall, certificates of drug advertising content, and drug price management. Key Changes in Decree 163 Some outstanding changes and additions in Decree 163 are presented below. Destruction of Specially Controlled Drugs It is no longer required to obtain approval from the competent authority before the destruction of narcotic, psychotropic, and precursor drugs, and pharmaceutical ingredients that are narcotic or psychotropic substances, or precursors used in drugs. Instead, notification must be provided at least seven working days in advance, including the proposed destruction date and a detailed list of items to be destroyed. E-commerce in Pharmaceuticals Pharmaceutical businesses operating via e-commerce platforms must publicly disclose the following information to ensure transparency and consumer safety: (i) certificate of eligibility for pharmaceutical business, (ii) pharmacy practice certificate of the person responsible for pharmaceutical expertise, and (iii) drug information. Shelf-Life Requirements for Imported Products For drugs and ingredients with a total shelf life of nine months or less, at least one-third of the shelf life must remain at the time of customs clearance. Drugs with a shelf life of 30 days or less must still be within their shelf life at the time of clearance. Control of Imported Products Drugs subject to import control include all drugs with marketing authorization (MA), except for (i) drugs that meet the needs of prevention and treatment of group-A infectious