On July 1, 2025, Vietnam’s Ministry of Health issued Circular No. 30/2025/TT-BYT providing updated guidance on the application of drug quality standards, testing of drugs and pharmaceutical ingredients, and procedures for the recall and handling of noncompliant drugs (Circular 30). Circular 30 officially came into effect on the same day and replaces Circular No. 11/2018/TT-BYT and its amendments. Key highlights of Circular 30 are presented below. Drug and Pharmaceutical Ingredient Quality Standards Circular 30 maintains consistency with previous regulations regarding the selection of an applicable quality specification. Pharmaceutical businesses and drug preparation establishments may still choose to apply standards from the Vietnamese Pharmacopoeia, reference pharmacopoeias (including the United States Pharmacopoeia, the European Pharmacopoeia, the British Pharmacopoeia, the Japanese Pharmacopoeia, and the International Pharmacopoeia), or an in-house specification. Priority is given to the Vietnamese Pharmacopoeia and reference pharmacopoeias, encompassing quality indicators, quality levels, and testing methods. If alternative pharmacopoeias or in-house specifications are used, they must meet the requirements outlined in the corresponding monographs of the Vietnamese or reference pharmacopoeias. At the time of registration, the quality standards of drugs and pharmaceutical ingredients must comply with either the current version of the pharmacopoeia or a previous version of the pharmacopoeia that is no more than two years older than the current version. The requirement for updating quality specifications in line with the quality under the corresponding pharmacopoeia also applies to products that have already been granted marketing authorization. Testing Drugs and Pharmaceutical Ingredients in Quality Management Similar to the regulations under the previous circular, if pharmaceutical businesses disagree with the sample testing results, they may, within five working days of receiving the test report, request that the state quality inspection authority designate an alternative testing facility. The testing period for establishments listed as foreign drug manufacturers with quality violations remains

Thailand has established new safe harbor rules that require social media platforms to remove specified content within 24 hours of government notification. On July 5, 2025, the Notification of the Electronic Transactions Commission on Measures to Prevent Technological Crimes for Social Media Service Providers was issued and took effect. This followed a hearing in May 2025 where only a select group of social media and online communication platform operators were invited to attend and comment on draft rules that could exempt social media platform operators from joint liability under the amended Emergency Decree on Measures for the Prevention and Suppression of Technological Crimes in cases involving victims of technological crimes. Safe Harbor Rules The notification stipulates procedures that must be followed in order to receive the protection of the safe harbor rules. Upon being notified by the Division of Prevention and Suppression of Cybercrime, Office of the Permanent Secretary of the Ministry of Digital Economy and Society (MDES) of the presence of false or misleading information that may lead to the commission of a technological crime, social media service providers must immediately take down the specified content, with a maximum allowable turnaround time of 24 hours from the time of receiving the notification. Social media service providers are required to promptly report the outcome of each takedown to the MDES Division of Prevention and Suppression. This shift in Thailand’s regulatory approach to social media content moderation establishes clear government oversight mechanisms while providing platforms with liability protection for compliance. As the new rules took immediate effect, social media platforms need to ensure that they have adequate systems and processes in place to comply with the requirements.

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

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