In response to persistent challenges in food safety management and recent high-profile incidents involving counterfeit supplemented foods, infant formula, and health supplements, the Ministry of Health of Vietnam is initiating comprehensive regulatory reforms. These reforms include proposed amendments to the Law on Food Safety and its implementing Decree No. 15/2018/ND-CP (Decree 15), introducing significant changes to the registration procedures for food products, especially supplemented food products and health supplements. While awaiting public consultation and approval of the amended Law on Food Safety, the Ministry of Health is developing an interim mechanism, which includes a draft decree to replace Decree 15 and a draft resolution to address urgent issues until the amended law becomes effective, expected in July 2026. To align with the new Law on Quality of Products and Goods, the draft resolution stipulates that the declaration and registration of food products will follow the following procedures: Declaration of applied standards for food products, which is currently known as the “self-declaration” procedure, applies to processed packaged foods, food additives, food processing aids, containers or utensils that come into direct contact with food, packaging materials in direct contact with food, and micronutrients. Granting of circulation numbers, which is the current “registration of product declaration” procedure, applies to specific categories of food including health supplements, medical nutrition foods, special dietary foods, nutritional products for children up to 36 months, and, especially, supplemented foods, which are currently subject to self-declaration but will be shifted to this registration procedure. In addition, the following new procedure is introduced in the draft decree: Registration of declaration of conformity, which applies to the same product category as in “declaration of applied standards” above, but is for products that are already subject to technical regulations covering both safety indicators and quality indicators. Changes to the Food Product

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

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

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