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 June 26, 2025, the National Assembly of Vietnam adopted Resolution No. 216/2025/QH15 to extend the duration of agricultural land use tax exemption through December 31, 2030. This policy extension reaffirms the government’s ongoing efforts to support the agricultural sector, ensure national food security, and promote rural development. Key Takeaways Tax Exemption Period Extended: The new resolution continues the full exemption from agricultural land use tax as stipulated under Resolution No. 55/2010/QH12, as amended in 2016 and 2020. The tax exemption, which was originally set to expire at the end of 2025, will now remain in effect until December 31, 2030. Scope of Exemption: The exemption applies to all types of land currently eligible under the existing legal framework for agricultural land use tax relief. This typically includes land used by households, cooperatives, and non-commercial organizations for agricultural production, aquaculture, salt-making, and reforestation. Effective Date: Resolution 216 will take effect on January 1, 2026. During the interim period, tax exemption remains valid under existing laws and resolutions until the end of 2025. Implementation Guidance to Follow: The government is tasked with issuing detailed guidance to ensure effective implementation of this extended exemption. Businesses, cooperatives, and individuals engaged in agricultural activities should monitor upcoming regulations and instructions from relevant ministries. Outlook Vietnam’s extension of agricultural land use tax exemption demonstrates a strong policy commitment to rural economic stability and environmental sustainability. For land users, the exemption represents meaningful financial relief that can be reinvested into modernizing farming techniques, improving land efficiency, or transitioning to sustainable practices. While the extension itself is automatic, it is recommended that agricultural land users and stakeholders review their land use documentation and tax profiles to ensure alignment with eligibility requirements. Future implementation regulations may also introduce new compliance obligations that should be tracked closely.

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