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 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

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

Tilleke & Gibbins attorneys in Vietnam have contributed the 2025 edition of Doing Business in Vietnam, a comprehensive Q&A-style resource from Thomson Reuters Practical Law that provides essential insights for companies navigating business operations in Vietnam. The guide presents a detailed overview of the country’s legal framework and regulatory environment, reflecting recent updates in Vietnamese legislation and practice. This annually updated guide offers key information on the following areas: Legal system: Structure of the Vietnamese judiciary and the role of codified law. Foreign investment: Conditions for market access, licensing requirements, foreign ownership restrictions, and investment incentives. Business vehicles: Formation and operation of legal entities, including limited liability companies, joint-stock companies, and representative offices. Employment: Employment contracts, social insurance, labor rights, and procedures for hiring foreign nationals. Tax: Overview of corporate income tax, personal income tax, value-added tax, and other tax obligations. Intellectual property: Procedures for protecting and enforcing patents, trademarks, copyrights, and other IP rights. Data protection: Compliance requirements under Vietnam’s data privacy laws, including the Personal Data Protection Decree. Competition law: Antitrust rules and regulatory oversight under the Law on Competition. Anti-bribery and corruption: Legal framework and enforcement practices aimed at curbing corrupt activities. E-commerce and digital business: Regulations governing online platforms, digital content, and cross-border services. Marketing and advertising: Laws and guidelines on advertising standards and consumer protection. Product regulation and liability: Safety requirements, product liability issues, and roles of relevant authorities. Doing Business in Vietnam is part of Practical Law’s global series of legal guides designed to support international practitioners and businesses. To access the most recent edition of the Vietnam guide, visit the Practical Law website and sign up for a free trial.