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.

Thailand’s Food and Drug Administration (FDA) has launched a strategic collaboration with leading e-commerce platforms Lazada and Shopee to strengthen regulatory oversight of health-related products sold online. This partnership is part of a broader initiative to enhance consumer protection, enforce compliance with Thai health regulations, and foster a safer digital marketplace for health products. As part of this initiative, the Thai FDA is urging all sellers—particularly cross-border vendors—to secure proper FDA registration for their products before market entry. The objective is to ensure that only legally authorized, safe, and quality-assured healthcare products are available to Thai consumers. In pursuit of this goal, the FDA has been working closely with Lazada and Shopee to implement proactive surveillance mechanisms aimed at identifying and removing noncompliant, substandard, or unregistered products. This collaboration has already yielded measurable results. Between September 2023 and 2024, Lazada supported regulatory enforcement by removing 9,454 noncompliant listings and delisting 30 vendors. In addition, 134 sellers were subjected to legal proceedings for regulatory violations. Shopee has taken a similarly rigorous stance, committing to the immediate removal of products found to be in breach of FDA regulations. The platform has also provided educational materials for merchants and implemented consumer complaint mechanisms to enhance accountability. Looking ahead, the Thai FDA plans to roll out a data integration system utilizing API technology, enabling seamless and secure exchange of regulatory data between the agency and e-commerce platforms. This system will be supported by comprehensive training for both Thai FDA officials and e-commerce staff, with a particular focus on the use of the Thai government’s Law Enforcement Request Portal, a secure communication channel for coordinating enforcement actions between government agencies and platform operators. Additionally, a joint product inspection framework is currently under development in partnership with Lazada and Shopee. This framework will incorporate strict

On May 16, 2025, Vietnam’s Ministry of Health (MOH) issued Circular No. 12/2025/TT-BYT on registration of drugs and drug materials (Circular 12). Circular 12 will come into effect on July 1, 2025, replacing Circular No. 08/2022/TT-BYT (as amended), which provides the current regulations on drug registration, along with Circular No. 16/2023/TT-BYT on registration of drugs under toll manufacturing and technology transfer, and Circular No. 07/2017/TT promulgating the list of non-prescription drugs. Some of the key stipulations of Circular 12 are outlined below. Regulation of non-prescription drugs Circular 12 abolishes the detailed list of over-the-counter (OTC) drugs previously stipulated in Circular No. 07/2017/TT-BYT. Instead of relying on a fixed list for classification, Circular 12 introduces a new framework based on principles, criteria, and specific methods for determining the status of non-prescription/OTC drugs. This approach aims to enhance safety, ensure timely access, reflect actual usage and supply conditions, and align with international standards. Drugs that have already been approved will retain their classification (i.e., as prescription or non-prescription) throughout the validity of their marketing authorization (MA), and reclassification will be considered when the MA is renewed. If a change in classification is requested, the MA holder must submit a variation registration dossier to the Drug Administration of Vietnam (DAV). For drug registration dossiers currently under evaluation by the DAV, the classification will be assessed in accordance with the new provisions set out in Circular 12. Drug registration The new regulations under Circular 12 loosen the requirements on providing a Certificate of Pharmaceutical Product (CPP). For all drug registration cases, a single CPP will suffice, provided it is issued by the competent authority of the manufacturing country or by an authority from a country that is a member of the European Medicines Agency (EMA) or a Stringent Regulatory Authority (SRA), and confirms

Vietnam’s Ministry of Health (MOH) has published for public consultation a draft amendment of the Law on Donation, Recovery, and Transplantation of Human Tissues and Organs and Donation and Retrieval of Cadavers, a law which has been in effect since 2007. Among its changes, the draft amendment notably includes new provisions on stem cells, a hot-button topic with social, legal, and ethical ramifications extending beyond the medical field. There are currently no specific regulations on stem cells under Vietnamese law—only the MOH’s technical guidance—leaving many controversial issues unsettled. Key points related to stem cells that may impact the activities of researchers and institutions in Vietnam and abroad are highlighted below. Requirements for Stem Cells Under the draft amendment, stem cells are defined as cells naturally occurring in the body, having the ability to divide and differentiate into various types of cells. The draft amendment outlines conditions for stem cell donation, establishes requirements for medical facilities authorized to receive stem cell donations, and specifies the rights of stem cell donors. Under the draft amendment, it is prohibited to receive, screen, or produce stem cells at facilities that do not satisfy conditions. Establishment of Private Stem Cell Banks In addition to state-owned stem cell banks, the draft amendment also addresses independent stem cell banks established by private investors. In general, the stem cell banks (whether public or private) must obtain an operation license by meeting various conditions on personnel, equipment, facilities, and management systems to be further guided by the government. Notably, stem cell banks will have the right to cooperate with foreign entities in exchanging stem cells for treatment, education, and research purposes. Prohibition on Creating Embryos for Stem Cell Research or Therapy Considering the ethical concerns over the use and destruction of embryos, the draft amendment expressly prohibits the