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

Attorneys from Tilleke & Gibbins have updated the latest edition of Doing Business in Thailand, a Q&A-style guide from Thomson Reuters Practical Law that offers an overview of key legal considerations for companies operating in jurisdictions worldwide. The contribution outlines the country’s legal and regulatory framework for foreign investment and business operations and reflects the latest legislative developments. The chapter addresses the following core topics: Legal system: Structure of the courts and the codified nature of Thai law. Foreign investment: Business restrictions under the Foreign Business Act, sector-specific regulations, exchange control rules, and investment incentives. Business vehicles: Overview of partnerships, private and public limited companies, and other legal entities. Employment: Labor protections, employment contracts, foreign worker requirements, and termination procedures. Tax: Corporate and personal income tax, indirect taxes, and tax obligations for residents and non-residents. Intellectual property: Registration and enforcement of patents, trademarks, designs, and copyrights. Data protection: Key provisions of the Personal Data Protection Act and related compliance obligations. Competition law: Regulatory framework under the Trade Competition Act. Anti-bribery and corruption: Relevant legislation and enforcement mechanisms. E-commerce and digital business: Legal regime for online transactions and digital platforms. Marketing and advertising: Consumer protection laws and regulations affecting advertising and marketing practices. Product regulation and liability: Safety standards, liability regimes, and roles of enforcement authorities. Practical Law, a legal reference resource from Thomson Reuters, publishes a range of guides for hundreds of jurisdictions and practice areas. The insurance and reinsurance guide is a valuable resource for legal practitioners, covering numerous jurisdictions worldwide. To view the latest version of the guide, please visit the Practical Law website and enroll in the free Practical Law trial to gain full access.

On November 22, 2024, the Ministry of Health (MOH) in Laos issued Decision No. 3730/MOH, which regulates the management, processing, production, and use of biopharmaceutical products, genes, and stem cells. This decision came into force on January 18, 2025, 45 days after its publication in the Lao Official Gazette on December 4, 2024. This decision signifies Laos’ recognition and acceptance of biopharmaceutical products, genes, and stem cells for use in medical treatments and the beauty industry, and it aligns with the ongoing development of biomedical sciences in the country. Definitions The MOH’s decision defines biopharmaceuticals, gene therapy, and stem cells as follows: “Biopharmaceutical products” refers to a type of biological or drug product that is produced or synthesized from natural substances, objects, or chemicals. This group of products includes blood, blood components, allergens, cells or cellular components, gene therapies, tissues, protein-based medicines, drugs derived from living cells, and biologics, which can be produced from sugars, proteins, amino acids, or substances with complex characteristics derived from organic sources such as human, animal, and plant parts; yeast; and microorganisms. These products exclude vaccines and biosimilar products, which will be specified under separate regulations. “Gene therapy” refers to a treatment approach that applies the principle of arranging amino acids (which could involve DNA or RNA sent to the patient’s cells in the form of a drug with the purpose of treating a certain disease). “Stem cells” are defined in the decision as cells or immature cells that can be sourced from various organs in the They are characterized by being undifferentiated, having the potential for differentiation, and being self-renewing. Stem Cell Production The decision outlines comprehensive provisions for managing and using raw materials in stem cell production. Key points include: Production location standards: Ensuring facilities meet specific standards of the MOH. Personnel