Experts from Tilleke & Gibbins have provided updates for the latest edition of The Pharma Legal Handbook: Vietnam, published by Pharma Boardroom. This comprehensive guide to the legal framework regulating the healthcare and life sciences industries in Vietnam was authored by by the Hanoi-based team of Hien Thi Thu Vu, head of regulatory affairs for Vietnam, and Mai Thi Le, regulatory affairs consultant, the handbook is a must-read for healthcare and life sciences companies that are interested in the Vietnam market. The guide includes eight sections on various important aspects of local regulations: Regulatory, Pricing, and Reimbursement Overview Preclinical & Clinical Trial Requirements Marketing, Manufacturing, Packaging & Labeling, and Advertising Traditional Medicines and Over-the-Counter Products Product Liability Patents and Trademarks Regulatory Reforms Orphan Drugs and Rare Diseases Tilleke & Gibbins has also authored The Pharma Legal Handbook: Thailand, which was updated at the same time as the Vietnam guide. The Pharma Legal Handbook: Vietnam, like all of the country guides from Pharma Boardroom, is available for purchase on the Pharma Boardroom website.

Attorneys from Tilleke & Gibbins in Bangkok have provided updates for the latest edition of The Pharma Legal Handbook: Thailand, published by Pharma Boardroom. This comprehensive guide to the legal framework regulating the healthcare and life sciences industries in Thailand was authored by Alan Adcock, partner and director, intellectual property, and head of the firm’s life sciences practice; Dr. Atthachai Homhuan, manager of regulatory affairs; and San Chaithiraphant, senior associate. The handbook is a must-read for healthcare and life sciences companies that are interested in exploring expansion into the Thai market.

Vietnam is a world leader in blockchain adoption and growth, appearing near the top of most rankings of cryptocurrency ownership and blockchain investment. Although the country has taken a cautious approach toward cryptocurrency (banning the use of cryptocurrencies like Bitcoin as a means of payment, for example), the government actively supports blockchain technology and its applications in non-financial sectors. Recognizing blockchain as a core technology of the Fourth Industrial Revolution, as a part of Vietnam’s broader digital transformation agenda, the government issued Decision No. 1236/QD-TTg on October 22, 2024, providing the National Strategy for Blockchain Application and Development to 2025, with Orientation to 2030. Like the National Strategy on Digital Infrastructure, the National Strategy on Blockchain outlines a very ambitious vision to position Vietnam as a regional leader in blockchain technology. The strategy aims for Vietnam to master and apply blockchain across all socio-economic sectors, supporting the nation’s goal of becoming a stable and prosperous digital nation by 2030. The specific goals set for 2025 include developing Vietnam’s blockchain infrastructure and ensuring compliance with cybersecurity and data protection laws; advancing blockchain research through three national innovation centers; building and upgrading 10 facilities dedicated to blockchain research and workforce training; and expanding blockchain education by integrating it into university programs. The strategy also aims to establish at least one blockchain center, special zone, or area, as a pilot, to build a national blockchain network; and foster a blockchain ecosystem by promoting its application across sectors such as banking and finance, transportation, healthcare, education and training, commerce, logistics, postal services, industrial production, energy, tourism, agriculture, public services, and more. The goals for 2030 include strengthening Vietnam’s national blockchain infrastructure to support both domestic and international services, positioning Vietnam as a global and regional leader in blockchain research, application, and development. The

On November 21, 2024, the National Assembly of Vietnam adopted a law amending and supplementing the 2016 Law on Pharmacy (“Amended Law on Pharmacy”). The Amended Law on Pharmacy simplifies some procedures for the pharmaceutical field, and will take effect on July 1, 2025, except for regulations on drug registration and rights and responsibilities of certain types of pharmaceutical business. Some outstanding points in the Amended Law on Pharmacy are presented below. E-commerce Distribution The Amended Law on Pharmacy allows trading in pharmaceutical products by the e-commerce channel, including e-commerce trading floors, e-commerce sales applications, and e-commerce sales websites with online ordering functions. Accordingly, e-commerce retail of non-prescription drugs is permitted if the drugs are neither specially controlled drugs nor drugs included in the list of drugs restricted for retail sale, and e-commerce wholesale of drugs and drug materials is permitted, as long as they are not specially controlled drugs. New Rights for Import FIEs The amendment provides some additional rights to foreign-invested enterprises (“FIEs”) that import drugs, including the rights to: Repurchase drugs and drug materials manufactured through the technology transfer of the FIE itself in Vietnam, and sell such products to wholesalers; Import drug materials to supply to drug manufacturers in Vietnam that are hired by or receive technology transfer from the FIE itself under a processing contract or technology transfer contract; Deliver and transport drugs and drug materials the FIE has imported, outsourced for processing, or transferred technology for in Vietnam, from the FIE’s warehouse to its wholesalers; Deliver and transport drugs used in aid, sponsorship, humanitarian, and disease prevention and control programs to medical facilities receiving funding; and Transport drug materials imported by the FIE from its warehouse to drug manufacturers that are hired by or receive technology transfer from the FIE itself under a