Vietnam’s political system is currently undergoing a significant reorganization to streamline government operations and improve efficiency. In this regard, Plan 141/KH-BCDTKNQ18, issued on December 6, 2024, provided guidelines on the restructuring of existing ministries, ministerial-level agencies, and government-affiliated agencies. Accordingly, the number of ministries is being reduced from 18 to 14 through mergers and consolidations and the establishment of a new Ministry of Ethnic and Religious Affairs. The number of ministerial-level agencies is being reduced to three, and government-affiliated agencies to five. Similar streamlining is happening at provincial levels. The newly consolidated state agencies will assume all functions, rights, and responsibilities of the merged entities, and will continue handling all ongoing matters previously handled by the former agencies. Some examples of these changes include the following: The Ministry of Science and Technology (MOST) will oversee telecommunications, IT applications, cybersecurity, e-transactions, and national digital transformation, which had previously been managed by the Ministry of Information and Communications (MIC). MOST will also be responsible for issuing licenses related to these areas, such as licenses for G1 online game services and telecommunication services. The Ministry of Culture, Sports, and Tourism will assume the responsibility of press management, previously under the MIC. The Ministry of Finance will assume state management functions related to investment, previously handled by the Ministry of Planning and Investment. Provincial Departments of Finance will issue Investment Registration Certificates and Enterprise Registration Certificates, a responsibility previously held by the Departments of Planning and Investment. The Ministry of Home Affairs will oversee labor and employment matters. Provincial Departments of Home Affairs will be authorized to issue work permits and will be the designated authorities for companies to register their internal labor regulations. Advantages for Businesses The restructuring aims to simplify regulations and expedite licensing processes. By reducing the number of agencies

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.

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