Vietnam Profile Updated
The Vietnam profile in ClinRegs has been reviewed and updated with the following information:
- Updated regulation and additional webpage on the establishment and operations of ethics committees (See the Ethics Committee topic and Submission Content, Timeline of Review, and Progress Reporting)
- Additional regulation and information on the Administration of Science, Technology and Training’s initial and ongoing good clinical practice assessments (See Scope of Assessment and Risk & Quality Management)
- Updated regulation on the criteria for drug circulation registration with a clinical trial exemption (See Scope of Assessment)
- References to a July 2025 data law (See Personal Data Protection)
- Updated regulation on the functions, tasks, powers, and organizations structure of the Ministry of Health, which underwent minor revisions (See Requirements)
Sources Added During this Update:
(Legislation) Law No. 60/2024/QH15 on Data (DataLaw-VNM – Vietnamese) (Effective July 1, 2025)
The National Assembly
(Regulation) Plan for Appraisal of Initial Assessment Records and Assessment of Maintenance of Compliance with Good Clinical Practice in 2024 (ASTT-GCPAssess – Vietnamese) (Effective September 24, 2024)
Ministry of Health
(Webpage) Standard Operating Procedures (SOPs) of the National Ethics Committee in Biomedical Research (VNM-14 - Vietnamese) (Last Updated December 2, 2019)
Administration of Science, Technology and Training, Ministry of Health
Sources Revised During this Update:
(Regulation) Circular 12/2025/TT-BYT – Regulations on Registration of Drugs and Medicinal Ingredients (DrugRgstrtn – Vietnamese) (Effective July 1, 2025)
Ministry of Health
(Regulation) Circular No. 43/2024/TT-BYT – Regulations on the Establishment, Organization, and Operation of the Ethics Committee in Biomedical Research (ECReg – Vietnamese) (Effective February 1, 2025)
Ministry of Health
(Regulation) Decree 42/2025/ND-CP – Regulations on the Functions, Tasks, Powers and Organizational Structure of the Ministry of Health (DecreeMOH – Vietnamese) (Effective March 1, 2025)
Socialist Republic of Vietnam