Vietnam Profile Updated

The Vietnam profile in ClinRegs has been reviewed and updated as follows:

• Revision of information on clinical trial phase exemption criteria (See Scope of Assessment)
• Reorganization of the information included in Scope of Assessment, Scope of Review, and Risk & Quality Management
• Inclusion of bioequivalence testing regulations that took effect in November 2022 (See Scope of Assessment)

Sources Added During this Update:

(Regulation) Circular No. 08/2022/TT-BYT – Regulations on Registration for Circulation of Drugs and Medicinal Ingredients (DrugRgstrtn – Vietnamese) (Effective October 20, 2022)
Ministry of Health

(Regulation) Circular No. 07/2022/TT-BYT – Regulations on Drugs Subject to Bioequivalence Testing and Requirements for Records and Reports on Bioequivalence Research Data (BioTestReq – Vietnamese) (Effective November 1, 2022)
Ministry of Health

Sources Revised During this Update:

(Not Available Online) NIAID Communication with VietStar Biomedical Research (April 2023) (VNM-12)