Regulatory Update: Decision No. 629/QĐ-QLD on Renewing Marketing Authorization for Vaccines and Biological Products

Decision No. 629/QĐ-QLD, issued by the Drug Administration of Vietnam (DAV) on October 31, 2025, officially announces the list of 05 Vaccines and Biological Products (vắc xin, sinh phẩm) that…

Regulatory Update: Decision No. 359/QĐ-QLD on Issuing a List of Foreign Drugs Approved for Marketing Authorization

Decision No. 359/QĐ-QLD, issued by the Drug Administration of Vietnam (DAV) on July 17, 2025, officially announces the list of 103 foreign-manufactured drugs that have been successfully granted or renewed…

Regulatory Update: Circular No. 30/2025/TT-BYT on Quality Standards, Testing, and Recall of Drugs

Circular No. 30/2025/TT-BYT, issued by the Ministry of Health on July 01, 2025, provides detailed instructions for applying quality standards, testing, and managing the recall and disposal of non-compliant drugs…

Regulatory Update: Circular No. 28/2025/TT-BYT on Procedures for Drug Registration (Marketing Authorization)

Circular No. 28/2025/TT-BYT, issued by the Ministry of Health on July 10, 2025, sets forth comprehensive regulations concerning the dossiers and procedures for applying for, re-issuing, renewing, modifying, supplementing, and…

Regulatory Update: Circular No. 31/2025/TT-BYT on Drug Labeling and Package Inserts

Circular No. 31/2025/TT-BYT, issued by the Ministry of Health on August 15, 2025, provides comprehensive regulations on the content and presentation of drug labeling and package inserts (Patient Information Leaflets).…