Drug Administration of Vietnam

The Drug Administration of Vietnam (Cục Quản lý Dược) receives and assesses applications to market medicines in Viet Nam, issues and renews registration certificates, and publishes decisions such as its lists of originator medicines and reference biologicals. An advisory council set up by the Minister of Health reviews the expert assessments.

Circular 32/2026/TT-BYT of 29 July 2026, in force from 1 October 2026 and issued under the Law on Pharmacy as amended by Law No. 44/2024/QH15, sets the time to process an application from receipt: no more than 12 months for a medicine, no more than 9 months where the application relies on the assessment of a reference regulator, no more than 6 months for priority cases defined in the Law on Pharmacy, and 15 days for a new medicine against a declared group A epidemic. The reference regulators are the European Medicines Agency and the stringent regulators listed in the circular: the US FDA, the regulators of European Union countries, the United Kingdom's MHRA, Japan's PMDA, Swissmedic, Health Canada, and Australia, Iceland, Liechtenstein and Norway. A relying application must include the reference regulator's final assessment report and a table comparing the Vietnamese dossier with the approved product.

A new medicine (other than a vaccine) can be exempted from clinical trials in Viet Nam if it is approved in at least one country, has complete clinical data and enough information to analyse the effect of Asian ethnicity on safety and efficacy under ICH E5. A first registration of a new medicine, vaccine or biological is valid for 3 years; most others for 5. These are maximum processing times in the rules, not measured approval times. The live site reset our connection on 4 November 2026 and was read through the Internet Archive.