Vietnam
Drug Administration of Vietnam (DAV)
Vietnam regulates pharmaceutical products through the Drug Administration of Vietnam (DAV, Cục Quản lý Dược), an agency of the Ministry of Health (MoH). The legal framework is the Pharmacy Law 2016 (No. 105/2016/QH13, as amended in 2024 by Law No. 44/2024/QH15) and subordinate Decrees and Circulars. Marketing authorisation is evidenced by a Visa (Số đăng ký lưu hành thuốc), valid for 3 or 5 years depending on product class. DAV's procedures were modernised by Circular 08/2022/TT-BYT (which simplified administrative procedures and allowed renewals via auto-extension), and most recently updated by Circular 12/2025/TT-BYT (issued 16 May 2025) which further refines registration and lifecycle requirements. Vietnam is an ASEAN member and applies ACTD/ACTR; it operates Standard, Generic, Vaccine/Biological and Reliance / SRA-recognition pathways. Public-sector reimbursement is anchored on the Vietnam Social Security (VSS) scheme administered by the Vietnam Social Security agency, with the Ministry of Health Drug List (Reimbursement List, Thông tư 20/2022/TT-BYT and successors) as the gatekeeper for VSS coverage. Centralised procurement at MoH and provincial Department of Health levels drives hospital-channel access.
About the authority
DAV is the national regulatory authority for medicines in Vietnam, operating as a department of the Ministry of Health. It administers product registration (visa issuance), GMP / GPP / GDP / GLP licensing, controlled substances, pharmacovigilance and post-market surveillance. Statutory registration decisions are taken by the Director of DAV on the recommendation of the DAV Drug Advisory Council. Vietnam's National Centre of Drug Information and Adverse Drug Reactions Monitoring (DI&ADR Centre) administers pharmacovigilance.
Reliance & recognition
DAV recognises Stringent Regulatory Authority (SRA) approvals and WHO Prequalification under the reliance / reference-visa procedures introduced by Circular 08/2022/TT-BYT and refined by Circular 12/2025/TT-BYT. ASEAN harmonisation (ACTD/ACTR) supports cross-recognition within ASEAN.
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