Regulatory Affairs

This section is a Vietnam-focused reference for pharmaceutical regulation under the Ministry of Health (Bộ Y tế) and the Drug Administration of Vietnam (Cục Quản lý Dược — DAV). Scope: • Marketing authorization (giấy đăng ký lưu hành) for chemical drugs, biologicals, vaccines, and herbal medicines. • Technical dossier requirements in ACTD / ICH CTD format, and bioequivalence rules for generics. • GMP, GLP, GSP, GDP, and GPP certification for manufacturers, labs, warehouses, distributors, and community pharmacies. • Drug labelling, package inserts, and patient information leaflets. • Post-marketing obligations: variations, renewals, recalls. • Special pathways for orphan drugs, novel biologicals, and traditional medicines. Legal hierarchy in Vietnam: Law → Decree (Nghị định) → Circular (Thông tư). The Pharmacy Law sets the framework, government decrees implement it, and Ministry of Health circulars set technical detail. Companies operating in Vietnam should track DAV announcements and the official Gazette (Công báo).

Pharmacy Law: • Law on Pharmacy No. 105/2016/QH13 — the foundational law on pharmacy practice, drug registration, manufacture, and distribution; in force from 1 January 2017. • Law No. 44/2024/QH15 — amends and supplements articles of the Pharmacy Law; effective 1 July 2025. Key changes: streamlined renewal of marketing authorizations, expanded scope for online drug retail, and new provisions on drug pricing oversight. Decrees (Nghị định): • Decree 54/2017/NĐ-CP — guidance on implementing the Pharmacy Law. • Decree 155/2018/NĐ-CP — amends Decree 54; cuts business conditions and administrative procedures. Drug registration: • Circular 08/2022/TT-BYT — registration of pharmaceuticals and pharmaceutical starting materials; updates and supersedes parts of Circular 32/2018/TT-BYT. • Circular 32/2018/TT-BYT — registration of pharmaceuticals (original framework, partially superseded). GxP certification: • Circular 35/2018/TT-BYT — Good Manufacturing Practice (WHO-GMP, PIC/S-GMP, EU-GMP reference). • Circular 36/2018/TT-BYT — Good Storage Practice (GSP). • Circular 03/2018/TT-BYT — Good Distribution Practice (GDP). • Circular 02/2018/TT-BYT — Good Pharmacy Practice (GPP) for community pharmacies. Labelling: • Circular 01/2018/TT-BYT — drug labelling and patient information leaflets. Note: Circular numbers and effective dates should be verified against the official publication on the DAV portal or the Ministry of Health Gazette before relying on them for regulatory submissions.

2025 — Amended Pharmacy Law in force: Law 44/2024/QH15 took effect on 1 July 2025. The amendment streamlines marketing authorization renewals (extension of automatic validity in defined cases), formalizes online retail of non-prescription medicines under strict conditions, and tightens oversight of drug pricing declarations. 2024 — Backlog clearance on MA renewals: DAV continued the temporary extension mechanism for marketing authorizations whose renewal dossiers were pending, allowing affected products to remain on market while evaluation completes. 2022 — Circular 08/2022/TT-BYT: Updated registration framework introduced ACTD/ICH-CTD harmonization, clarified requirements for biosimilars, and revised timelines for evaluation. 2018–2019 — GxP modernization: Vietnam adopted PIC/S-GMP as a reference standard and progressively required upgrades for domestic manufacturers. Foreign manufacturers must hold an equivalent recognized GMP certificate (WHO-GMP, PIC/S-GMP, EU-GMP, or US-FDA).