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Regulatory updates, official notices, and curated commentary — organised by section: medicines, supplements, foods, medical devices, and cosmetics.

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Medicine 2026-06-08

Circular 18/2026/TT-BYT — Ministry of Health overhauls the rules for narcotic, psychotropic, precursor and radioactive medicines

Signed 1 June 2026 by Deputy Minister Nguyễn Tri Thức and effective 16 July 2026, Circular 18/2026/TT-BYT replaces Thông tư 20/2017 and 27/2024 as the implementing instrument for the Pharmacy Law and Decree 163/2025/NĐ-CP. Five chapters, nineteen articles, and a same-day reclassification of Etomidate and Carisoprodol as psychotropic substances.

#regulatory #thuoc-kiem-soat-dac-biet #thong-tu-18-2026-byt #luat-duoc #nghi-dinh-163-2025 #thong-tu-20-2017-byt #thong-tu-27-2024-byt #gay-nghien #huong-than #tien-chat #thuoc-phong-xa #ho-so-dien-tu #etomidate #carisoprodol

Pharmacovigilance obligations of drug manufacturers in Vietnam — what changes under Luật 44/2024 and Circular 12/2025

From 1 July 2025, the amended Pharmacy Law (Luật 44/2024/QH15) and the new drug-registration circular (Thông tư 12/2025/TT-BYT) took effect together, reshaping the operational duties of marketing-authorisation holders, manufacturers, importers and distributors. The 2021 National Pharmacovigilance Guideline (Quyết định 122/QĐ-BYT) survives as the technical backbone. A synthesis of the consolidated Pharmacy Law (VBHN 39/VBHN-VPQH / 76/VBHN-VPQH), DAV guidance, and industry analysis from LuatVietnam, ThuVienPhapLuat, the canhgiacduoc.org.vn DI&ADR portal, Lexology and Dione.

#regulatory #pharmacovigilance #canh-giac-duoc #luat-duoc-44-2024 #thong-tu-12-2025 #adr #psur #risk-management-plan