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Regulatory news & curated articles

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

Total articles: 10
All 10 Medicine 3 Supplement 1 Food 2 Medical device 0 Cosmetic 0 General 4
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9 articles. Showing 1–9.

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Medicine

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
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Ministry of Health publishes internal procurement handbook for drugs and medical supplies — Decision 1589/QĐ-BYT (3 June 2026)
General

Ministry of Health publishes internal procurement handbook for drugs and medical supplies — Decision 1589/QĐ-BYT (3 June 2026)

A 69-page operations manual aligned with Prime Minister's Directive 24/CT-TTg (29/7/2024), built on Luật Đấu thầu 22/2023/QH15 (as amended by Luật 57/2024 and Luật 90/2025), Nghị định 214/2025/NĐ-CP and Thông tư 40/2025/TT-BYT — covering procurement planning, open competitive tender, competitive offer, direct procurement and designation, for entities under the Ministry of Health.

#regulatory #procurement #dau-thau #mua-sam-cong #quyet-dinh-1589-2026 #bo-y-te #chi-thi-24-ct-ttg-2024 #luat-dau-thau-22-2023 #luat-57-2024 #luat-90-2025 #nghi-dinh-214-2025 #thong-tu-79-2025-btc #thong-tu-80-2025-btc #thong-tu-40-2025-byt #mua-sam-thuoc #mua-sam-hoa-chat #mua-sam-vat-tu-xet-nghiem #mua-sam-thiet-bi-y-te #e-hsmt
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General

Telemedicine in Vietnam — regulations and conditions, with a focus on foreign companies

Khám bệnh, chữa bệnh từ xa is no longer an exception scheme. From 1 January 2024, Luật 15/2023/QH15 codifies it as a regulated form of medical practice; Nghị định 96/2023/NĐ-CP and Thông tư 32/2023/TT-BYT pin the operational conditions; Quyết định 2628/QĐ-BYT remains the operational backbone of the inter-facility network; and a data / cybersecurity overlay — Nghị định 13/2023/NĐ-CP, Luật Giao dịch điện tử 2023, Nghị định 53/2022/NĐ-CP, Luật Bảo vệ dữ liệu cá nhân 2025 — applies on top. For a foreign company, the entry path is constrained at three layers: the WTO schedule and Luật Đầu tư 2020 (corporate vehicle), the practising licence and language rule for the doctor (Điều 21), and the data-localisation and consent regime (Nghị định 13/2023, Luật BVDLCN). A synthesis of the law text on Cổng thông tin Chính phủ and ThuVienPhapLuat, the implementing decree and circular, the 2020 telehealth project decision, and analytical coverage from kcb.vn, xaydungchinhsach.chinhphu.vn and LuatVietnam.

#regulatory #kham-chua-benh-tu-xa #telemedicine #luat-15-2023 #nghi-dinh-96-2023 #thong-tu-32-2023 #quyet-dinh-2628 #nghi-quyet-21-2026 #foreign-investment #luat-dau-tu-2020 #wto-commitments #du-lieu-ca-nhan #nghi-dinh-13-2023 #an-ninh-mang #giao-dich-dien-tu #ho-so-benh-an-dien-tu
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General

Universities training medicine and pharmacy in Vietnam — a 2026 map of history, faculties and students

From the École de Médecine de l'Indochine founded in Hanoi in 1902 to the ~35+ accredited universities and academies operating today, Vietnam's medical and pharmaceutical training system now spans the historic flagships, regional public universities, the Vietnam Military Medical University and a growing cluster of private schools led by VinUniversity. A synthesis read against Luật Khám bệnh, chữa bệnh 2023 (Luật 15/2023/QH15), Nghị định 96/2023/NĐ-CP, and the National Medical Licensing Exam phasing in from 1 January 2027.

#education #dao-tao-y-duoc #medical-education #pharmacy-education #hmu #ump #hup #hue-ump #ctump #vmmu #vinuni #nmle #hoi-dong-y-khoa-quoc-gia #luat-kcb-2023
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General

Conditions for medical practice in Vietnam — what businesses, hospitals/clinics and individual practitioners must meet under the 2024-2026 framework

From 1 January 2024, Luật Khám bệnh, chữa bệnh số 15/2023/QH15 replaced the 2009 law and rewrote the architecture of medical practice. Nghị định 96/2023/NĐ-CP and Thông tư 32/2023/TT-BYT detailed the new conditions for both individual practitioners (Giấy phép hành nghề) and establishments (Giấy phép hoạt động). From 1 January 2025 the three-tier system (cấp ban đầu / cấp cơ bản / cấp chuyên sâu) replaced the old four-tier scheme, and from 1 July 2026 Nghị quyết 21/2026/NQ-CP delegates practising licence authority from Bộ Y tế to Chủ tịch UBND cấp tỉnh. A synthesis of the law text on Cổng thông tin Chính phủ and ThuVienPhapLuat, the implementing decree and circular, the delegation resolution, and analysis from kcb.vn, xaydungchinhsach.chinhphu.vn and LuatVietnam.

#regulatory #kham-chua-benh #hanh-nghe-y-te #luat-15-2023 #nghi-dinh-96-2023 #thong-tu-32-2023 #nghi-quyet-21-2026 #giay-phep-hanh-nghe #giay-phep-hoat-dong #hoi-dong-y-khoa-quoc-gia #cap-chuyen-mon-ky-thuat
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Medicine

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
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Decree 46/2026 vs Decree 15/2018 — a structured comparison of Vietnam's food-safety reset
Food

Decree 46/2026 vs Decree 15/2018 — a structured comparison of Vietnam's food-safety reset

Eight years of regulatory practice under Decree 15/2018 have been replaced — section by section — by Decree 46/2026, in force from 15 April 2026 after a 75-day suspension. A deep, area-by-area comparison of what the new framework keeps, narrows, expands, and introduces for the first time.

#regulatory #food-safety #decree-46-2026 #decree-15-2018 #comparison #gmp #haccp
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Decree 46/2026/NĐ-CP — From customs-clearance crisis to a phased restart: where food-safety reform stands now
Food

Decree 46/2026/NĐ-CP — From customs-clearance crisis to a phased restart: where food-safety reform stands now

Signed 26 January 2026 to replace Decree 15/2018, the new food-safety decree triggered a multi-association revolt within ten days, was suspended by Resolution 09/2026/NQ-CP until 15 April 2026, and has now resumed with only partial guidance in place. A synthesis of reporting from VnEconomy, VietnamNet, NLD, baochinhphu.vn, LuatVietnam and the VIB business-impact survey.

#regulatory #food-safety #decree-46-2026 #decree-15-2018 #import #haccp
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