News & articles — Medibase

Medicine 2026-08-16

Circular 32/2026/TT-BYT — new drug-registration framework from 1 October 2026

Issued 29 July 2026 by the Ministry of Health, Circular 32/2026/TT-BYT replaces Circular 12/2025/TT-BYT as the operating rulebook for marketing-authorisation of chemical drugs, vaccines, biologicals, herbal medicines and pharmaceutical materials. Traditional medicine stays under Circular 29/2025. What actually changes, transitional provisions for in-flight dossiers, and what MA holders should do in the next six weeks.

#regulatory #drug-registration #circular-32-2026 #circular-12-2025 #marketing-authorisation

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Medicine 2026-06-08

Circular 18/2026/TT-BYT — special-control drugs

Signed 1 June 2026 by Deputy Minister Nguyen Tri Thuc and effective 16 July 2026, Circular 18/2026/TT-BYT replaces Circular 20/2017 and 27/2024 as the implementing instrument for the Pharmacy Law and Decree 163/2025/ND-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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General 2026-06-07

MOH procurement handbook — Decision 1589 (2026)

A 69-page operations manual aligned with Prime Minister's Directive 24/CT-TTg (29/7/2024), built on Law on Bidding 22/2023/QH15 (as amended by Law 57/2024 and Law 90/2025), Decree 214/2025/ND-CP and Circular 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 2026-05-20

Telemedicine Vietnam 2026 — foreign-firm rules

Telemedicine is no longer an exception scheme. From 1 January 2024, Law 15/2023/QH15 codifies it as a regulated form of medical practice; Decree 96/2023/ND-CP and Circular 32/2023/TT-BYT pin the operational conditions; Decision 2628/QD-BYT remains the operational backbone of the inter-facility network; and a data / cybersecurity overlay — Decree 13/2023/ND-CP, Law on Electronic Transactions 2023, Decree 53/2022/ND-CP, Personal Data Protection Law 2025 — applies on top. For a foreign company, the entry path is constrained at three layers: the WTO schedule and Law on Investment 2020 (corporate vehicle), the practising licence and language rule for the doctor, and the data-localisation and consent regime (Decree 13/2023, Personal Data Protection Law). A synthesis of the law text on the Government Portal 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 2026-05-19

Vietnam medical practice conditions 2024–2026

From 1 January 2024, the Law on Medical Examination and Treatment No. 15/2023/QH15 replaced the 2009 law and rewrote the architecture of medical practice. Decree 96/2023/ND-CP and Circular 32/2023/TT-BYT detailed the new conditions for both individual practitioners and establishments. From 1 January 2025 the three-tier system (initial / basic / specialised) replaced the old four-tier scheme, and from 1 July 2026 Resolution 21/2026/NQ-CP delegates practising licence authority from the Ministry of Health to the chairpersons of provincial People's Committees. A synthesis of the law text on the Government Portal 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 2026-05-19

Manufacturer pharmacovigilance duties (VN 2025–26)

From 1 July 2025, the amended Pharmacy Law (Law 44/2024/QH15) and the new drug-registration circular (Circular 12/2025/TT-BYT) took effect together, reshaping the operational duties of marketing-authorisation holders, manufacturers, importers and distributors. The 2021 National Pharmacovigilance Guideline (Decision 122/QD-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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Food 2026-05-16

Decree 46/2026 vs 15/2018 — food-safety compared

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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Food 2026-05-16

Decree 46/2026 — food-safety phased restart

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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Supplement 2026-05-06

Health-supplement ads → provincial People's Committees from 1 July 2026

Resolution 21/2026/NQ-CP decentralises Decree 15/2018 advertising approval from VFA to 63 provincial People's Committees, aiming to simplify dossiers; the Ministry of Health retains post-approval surveillance.

#regulatory #advertising #vfa #decree-15-2018

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