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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: 19
All 19 Medicine 11 Supplement 1 Food 3 Medical device 0 Cosmetic 0 General 4
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11 articles. Showing 1–11.

Official Letter 3656/QLD-KD: drug businesses must register on the national Pharmaceutical Database System (4 October 2026 deadline has passed)
Medicine

Official Letter 3656/QLD-KD: drug businesses must register on the national Pharmaceutical Database System (4 October 2026 deadline has passed)

The Drug Administration of Vietnam asks manufacturers, exporters, importers and storage-service providers of drugs and drug materials to register at csdlduoc.com.vn and connect their data, while provincial Departments of Health onboard wholesalers and pharmacies. The deadline was 4 October 2026; facilities not yet registered should do so now.

Draft amendments to Pharmacy Law Decree 163/2025/ND-CP: consultation closed on 2 November 2026
Medicine

Draft amendments to Pharmacy Law Decree 163/2025/ND-CP: consultation closed on 2 November 2026

Official Letter 8000/BYT-QLD circulated the draft Decree amending Decree 163/2025/ND-CP to ministries, business associations and pharmaceutical companies. The comment period ended on 2 November 2026. The Ministry of Health will now consolidate comments and finalise the draft for appraisal and submission to the Government; no issue date has been announced.

Ministry of Health revokes four Pharmacy Business Eligibility Certificates at the companies' request (28 Oct – 5 Nov 2026)
Medicine

Ministry of Health revokes four Pharmacy Business Eligibility Certificates at the companies' request (28 Oct – 5 Nov 2026)

Decisions 3304, 3307, 3332 and 3410/QD-BYT withdraw the certificates of CPC1 – Ho Chi Minh City Branch, Hoa Duoc Viet Nam, Medochemie (Vien Dong) and Cuu Ton Pharmaceutical. All four were requested by the companies themselves; no violations are cited.

Decision 3044/QD-BYT: Ministry of Health publishes four amended drug registration procedures under Circular 32/2026
Medicine

Decision 3044/QD-BYT: Ministry of Health publishes four amended drug registration procedures under Circular 32/2026

The Ministry of Health has republished the procedures for granting, renewing, changing and withdrawing marketing authorisations for drugs and pharmaceutical starting materials under Circular 32/2026/TT-BYT. Decision 1983/QD-BYT, issued under the former Circular 12/2025/TT-BYT, is repealed.

Draft law amending six laws goes to the National Assembly: drug wholesale prices, medical-device price controls
Medicine

Draft law amending six laws goes to the National Assembly: drug wholesale prices, medical-device price controls

On 21 October 2026 the Minister of Health presented a bill amending the Pharmacy Law, the Law on Medical Examination and Treatment, the Law on Health Insurance and three social laws. Drug companies would publish expected wholesale prices with their pricing method; medical-device businesses would list and declare prices on a national data system, managed across the product lifecycle. The bill is still under debate — no vote or effective date has been announced.

Search DAV declared & tender drug prices on Medibase — updated 2026-08-10
Medicine

Search DAV declared & tender drug prices on Medibase — updated 2026-08-10

Medibase now mirrors the public dataset published by Vietnam's Drug Administration (DAV) at dichvucong.dav.gov.vn/congbogiathuoc and adds cross-field indexed search on top. Look up declared wholesale prices or hospital tender-winning prices by active ingredient, registration number, manufacturer or country of origin — with the latest sync date and record count shown on every query.

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

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.

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

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.

Manufacturer pharmacovigilance duties (VN 2025–26)
Medicine

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.