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Traditional Medicine & Medicinal Materials in Vietnam

Registration, quality, cultivation (GACP), and retail of thuốc cổ truyền, vị thuốc cổ truyền and dược liệu — under Pharmacy Law Chapter VI as amended by Law 44/2024/QH15, the post-1 July 2025 stack (Decree 163/2025/NĐ-CP, Circulars 29/2025 + 32/2025 + 31/2025/TT-BYT), the GACP Circular 19/2019/TT-BYT, and the national 2030 programme under Decision 1893/QĐ-TTg.

Overview

Vietnamese traditional medicine sits in its own chapter of the Pharmacy Law and runs on its own circulars, separate from the modern-medicine track. The Pharmacy Law's Chương VI distinguishes three commercial product types: dược liệu (medicinal materials — raw plant, animal or mineral substances, now expressly including nấm / fungi after the Law 44/2024/QH15 amendment), vị thuốc cổ truyền (processed traditional medicinal substances; given a standalone legal definition by Law 44/2024), and thuốc cổ truyền (formulated traditional medicines). Modern finished pharmaceuticals register under Circular 12/2025/TT-BYT; the three traditional-side categories explicitly do not and instead run on Circular 29/2025/TT-BYT.

Scope of this page:

  • What the regime covers and how it differs from modern medicines.
  • The two-tier authority structure during 2025–2027 and the decentralisation milestone on 1 July 2027.
  • The post-1 July 2025 legal stack — Pharmacy Law Chương VI, Decree 163/2025/NĐ-CP, Circulars 29/2025, 32/2025 and 31/2025.
  • Registration of thuốc cổ truyền, vị thuốc cổ truyền and dược liệu under TT 29/2025.
  • Quality management under TT 32/2025, including the new "công bố tiêu chuẩn chất lượng" obligation.
  • GACP cultivation and collection standards under TT 19/2019 — still in force; mandatory by 1 January 2030.
  • Commercial activity — kinh doanh thuốc cổ truyền — including the dedicated retail format and the CCHND traditional-medicine practice scope.
  • The national 2030 programme under Decision 1893/QĐ-TTg.

Authority structure (2025–2027 and beyond):

  • Bộ Y tế leads the regime through the Cục Quản lý Y, Dược cổ truyền (Department of Traditional Medicine — a separate directorate from the Drug Administration of Vietnam / Cục Quản lý Dược which handles modern medicines). Through 30 June 2027, the Cục centrally issues, renews and revokes marketing authorisations for thuốc cổ truyền, vị thuốc cổ truyền and dược liệu.
  • Sở Y tế (provincial Department of Health) or the equivalent specialised health authority under the provincial People's Committee issues the GCN ĐĐKKDD for retail establishments and the CCHND for the dược cổ truyền practice scope.
  • From 1 July 2027, authority to issue, renew, vary or revoke marketing-authorisation for vị thuốc cổ truyền and dược liệu devolves to the provincial-level cơ quan chuyên môn về y tế thuộc UBND cấp tỉnh. The Cục Quản lý Y, Dược cổ truyền continues central authority for thuốc cổ truyền proper. This is the most consequential structural change in the regime since Luật 105/2016 itself; pre-2027 dossiers and the 2027-onwards regime differ in submission point even though the legal basis remains TT 29/2025.

Legal stack (current from 1 July 2025):

  • Pharmacy Law 105/2016/QH13, Chương VI — Mục 1 (Dược liệu: Articles 66 on cultivation, harvesting, collection and processing; 67 on storage; 68 on quality) and Mục 2 (Thuốc cổ truyền: Articles 69 on commercial activity; 70 on supply, compounding and use in healthcare facilities; 71 on marketing authorisation, circulation and recall; 72 on clinical trial before registration; 73 on quality).
  • Law 44/2024/QH15 amends Chương VI definitions: dược liệu expressly includes nấm (fungi); vị thuốc cổ truyền gains a standalone definition; conforming changes flow into Articles 66–73.
  • Decree 163/2025/NĐ-CP — implementing decree for the Pharmacy Law including the traditional-medicine chapter.
  • Circular 29/2025/TT-BYT — marketing-authorisation registration for thuốc cổ truyền, vị thuốc cổ truyền and dược liệu. Replaces Circular 21/2018/TT-BYT and its amendments TT 39/2021/TT-BYT and TT 54/2024/TT-BYT.
  • Circular 32/2025/TT-BYT — quality management for thuốc cổ truyền, vị thuốc cổ truyền and dược liệu. Effectively replaces Circular 13/2018/TT-BYT for all overlapping provisions.
  • Circular 31/2025/TT-BYT — implementing detail for Decree 163/2025, including the CCHND application procedure with a dedicated dược cổ truyền scope.
  • Circular 19/2019/TT-BYT — GACP for cultivation and collection. Not affected by Circular 11/2025 (which only amended GPP, GDP, GSP). Mandatory deadline 1 January 2030; GACP certificate validity is 3 years.
  • Decision 2238/QĐ-BYT (5 July 2025) publishes seven new administrative procedures and abolishes thirteen prior procedures in the Y, Dược cổ truyền field, aligning practice with TT 29/2025 and TT 32/2025.

Registration of thuốc cổ truyền, vị thuốc cổ truyền and dược liệu (Circular 29/2025/TT-BYT): A marketing authorisation under the traditional-medicine track is required before any of the three product types may be commercialised in Vietnam — manufactured, imported, distributed or reimbursed by Vietnam Social Security. The instrument explicitly sets a separate dossier and evaluation pathway from Circular 12/2025/TT-BYT (which handles modern medicines and starting materials and explicitly excludes traditional categories). Dossier composition follows Decree 163/2025 and TT 29/2025; registration validity period . Importation of dược liệu is subject to additional quality control and traceability rules under TT 32/2025.

Quality management (Circular 32/2025/TT-BYT): TT 32/2025 introduces the central operational obligation of the new regime: from 1 July 2025, any vị thuốc cổ truyền or dược liệu put into circulation must first have its quality standard publicly declared (công bố tiêu chuẩn chất lượng) by the responsible establishment. The published Bộ Y tế list of declared materials is maintained on the Cục Quản lý Y, Dược cổ truyền portal. Establishments are responsible for the conformity of every batch against the declared standard; provincial Sở Y tế units and the Cục audit conformity on inspection. Thuốc cổ truyền proper continues to operate under the marketing-authorisation quality controls of the registration dossier.

Good Agricultural and Collection Practices for medicinal plants (Circular 19/2019/TT-BYT): GACP — implemented in Vietnam as a unified standard aligned with GACP-WHO — covers cultivation, harvesting and wild-collection of medicinal plants and the production of medicinal materials. A GACP certificate is valid for three years and is required before an establishment may sell its output as compliant medicinal material to the regulated supply chain. The transition window has a fixed mandatory deadline: from 1 January 2030 onwards every cultivation and wild-collection facility supplying the formal sector must hold a current GACP certificate. Circular 11/2025 (which amended GPP, GDP and GSP) did not touch GACP.

Commercial activity and personnel: Establishments engaged in any form of trading dược liệu, vị thuốc cổ truyền or thuốc cổ truyền must hold the umbrella Giấy chứng nhận đủ điều kiện kinh doanh dược (GCN ĐĐKKDD) for the relevant form of pharmacy business — manufacture, import-export, wholesale, storage services, or retail. See the Medibase Distribution & Retail page for the umbrella framework. Retail specifically uses the dedicated format under Article 32.2.d of the Pharmacy Law: "cơ sở chuyên bán lẻ dược liệu, thuốc dược liệu, thuốc cổ truyền". The responsible person must hold a Chứng chỉ hành nghề dược (CCHND) with the dược cổ truyền practice scope under Decree 163/2025 and Circular 31/2025.

Cross-cutting concerns:

  • Some traditional substances yield alkaloids (such as morphine and codeine from opium poppy) that are subject to the special-control regime as narcotic or psychotropic substances. Trade in these crosses both this page and the Medibase Special-Control Medicines page; the special-control overlay prevails on storage, records and reporting.
  • Imported dược liệu must additionally clear customs and phytosanitary controls under the Ministry of Agriculture and Rural Development's plant-protection regime.
  • Pharmacovigilance applies equally to thuốc cổ truyền — adverse reactions must be reported to the National Centre.

National 2030 programme: Decision 1893/QĐ-TTg, signed by the Prime Minister on 25 December 2019, establishes the national programme "Chương trình phát triển y dược cổ truyền, kết hợp y dược cổ truyền với y dược hiện đại đến năm 2030" — the development of traditional Vietnamese pharmacy and its integration with modern medicine through 2030. Headline targets: traditional medicine to reach at least 20 % share of Vietnam Social Security drug reimbursement by 2025 and at least 30 % by 2030; locally cultivated dược liệu to supply at least 5 % of the traditional-medicine input chain. The 2025 "sơ kết" (interim review) milestone has passed; no superseding national strategy has been promulgated as of June 2026.

Key documents

Pharmacy Law and amendments:

  • Pharmacy Law 105/2016/QH13 — passed 6 April 2016, in force 1 January 2017. Chương VI (Articles 66–73) covers dược liệu, vị thuốc cổ truyền and thuốc cổ truyền.
  • Law 44/2024/QH15 — passed 21 November 2024, effective 1 July 2025. Amends Chương VI to include nấm in dược liệu and introduces a separate definition for vị thuốc cổ truyền.

Implementing decree:

  • Decree 163/2025/NĐ-CP — issued 29 June 2025, effective 1 July 2025. Implements the Pharmacy Law including the traditional-medicine chapter.

Circulars (post-1 July 2025 — current):

  • Circular 29/2025/TT-BYT — marketing-authorisation registration for thuốc cổ truyền, vị thuốc cổ truyền and dược liệu. Replaces Circular 21/2018/TT-BYT and its amendments TT 39/2021 and TT 54/2024.
  • Circular 32/2025/TT-BYT — quality management for thuốc cổ truyền, vị thuốc cổ truyền and dược liệu. Introduces the "công bố tiêu chuẩn chất lượng" obligation. Replaces Circular 13/2018/TT-BYT.
  • Circular 31/2025/TT-BYT — implementing detail for Decree 163/2025; includes the CCHND application procedure with the dược cổ truyền practice scope.
  • Circular 19/2019/TT-BYT — GACP for cultivation and collection of medicinal plants. Still in force unchanged; mandatory deadline 1 January 2030; certificate validity 3 years.

Decisions:

  • Decision 1893/QĐ-TTg — Prime Minister, 25 December 2019. National Programme on the Development of Traditional Pharmacy and its Integration with Modern Medicine to 2030.
  • Decision 2238/QĐ-BYT — Minister of Health, 5 July 2025. Publishes seven new and abolishes thirteen prior administrative procedures in the Y, Dược cổ truyền field.

Adjacent (cross-cutting):

  • Circular 12/2025/TT-BYT — modern-medicine registration; explicitly excludes thuốc cổ truyền, vị thuốc cổ truyền and dược liệu.
  • Circular 18/2026/TT-BYT — special-control medicines. Relevant where dược liệu yields narcotic, psychotropic or precursor substances. See the Medibase Special-Control Medicines page.
  • Pharmacy retail / wholesale umbrella — see the Medibase Distribution & Retail page.

Source documents

Direct links to the official text on government portals.

Primary law:

Decree:

Traditional-medicine Circulars (current):

Predecessors (superseded since 1 July 2025):

  • Circular 21/2018/TT-BYT — see thuvienphapluat.vn search.
  • Circular 13/2018/TT-BYT — see thuvienphapluat.vn search.
  • Circular 39/2021/TT-BYT and Circular 54/2024/TT-BYT — see thuvienphapluat.vn search.

Decisions:

Cross-reference:

Recent updates

21 November 2024 — National Assembly passes Law 44/2024/QH15 amending the Pharmacy Law, including the Chương VI definitions of dược liệu (now expressly including nấm) and vị thuốc cổ truyền (standalone definition).

29 June 2025 — Government issues Decree 163/2025/NĐ-CP.

1 July 2025 — Simultaneous effective date: amended Pharmacy Law, Decree 163/2025, Circular 29/2025/TT-BYT (registration of traditional medicines), Circular 32/2025/TT-BYT (quality, with the new công bố tiêu chuẩn chất lượng obligation), and Circular 31/2025/TT-BYT (CCHND including dược cổ truyền scope).

5 July 2025 — Minister of Health issues Decision 2238/QĐ-BYT publishing seven new administrative procedures and abolishing thirteen prior procedures in the Y, Dược cổ truyền field.

Late 2025 — Cục Quản lý Y, Dược cổ truyền begins publishing the consolidated list of dược liệu with declared quality standards under TT 32/2025 (first batch published 12 November 2025).

Upcoming — 1 July 2027: marketing-authorisation authority for vị thuốc cổ truyền and dược liệu devolves from the central Cục Quản lý Y, Dược cổ truyền to provincial-level specialised health authorities. Thuốc cổ truyền proper remains centrally administered.

Upcoming — 1 January 2030: GACP becomes mandatory for every cultivation and wild-collection facility supplying the formal sector under Circular 19/2019/TT-BYT.

Resources & links

Operational portals:

  • Cục Quản lý Y, Dược cổ truyền (Department of Traditional Medicine, Bộ Y tế) — https://ydct.moh.gov.vn — main agency site; circulars, decisions and the public list of declared dược liệu quality standards under TT 32/2025.
  • Drug Administration of Vietnam (DAV) — https://dav.gov.vn — umbrella regulator; for the modern-medicine track and the pharmacy business framework.
  • Sở Y tế (provincial Department of Health) — application portal for retail GCN ĐĐKKDD and CCHND; e.g. Sở Y tế Hà Nội (https://soyte.hanoi.gov.vn), Sở Y tế TP. HCM (https://medinet.gov.vn).

Legal text portals:

  • Cổng thông tin điện tử Chính phủ — văn bản pháp luật — https://vanban.chinhphu.vn — primary publisher of laws and decrees.
  • Công báo điện tử — https://congbao.chinhphu.vn — Official Gazette.
  • Thư viện pháp luật — https://thuvienphapluat.vn — searchable archive with selected English working translations.
  • Cổng pháp luật quốc gia (Bộ Tư pháp) — https://vbpl.vn — official national legal database; Ministry of Health subset at https://vbpl.vn/boyte.

Reference and standards:

  • National Institute of Medicinal Materials (NIMM, Viện Dược liệu) — https://www.vienduoclieu.org.vn — research and standards reference for dược liệu.
  • Vietnamese Pharmacopoeia (Dược điển Việt Nam) — published by the Hội đồng Dược điển; contains official monographs for dược liệu and vị thuốc cổ truyền.

Medibase cross-references:

  • Reference — Distribution & Retail — /medicine/distribution-retail/
  • Reference — Special-Control Medicines — /medicine/special-control/
  • Reference — Drug Registration Process (modern medicines) — /medicine/registration/

Frequently asked questions

What is the difference between thuốc cổ truyền, vị thuốc cổ truyền and dược liệu?

Dược liệu are raw medicinal materials of plant, animal or mineral origin — including nấm (fungi) after Law 44/2024. Vị thuốc cổ truyền are processed traditional medicinal substances (given a standalone legal definition by Law 44/2024). Thuốc cổ truyền are formulated traditional medicines — the finished product. All three register and operate under the traditional-medicine track (Circular 29/2025 + 32/2025), distinct from the modern-medicine track (Circular 12/2025).

Who issues marketing authorisation for traditional medicines?

From 1 July 2025 through 30 June 2027, the Cục Quản lý Y, Dược cổ truyền (Department of Traditional Medicine, Bộ Y tế) is the central issuing authority for all three product types — thuốc cổ truyền, vị thuốc cổ truyền and dược liệu. From 1 July 2027 onwards, authority for vị thuốc cổ truyền and dược liệu devolves to provincial-level specialised health authorities; the Cục retains central authority for thuốc cổ truyền proper.

What changes on 1 July 2027?

Marketing-authorisation authority for vị thuốc cổ truyền and dược liệu — the two raw / processed-substance categories — devolves from the central Cục Quản lý Y, Dược cổ truyền to provincial-level cơ quan chuyên môn về y tế thuộc UBND cấp tỉnh. The legal basis remains Circular 29/2025/TT-BYT, but the submission point shifts. Thuốc cổ truyền (formulated finished medicines) continue to be centrally administered. This is the most consequential structural change in the regime since Law 105/2016 itself.

Is GACP mandatory for cultivation and wild-collection of medicinal plants?

Yes, from 1 January 2030. Circular 19/2019/TT-BYT (still in force unchanged) sets a fixed mandatory deadline: from that date, every cultivation and wild-collection facility supplying the formal sector must hold a current GACP certificate. The certificate is valid for three years. Circular 11/2025 (which amended GPP, GDP and GSP) did not touch GACP.

What does the national 2030 programme aim for?

Decision 1893/QĐ-TTg (Prime Minister, 25 December 2019) sets the framework programme to develop traditional Vietnamese medicine and integrate it with modern medicine through 2030. Headline targets: traditional medicines to reach at least 20 % share of Vietnam Social Security drug reimbursement by 2025 and at least 30 % by 2030; locally cultivated dược liệu to supply at least 5 % of the traditional-medicine input chain. The 2025 interim review milestone has passed; no superseding national strategy has been promulgated.

Page changelog

2026-06-28: Initial publication. Reflects amended Pharmacy Law 44/2024/QH15 (Chương VI), Decree 163/2025/NĐ-CP, Circular 29/2025/TT-BYT (registration), Circular 32/2025/TT-BYT (quality, with the new công bố tiêu chuẩn chất lượng obligation), Circular 31/2025/TT-BYT (CCHND including dược cổ truyền scope), GACP Circular 19/2019/TT-BYT (mandatory 1 January 2030), and Decision 1893/QĐ-TTg (national 2030 programme).

Effective from:
2025-07-01
Last reviewed:
2026-06-28
Page updated:
2026-06-28

Reference information only; not legal or medical advice.