Traditional Medicine & Medicinal Materials in Vietnam

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 Chapter VI distinguishes three commercial product types: medicinal materials (raw plant, animal or mineral substances, now expressly including fungi after the Law 44/2024/QH15 amendment), processed traditional medicinal ingredients (processed traditional medicinal substances; given a standalone legal definition by Law 44/2024), and traditional medicines (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 Chapter VI, Decree 163/2025/ND-CP, Circulars 29/2025, 32/2025 and 31/2025.
• Registration of traditional medicines, processed traditional medicinal ingredients and medicinal materials under Circular 29/2025.
• Quality management under Circular 32/2025, including the new quality-standard declaration obligation.
• GACP cultivation and collection standards under Circular 19/2019 — still in force; mandatory by 1 January 2030.
• Commercial activity — trading in traditional medicines — including the dedicated retail format and the traditional-medicine practice scope of the pharmacy practising certificate.
• The national 2030 programme under Decision 1893/QD-TTg.

Authority structure (2025–2027 and beyond):

• Ministry of Health leads the regime through the Traditional Medicine Administration (a separate directorate from the Drug Administration of Vietnam, which handles modern medicines). Through 30 June 2027, the Administration centrally issues, renews and revokes marketing authorisations for traditional medicines, processed traditional medicinal ingredients and medicinal materials.
• provincial Department of Health or the equivalent specialised health authority under the provincial People's Committee issues the Pharmacy Business Eligibility Certificate for retail establishments and the pharmacy practising certificate for the traditional-pharmacy practice scope.
• From 1 July 2027, authority to issue, renew, vary or revoke marketing-authorisation for processed traditional medicinal ingredients and medicinal materials devolves to the specialised health agencies under the provincial People's Committees. The Traditional Medicine Administration continues central authority for traditional medicines proper. This is the most consequential structural change in the regime since Law 105/2016 itself; pre-2027 dossiers and the 2027-onwards regime differ in submission point even though the legal basis remains Circular 29/2025.

Legal stack (current from 1 July 2025):

• Pharmacy Law 105/2016/QH13, Chapter VI — Section 1 (Medicinal materials: Articles 66 on cultivation, harvesting, collection and processing; 67 on storage; 68 on quality) and Section 2 (Traditional medicines: 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 Chapter VI definitions: medicinal materials expressly includes fungi; processed traditional medicinal ingredients gains a standalone definition; conforming changes flow into Articles 66–73.
• Decree 163/2025/ND-CP — implementing decree for the Pharmacy Law including the traditional-medicine chapter.
• Circular 29/2025/TT-BYT — marketing-authorisation registration for traditional medicines, processed traditional medicinal ingredients and medicinal materials. Replaces Circular 21/2018/TT-BYT and its amendments Circular 39/2021/TT-BYT and Circular 54/2024/TT-BYT.
• Circular 32/2025/TT-BYT — quality management for traditional medicines, processed traditional medicinal ingredients and medicinal materials. Effectively replaces Circular 13/2018/TT-BYT for all overlapping provisions.
• Circular 31/2025/TT-BYT — implementing detail for Decree 163/2025, including the application procedure for the pharmacy practising certificate with a dedicated traditional-pharmacy 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/QD-BYT (5 July 2025) publishes seven new administrative procedures and abolishes thirteen prior procedures in the traditional medicine and pharmacy field, aligning practice with Circular 29/2025 and Circular 32/2025.

Registration of traditional medicines, processed traditional medicinal ingredients and medicinal materials (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 Circular 29/2025; registration validity period . Importation of medicinal materials is subject to additional quality control and traceability rules under Circular 32/2025.

Quality management (Circular 32/2025/TT-BYT): Circular 32/2025 introduces the central operational obligation of the new regime: from 1 July 2025, any processed traditional medicinal ingredients or medicinal materials put into circulation must first have its quality standard publicly declared by the responsible establishment. The published Ministry of Health list of declared materials is maintained on the Traditional Medicine Administration portal. Establishments are responsible for the conformity of every batch against the declared standard; provincial Department of Health units and the Administration audit conformity on inspection. Traditional medicines 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 medicinal materials, processed traditional medicinal ingredients or traditional medicines must hold the umbrella Pharmacy Business Eligibility Certificate 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: "establishment specialising in the retail of medicinal materials, herbal medicines and traditional medicines". The responsible person must hold a pharmacy practising certificate with the traditional-pharmacy 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 medicinal materials must additionally clear customs and phytosanitary controls under the Ministry of Agriculture and Rural Development's plant-protection regime.
• Pharmacovigilance applies equally to traditional medicines — adverse reactions must be reported to the National Centre.

National 2030 programme: Decision 1893/QD-TTg, signed by the Prime Minister on 25 December 2019, establishes the national "Programme for the development of traditional medicine and pharmacy and its integration with modern medicine and pharmacy to 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 medicinal materials 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 as of June 2026.

Pharmacy Law and amendments:

• Pharmacy Law 105/2016/QH13 — passed 6 April 2016, in force 1 January 2017. Chapter VI (Articles 66–73) covers medicinal materials, processed traditional medicinal ingredients and traditional medicines.
• Law 44/2024/QH15 — passed 21 November 2024, effective 1 July 2025. Amends Chapter VI to include fungi in medicinal materials and introduces a separate definition for processed traditional medicinal ingredients.

Implementing decree:

• Decree 163/2025/ND-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 traditional medicines, processed traditional medicinal ingredients and medicinal materials. Replaces Circular 21/2018/TT-BYT and its amendments Circular 39/2021 and Circular 54/2024.
• Circular 32/2025/TT-BYT — quality management for traditional medicines, processed traditional medicinal ingredients and medicinal materials. Introduces the quality-standard declaration obligation. Replaces Circular 13/2018/TT-BYT.
• Circular 31/2025/TT-BYT — implementing detail for Decree 163/2025; includes the application procedure for the pharmacy practising certificate with the traditional-pharmacy 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/QD-TTg — Prime Minister, 25 December 2019. National Programme on the Development of Traditional Pharmacy and its Integration with Modern Medicine to 2030.
• Decision 2238/QD-BYT — Minister of Health, 5 July 2025. Publishes seven new and abolishes thirteen prior administrative procedures in the traditional medicine and pharmacy field.

Adjacent (cross-cutting):

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

Primary law:

• Pharmacy Law 105/2016/QH13 — https://vanban.chinhphu.vn/?pageid=27160&docid=184569
• Law 44/2024/QH15 — https://vanban.chinhphu.vn/?pageid=27160&docid=212466

Decree:

• Decree 163/2025/ND-CP — https://vanban.chinhphu.vn/?pageid=27160&docid=214322

Traditional-medicine Circulars (current):

• Circular 29/2025/TT-BYT (registration) — https://thuvienphapluat.vn/van-ban/The-thao-Y-te/Thong-tu-29-2025-TT-BYT-dang-ky-luu-hanh-thuoc-co-truyen-vi-thuoc-co-truyen-duoc-lieu-663448.aspx
• Circular 32/2025/TT-BYT (quality) — https://vanban.chinhphu.vn/?pageid=27160&docid=214395
• Circular 31/2025/TT-BYT (CCHND and Decree 163/2025 detail) — https://thuvienphapluat.vn/van-ban/The-thao-Y-te/Thong-tu-31-2025-TT-BYT-huong-dan-Luat-Duoc-Nghi-dinh-163-2025-ND-CP-663613.aspx
• Circular 19/2019/TT-BYT (GACP) — https://vbpl.vn/boyte/Pages/vbpq-toanvan.aspx?ItemID=138051

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:

• Decision 1893/QD-TTg (Programme to 2030) — https://thuvienphapluat.vn/van-ban/The-thao-Y-te/Quyet-dinh-1893-QD-TTg-2019-phat-trien-y-duoc-co-truyen-431740.aspx
• Decision 2238/QD-BYT (administrative procedures) — see Ministry of Health / Traditional Medicine Administration portal.

Cross-reference:

• List of medicinal materials with declared quality standards under Circular 32/2025 — https://ydct.moh.gov.vn/detail/danh-muc-cac-duoc-lieu-cong-bo-tieu-chuan-chat-luong-theo-thong-tu-so-32-2025-tt-byt-ngay-01-7-2025-ngay-cong-bo-12-11-2025
• Medibase reference — Distribution & Retail — https://medibase.vn/medicine/distribution-retail/
• Medibase reference — Special-Control Medicines — https://medibase.vn/medicine/special-control/

21 November 2024 — National Assembly passes Law 44/2024/QH15 amending the Pharmacy Law, including the Chapter VI definitions of medicinal materials (now expressly including fungi) and processed traditional medicinal ingredients (standalone definition).

29 June 2025 — Government issues Decree 163/2025/ND-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 quality-standard declaration obligation), and Circular 31/2025/TT-BYT (pharmacy practising certificate including traditional-pharmacy scope).

5 July 2025 — Minister of Health issues Decision 2238/QD-BYT publishing seven new administrative procedures and abolishing thirteen prior procedures in the traditional medicine and pharmacy field.

Late 2025 — Traditional Medicine Administration begins publishing the consolidated list of medicinal materials with declared quality standards under Circular 32/2025 (first batch published 12 November 2025).

Upcoming — 1 July 2027: marketing-authorisation authority for processed traditional medicinal ingredients and medicinal materials devolves from the central Traditional Medicine Administration to provincial-level specialised health authorities. Traditional medicines 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.