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

The Ministry of Health has issued Decision 3044/QD-BYT, published by the Drug Administration of Vietnam. It announces four amended and supplemented administrative procedures for the registration of drugs and pharmaceutical starting materials under Circular 32/2026/TT-BYT of 29 July 2026. The four procedures cover granting, renewing, changing and withdrawing (at the holder's request) marketing authorisations. Under Article 2, the Decision takes effect on 1 October 2026 and repeals Decision 1983/QD-BYT of 16 June 2025, which had published the same procedures under the former Circular 12/2025/TT-BYT.

What the document is

Deputy Minister Do Xuan Tuyen signed the Decision on behalf of the Minister of Health, on the proposal of the Director General of the Drug Administration of Vietnam. It is an administrative-procedure publication. The substantive requirements come from Circular 32/2026/TT-BYT; the Decision sets them out as coded, standardised procedure records. All four procedures are central-level and handled by the Drug Administration of Vietnam.

The four procedures (Article 1, Part I)

• 1.013742 – Granting a marketing authorisation for a drug or starting material
• 1.013705 – Renewing a marketing authorisation
• 1.013738 – Changing or supplementing a marketing authorisation
• 1.013741 – Withdrawing a marketing authorisation at the request of the manufacturer or registration holder

For the grant procedure, the amended elements are: the sequence of steps, dossier composition and number of copies, processing times, results, forms, conditions and legal basis.

Key points of the new-registration procedure

• Dossiers are filed under Article 15 of Decree 118/2025/ND-CP. Filing can be in person, online or by public postal service. One complete set is required.
• The Drug Administration will accept a dossier before some documents are available: the CPP for new drugs, the CPP in the case under Article 22(2)(d) of Circular 32/2026/TT-BYT, and the documents under Article 27(5)(b). These must be supplied no later than the second supplementation round (Article 44(2)(a)).
• Dossiers fall into 10 cases. Cases 1–6 depend on product type (chemical drugs with reference-authority approval, generics, essential-oil products, herbal medicines, new drugs, vaccines, biologicals and others). Case 7 covers starting materials, and cases 8–10 cover contract manufacturing and technology transfer. Each case has its own administrative, quality, non-clinical and clinical requirements.
• Under Article 2(9) of Circular 32/2026/TT-BYT, the reference authorities are the EMA and the WHO-listed stringent regulatory authorities (SRAs): ICH members before 23 October 2015 (US FDA, EU national regulators, MHRA, PMDA); ICH observers (Swissmedic, Health Canada); and countries with mutual-recognition agreements (Australia, Iceland, Liechtenstein, Norway).
• CEPs: a CEP issued before 1 September 2023 must bear the stamp of the finished-product manufacturer or the registrant. A CEP issued from 1 September 2023 must be the electronic version with a valid EDQM e-signature, plus a letter of access from the CEP holder. Registrants must also submit their own EDQM database lookup, with the link, confirmed by the registrant.
• If the active ingredient already holds a Vietnamese marketing authorisation and is used exactly as approved, no quality documentation for that ingredient is needed. Two certificates of analysis are still required, one from the finished-product manufacturer and one from the ingredient manufacturer.
• Vaccines not approved by a reference authority need clinical safety and immunogenicity data from the target population in Vietnam.
• New chemical drugs, vaccines and biologicals (except probiotics) need a risk management plan on Form 03/TT.

Processing times and fees

• Standard drug applications: up to 12 months
• Applications using reliance on a reference authority's assessment: up to 9 months
• Contract-manufactured or technology-transfer drugs: up to 3 months if the original drug holds a valid Vietnamese authorisation; up to 9 months if it does not or the authorisation has expired
• New drugs against group A infectious diseases with a declared epidemic: up to 15 days
• Priority cases under Article 7(5) of the Law on Pharmacy, and starting materials: up to 6 months

The PDF sets out the time limit for each stage (triage, expert appraisal, post-appraisal handling, advisory Council meeting, issuance). Fees are VND 11,000,000 per drug and VND 5,500,000 per starting material. The result is a marketing authorisation on Form 6A/TT (Appendix IX of Circular 32/2026/TT-BYT), a written request for supplements, or a notice of the advisory Council's conclusion.

Who may register

Article 54 of the Law on Pharmacy, quoted in the Decision, allows two kinds of registrant: entities that manufacture, wholesale, export or import drugs or starting materials in Vietnam, and foreign pharmaceutical businesses with a representative office in Vietnam.

Effective date and transition

• Article 2 sets the effective date as 1 October 2026. This is earlier than the issue date in the metadata (5 October 2026) and the e-signature timestamp, and the number and date fields are blank in the extracted copy. The text does not explain the gap.
• Decision 1983/QD-BYT of 16 June 2025 is repealed.
• The Decision has no transitional provisions. How dossiers filed under Circular 12/2025/TT-BYT are handled depends on Circular 32/2026/TT-BYT, which this text does not reproduce.
• We had only the first part of the annex. Check the full PDF for the detailed renewal, change and withdrawal procedures.

What affected companies should do

• Reclassify pipeline dossiers into the 10 new cases and check each against its document list.
• Use the forms in Appendix IX of Circular 32/2026/TT-BYT: 01/TT, 03/TT, 4A/TT, 05/TT, 6A/TT, 09/TT, 10/TT and 11/TT.
• Check CEP issue dates and prepare the e-CEP, letter of access and EDQM lookup printout.
• Plan to supply any deferred CPP by the second supplementation round.
• Budget the fees and build timelines around the new processing times.

Sources

• Drug Administration of Vietnam – announcement page: https://dav.gov.vn/quyet-dinh-so-3044qd-byt-ve-viec-cong-bo-tthc-duoc-sua-doi-bo-sung-trong-linh-vuc-duoc-pham-thuoc-pham-vi-quan-ly-cua-bo-y-te-quy-dinh-tai-thong-tu-so-322026tt-byt-ngay-2972026-cua-bo-truong-bo-y-te-quy-dinh-viec-dang-ky-luu-hanh-thuoc-nllt-n5532.html
• Signed PDF: https://dav.gov.vn/upload_images/files/3044_QD_BYT%202026_signed.pdf