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

Editorial note — text status: Circular 32/2026/TT-BYT was signed on 29 July 2026 by the Minister of Health and is scheduled to take effect on 1 October 2026. As of the publication date of this article (16 August 2026), the consolidated official text has not yet been indexed on vanban.chinhphu.vn or the official gazette (Công báo). The analysis below is compiled from the working text circulated through regulatory-affairs channels, verified against secondary summaries published by ALIAT (legal update), Mondaq (Tilleke & Gibbins commentary), LuatVietnam and Thư Viện Pháp Luật, and cross-checked against the operative Circular 12/2025 that it replaces. Where a specific article number is not yet confirmed against the official gazette, the description is qualified. This page will be updated once the DAV implementation notice and the consolidated official text are published.

What Circular 32/2026 does — the one-paragraph summary

Circular 32/2026/TT-BYT replaces Circular 12/2025/TT-BYT (issued 16 May 2025, effective 1 July 2025) as the operating rulebook for how the Drug Administration of Vietnam (DAV) accepts, reviews and grants marketing authorisations (giấy đăng ký lưu hành thuốc) for finished pharmaceuticals and pharmaceutical starting materials. Its declared scope covers chemical drugs, vaccines, biologicals, herbal drugs (thuốc dược liệu) and drug substances. Traditional medicine (thuốc cổ truyền) is not in scope of 32/2026 and continues under Circular 29/2025/TT-BYT — a boundary that matters for herbal-plus-traditional combination products.

1) Consolidated applications — one dossier, multiple products

Under Circular 12/2025 an MA application generally covered a single product line. Circular 32/2026 introduces a consolidated-application mechanism for multiple products that meet prescribed criteria — same active ingredient family, related packaging configurations, and equivalent batch-release arrangements can be filed in a single dossier. For a portfolio holder submitting a family of strengths or presentations of the same active substance, this can substantially reduce parallel-track processing overhead. The exact criteria (how many strengths, which presentation types) will be pinned down in the DAV implementation notice expected before 1 October.

2) Deferred CPP submission

The Certificate of a Pharmaceutical Product (CPP), issued by the exporting country's regulator on the WHO model form, has historically been a gating document at initial submission. Circular 32/2026 permits an applicant to submit the initial dossier without a CPP, provided a written justification is included and the CPP is filed by the second supplementation round. In practice this means an applicant can start Vietnam evaluation in parallel with the CPP application in the country of origin — cutting weeks or months from the critical path for products with recent SRA approval where the CPP is administratively delayed.

3) Simplified foreign-document authentication

Consular legalisation (hợp pháp hoá lãnh sự) has been the single most common Step 2 completeness failure for non-SRA dossiers. Circular 32/2026 introduces two structural fixes:

• Electronic verification: where the DAV can verify a foreign document electronically — either through direct official correspondence between agencies, or through a publicly accessible English-language regulatory database — consular legalisation is not required.
• Electronic notarised copies: where a paper document was required, electronic notarised copies now substitute for the hard-copy original in the dossier.

The Hague Apostille Convention comes into force for Vietnam on 11 September 2026 (three weeks before Circular 32), further simplifying documents from other signatories. Together these changes remove a large slice of the traditional bottleneck between the applicant's regulatory-affairs team and DAV completeness review.

4) Data exclusivity — 5 years, with mandatory publication

Circular 32/2026 explicitly codifies a 5-year data exclusivity period for new drugs (thuốc mới), starting from the initial marketing-authorisation approval date. During this window, subsequent applicants cannot rely on the originator's non-public clinical or preclinical data. To make the mechanism effective, DAV is required to publish subsequent applications five months before granting approval, giving the originator an opportunity to raise infringement objections. The 5-year window is a floor set by the circular; specific product classes may attract longer periods under Circular 05/2010/TT-BYT provisions carried forward.

5) Post-approval variations — 11 categories become 13

The minor-notification (MiV-N) framework expands from 11 to 13 categories. Two of the three additions map to changes MA holders have long treated as ambiguous:

• MiV-N11 — minor manufacturing-process changes meeting FDA SUPAC Level 1 criteria (the least-risk tier of the FDA's Scale-Up and Post-Approval Changes guidance). Previously many such changes were routed as MiV-N or MaV variations depending on evaluator interpretation.
• MiV-N12 — changes to primary packaging components that do not affect product contact (secondary or protective packaging elements).
• MiV-N13 — name or address changes for the establishment or testing facility of record.

For a holder managing dozens of small manufacturing tweaks per year across a portfolio, moving these into the notification lane instead of the variation lane cuts weeks off the ordinary refresh cycle.

6) Reconsideration pathway — a formal one-month window

Under Circular 12/2025 a refused MA application or a rejected variation required a fresh application cycle. Circular 32/2026 introduces a formal reconsideration pathway: within one month after receiving a notice of refusal or variation rejection, the registration establishment may request reconsideration. If reconsideration succeeds, the original dossier is approved without a fresh submission — retaining the fee status, the priority date, and the accumulated review record. For an applicant that received a marginal rejection on a single unresolved question, this is a meaningful de-risking of the last decision point.

Other changes worth flagging

• CEP as GMP evidence is narrowed: Certificates of Suitability to the European Pharmacopoeia no longer independently demonstrate GMP compliance for the manufacturing site — supplementary GMP evidence must be filed separately.
• Contract-manufacturing arrangements no longer require the foreign trader contract-manufacturing permit under Decree 69/2018/NĐ-CP for scenarios in scope of the circular.
• Six months of stability data (long-term and accelerated) is permitted for certain manufacturing-transfer applications and manufacturer changes.
• Electronic quality documents without a manufacturer seal may be certified by the finished-product manufacturer or the registration establishment.

The traditional-medicine boundary

Circular 32/2026 explicitly excludes traditional medicine (thuốc cổ truyền). Registration of traditional medicines and medicinal materials (dược liệu) continues under Circular 29/2025/TT-BYT and the transitional-period provisions currently mapped onto that framework. This boundary matters most for combination products that sit at the herbal/traditional interface: a product marketed as a modern herbal drug (thuốc dược liệu) can register under Circular 32, but a formulation prepared to a classical traditional pharmacopoeia stays under Circular 29. Registrants should verify their intended classification with DAV before assembling the dossier.

Transitional provisions — what happens to dossiers already in flight

The circular's transitional-provisions article gives applicants a controlled choice. Applications submitted before 1 October 2026 continue to be evaluated under Circular 12/2025 by default; the applicant may, on a per-application basis, request that DAV apply the more favourable provisions of Circular 32/2026 to the file already in evaluation. This is not an unrestricted regime switch — DAV assesses the request against the submission date and current evaluation status of each application. Applicants with in-flight dossiers should:

• Inventory each pending application by its submission date and current evaluation step.
• Identify which of the changes in the comparison table above would materially improve the outcome (typically: deferred CPP, foreign-document simplification, minor-variation reclassification).
• Prepare the written request for Circular 32 provisions with a specific rationale per application; do not batch-request across a portfolio.

What MA holders should do in the next six weeks

The window between publication of this article (16 August 2026) and Circular 32's effective date (1 October 2026) is six and a half weeks. The concrete actions that pay off:

• Assemble the pending-dossier map above; identify the two to five files where the Circular 32 provisions most materially help.
• Prime the CPP pipeline: for products with an in-flight SRA CPP application, plan to lodge the Vietnamese dossier without the CPP as soon as Circular 32 is in force, and file the CPP into the second supplementation round.
• Refresh the standard operating procedures for MiV-N variations to accommodate the new MiV-N11 through MiV-N13 categories — internal decision trees currently routing SUPAC Level 1 changes as MaV should be updated.
• Prepare an internal template for the reconsideration-request memo; for products with a track record of marginal refusals, the one-month window will close quickly.
• Verify that packaging and testing-facility changes on the roadmap for Q4 2026 can be filed as MiV-N12 or MiV-N13 under Circular 32 rather than as heavier variations under Circular 12/2025.
• Watch for the DAV implementation notice — the operational detail on consolidated-application criteria, on the exact electronic-verification channels for foreign documents, and on the format of the reconsideration request is expected to arrive as a Cục Quản lý Dược công văn between mid-September and 1 October.

Sources

• Ministry of Health — Circular 32/2026/TT-BYT (issued 29 July 2026, effective 1 October 2026). Full official text expected on vanban.chinhphu.vn and the Công báo shortly.
• Ministry of Health — Circular 12/2025/TT-BYT (issued 16 May 2025, effective 1 July 2025), the framework being replaced. Official PDF: https://datafiles.chinhphu.vn/cpp/files/vbpq/2025/5/12-byt.pdf
• Drug Administration of Vietnam — https://dav.gov.vn/info-document-319.html (Circular 12/2025 index page).
• ALIAT Legal — "Vietnam's Circular 32/2026/TT-BYT: Key Changes to Drug Marketing Authorization" (legal update).
• Mondaq — "Vietnam's New Drug Registration Regulations To Reduce Administrative Burden" (Tilleke & Gibbins commentary).
• LuatVietnam / Thư Viện Pháp Luật — Vietnamese-language summaries and consolidated text mirrors.
• Related pages on Medibase: <a href="/regulations/#tt-32-2026">Circular 32/2026 in the legal register</a>, <a href="/regulations/#tt-12-2025">Circular 12/2025 in the legal register</a>, <a href="/medicine/registration/">Drug Registration Process guide</a>, <a href="/regulations/calendar/">Regulatory effective-date calendar</a>.