Clinical trials in Vietnam are authorized through Vietnam’s Ministry of Health (MOH). Sponsors and CROs often shorthand this as “DAV approval” after the Drug Administration of Vietnam (DAV), the MOH body that regulates pharmaceutical products — but DAV’s core mandate is drug and medicine marketing authorization and import licensing, not the clinical trial application itself. The unit that actually manages clinical trial protocol review and study approval is a separate MOH body, the Administration of Science, Technology and Training (ASTT), working alongside Vietnam’s ethics committee system. This guide sets out who does what, what a trial needs before it can start, and where DAV genuinely fits into the pathway.
Who actually approves a clinical trial in Vietnam
Four bodies are involved, and a sponsor needs to understand the sequence, not just the names:
- Ministry of Health (MOH) — the overarching regulatory authority. Final sign-off on a study approval dossier is issued in the Minister of Health’s name.
- Administration of Science, Technology and Training (ASTT) — the MOH department that manages the clinical trial registration and review process day to day: dossier intake, validity checks, coordinating ethics review, and preparing the file for ministerial approval.
- National Ethics Committee in Biomedical Research (NECBR) — conducts the national-level ethics review of the protocol as part of the ASTT-managed process.
- Councils/Committees of Ethics in Biomedical Research at Grass-Root Level (CEBRGLs) — institutional ethics committees. Approval at this level is a prerequisite: the study approval dossier submitted to ASTT must already include evidence of institutional ethics approval, so institutional review has to happen before, not in parallel with, the national regulatory submission.
Where DAV fits: DAV (Cục Quản lý Dược) is the MOH agency responsible for pharmaceutical product registration, GMP/GLP oversight of manufacturers, and import permits for pharmaceutical products — including, in many cases, the investigational product being brought into Vietnam for the trial. For a trial using an imported investigational medicinal product (IMP), securing the relevant DAV-administered import documentation runs alongside, not instead of, the ASTT-managed clinical trial approval. Some secondary sources describe DAV itself as the clinical trial approving authority; that conflates DAV’s drug-registration/import role with ASTT’s trial-review role, and sponsors should not assume a DAV drug filing substitutes for ASTT/MOH clinical trial approval, or vice versa.
The two-part dossier: registration and study approval
Vietnam’s process is generally described as running in two stages, submitted to ASTT:
- Registration dossier (submitted by the sponsor) — includes the registration application form and a summary Investigator’s Brochure. This is the initial filing that puts the trial on record.
- Study approval dossier (submitted by the trial institution) — the substantive package, which typically includes the approval application form, the complete Investigator’s Brochure with GMP/GLP compliance evidence, a copy of the ASTT registration approval, the institution’s pharmaceutical business certificate, the sponsor-institution agreement, the protocol and Case Report Form, the Principal Investigator’s CV and GCP certificate, the Informed Consent Form, the CEBRGL (institutional ethics) evaluation report, and investigational product labeling.
Institutional ethics committee (CEBRGL) approval has to be secured first, since evidence of it is a required component of the study approval dossier rather than something that can be filed concurrently with ASTT.
Reported review timelines
Published regulatory-intelligence summaries (not Vietnamese government primary text, so treat as indicative rather than guaranteed) describe timelines along these lines: ASTT performs a validity/completeness check on the registration dossier within about 5 working days, then issues a decision within roughly 5 working days of the dossier being complete. For the study approval dossier, ASTT again runs a validity check (~5 working days), NECBR holds its review meeting within about 25 days, and the final approval submission to the Minister of Health follows within roughly 5 working days of the NECBR report. Institutional CEBRGL review is commonly cited at around 30 days. Sponsors should confirm current timelines and any fee schedule directly with ASTT/DAV or a Vietnam-qualified regulatory affairs partner before building a submission timeline, since these figures come from secondary regulatory-intelligence sources rather than a primary government publication CASRAI independently verified.
The legal framework, and a regulation in transition
Vietnam’s clinical trial and pharmaceutical regulatory framework has been actively updated through 2024-2026. Sources describe the following instruments as current or newly in force (verify the applicable version directly with MOH/ASTT/DAV before relying on any single circular number, given how recently several of these took effect):
- Law on Pharmacy (Law No. 44/2024/QH15, amending the original 2016 Law on Pharmaceuticals) — the top-level statute underpinning drug and clinical trial regulation.
- Circular No. 50/2025/TT-BYT, reported as MOH’s updated regulations on clinical trials, with an effective date around late February 2026.
- Circular No. 29/2018/TT-BYT, the Good Clinical Practice (GCP) guideline circular for clinical drug trials that has served as the standing GCP reference.
- Circular No. 43/2024/TT-BYT, covering the establishment and operation of ethics committees.
- Decree No. 42/2025/ND-CP, on MOH’s functions, tasks, and organizational structure.
- Circular No. 12/2025/TT-BYT (effective July 1, 2025), which updated drug and pharmaceutical-ingredient registration — the DAV-administered track that matters for sponsors bringing an investigational or comparator product into the country.
Because this framework has moved through several instruments in close succession, the safest practice for a sponsor or CRO is to confirm the currently governing circular for both the clinical trial application track (ASTT) and the drug import/registration track (DAV) at the time of filing, rather than relying on any single number found in a secondary source, including this one.
Good Clinical Practice expectations
Vietnam’s clinical trial conduct standards are aligned to ICH Good Clinical Practice principles, consistent with the broader regional trend of GCP harmonization. As with any ICH-GCP-aligned jurisdiction, the Principal Investigator is expected to hold current GCP training/certification, the protocol and informed consent process must meet GCP standards, and the trial is subject to inspection. See CASRAI’s guide to trial design under ICH E8(R1)/E9 and the current clinical trial protocol definition for background on what a GCP-compliant protocol needs to contain.
What this means for sponsors and CROs planning a Vietnam site
- Budget for a two-track filing: the ASTT-managed clinical trial approval (registration dossier, then study approval dossier) and, where the investigational product is imported, the DAV-administered import documentation. Treat these as parallel workstreams, not one submission.
- Sequence ethics approval first. Institutional CEBRGL sign-off has to exist before the study approval dossier can go to ASTT, so it belongs early in the site-activation timeline, not after regulatory filing.
- Don’t assume a single point of contact. A sponsor’s regulatory affairs lead will typically be dealing with ASTT for the trial application, NECBR/CEBRGL for ethics, and DAV separately for any product import/registration needs — distinct offices with distinct dossiers.
- Verify the governing circular at filing time. Given the pace of regulatory updates through 2024-2026 (a new Pharmacy Law, a new MOH organizational decree, and a new clinical trial circular in close succession), confirm the currently applicable version with local regulatory counsel or directly with ASTT/DAV rather than relying on a circular number from an older filing.
Frequently asked questions
Does DAV approve clinical trials in Vietnam?
Not directly, in the sense sponsors from other jurisdictions might expect. DAV’s role is drug/pharmaceutical product registration, manufacturer GMP/GLP oversight, and import permitting under the Ministry of Health. The unit that reviews and approves the clinical trial application itself is the Administration of Science, Technology and Training (ASTT), also under MOH, with final approval issued by the Minister of Health. DAV becomes relevant to a trial specifically when an investigational or comparator product needs to be imported into Vietnam.
How is Vietnam’s process similar to other Southeast Asian pathways?
Like Malaysia’s NPRA CTIL/CTX process, the Philippines’ FDA application process, and Indonesia’s BPOM approval process, Vietnam separates a product-regulatory track from an ethics-review track and requires both before enrollment can begin. Vietnam’s distinctive feature is that the product-regulatory function (DAV) and the trial-review function (ASTT) sit in genuinely separate MOH departments rather than a single combined authority, which is why the two are easy to conflate but shouldn’t be.
Do trial phases I-IV all require MOH/ASTT approval?
Regulatory-intelligence summaries describe MOH approval as applying across trial phases I through IV, consistent with how most ICH-aligned jurisdictions treat interventional drug trials. Confirm phase-specific requirements and any exemptions with ASTT directly for a given protocol.
Is ethics committee approval separate from ASTT/MOH approval?
Yes, and it comes first in sequence. Institutional-level approval from a CEBRGL is a required, evidenced component of the study approval dossier submitted to ASTT, and NECBR conducts a further national-level ethics review as part of ASTT’s process before the file goes to the Minister of Health for final sign-off.
This guide summarizes Vietnam’s clinical trial regulatory structure based on Vietnam’s Law on Pharmacy and its implementing decrees/circulars as described in regulatory-intelligence sources, including NIAID’s ClinRegs country database. Vietnam’s framework has changed multiple times in 2024-2026; verify the current governing circular and any fee/timeline specifics directly with ASTT, DAV, or qualified local regulatory counsel before relying on them for a live submission.
