Clinical Trials & Bioequivalence in Vietnam

Clinical trials and bioequivalence (BE) studies sit in their own corner of Vietnamese pharmaceutical regulation, distinct from the marketing-authorisation track described in the Medibase Drug Registration Process page. The operating authority is different — Cục Khoa học công nghệ và Đào tạo (ASTT / K2ĐT) under the Ministry of Health runs the clinical-trial procedure, not DAV. The legal stack is different — Pharmacy Law Chapter XI rather than the registration Mục 2 of Chương V. And the documentary framework is different — GCP / GLP / WHO and ICH-GCP alignment rather than the ASEAN ACTD or ICH-CTD format used for registration.

Two distinct regimes share this page:

• Clinical trials (thử thuốc trên lâm sàng) — the in-human studies required for new chemical entities, biologicals, vaccines, traditional medicines being registered for the first time, and certain registration-extension scenarios. Phased per Article 86 (phases I–IV).
• Bioequivalence studies (thử tương đương sinh học) — the pharmacokinetic studies required to demonstrate that a generic product is interchangeable with the reference listed drug. Mandatory for active ingredients listed in Appendix I of Circular 07/2022/TT-BYT.

Scope of this page:

• Authority structure: ASTT, DAV, National Ethics Committee.
• Legal stack — Pharmacy Law Chapter XI, Decree 163/2025 Article 23, Circular 50/2025 (new GCP + trial procedures), Circular 43/2024 (ethics committees), Circular 07/2022 (BE-required list), Circular 12/2025 (registration linkage).
• Clinical-trial authorisation pathway: dossier, timelines, NEC review, Minister approval.
• Bioequivalence studies: when required, design requirements, recognised BE centres, foreign-data acceptance.
• Ethics committees: national and institutional, ICH-GCP alignment.
• Special-population and vaccine considerations.
• Sponsor and CRO obligations.
• Trial-registry status.
• Sanctions.

Authority structure:

• Bộ trưởng Bộ Y tế holds final approval authority for every clinical trial.
• Cục Khoa học công nghệ và Đào tạo (ASTT / K2ĐT) — the operating directorate. Receives the trial-registration dossier, runs the validity check, coordinates the ethics committee referral, and submits the approval recommendation to the Minister. ASTT is not the Drug Administration of Vietnam (DAV) — DAV is responsible for the investigational-product (IP) import permit and for the post-trial marketing-authorisation dossier, but the trial procedure itself sits with ASTT.
• Hội đồng đạo đức trong nghiên cứu y sinh học cấp quốc gia (National Ethics Committee for Health Research) — reviews protocols for scientific and ethical merit; its report is mandatory input to the Minister's approval. Institutional ethics committees at host sites also play a role.
• Sở Y tế cấp tỉnh participates in inspections of trial sites in their province under the general health-sector inspection framework.

Legal stack (current and upcoming):

• Pharmacy Law 105/2016/QH13, Chương XI "Thử thuốc trên lâm sàng, thử tương đương sinh học của thuốc" — Articles 86–94. Article 86 (phases I–IV), Article 87 (trial requirement for registration), Article 88 (investigational-product requirements), Article 89 (drugs requiring or exempt from trials — amended by Law 44/2024/QH15 at clause 3.c for pre-2017 herbal registrations), Article 90 (participant eligibility), Article 91 (participant rights and obligations), Article 92 (sponsor rights and responsibilities), Article 93 (site rights and responsibilities), Article 94 (approval principles and authority).
• Decree 163/2025/NĐ-CP — Article 23 governs technical, facility and personnel requirements for clinical-trial service establishments and bioequivalence laboratories, cross-referencing GLP for the bioanalytical phase and GCP for the clinical phase; permits BE laboratories to subcontract the clinical phase to a GCP-certified site .
• Circular 50/2025/TT-BYT — the headline reform. Issued 31 December 2025, signed Deputy Minister Nguyễn Tri Thức; effective 27 February 2026. Seven chapters, five appendices. Explicitly references WHO and ICH-GCP, with an obligation to update within three months of international guideline changes. Replaces Circular 29/2018/TT-BYT in full, Article 9 of Circular 10/2020/TT-BYT on BE procedure, and Circular 08/2014/TT-BYT on trial-support activities. Transitional rule allows dossiers filed before 27 February 2026 to be processed under TT 29/2018 or TT 50/2025 at the applicant's option.
• Circular 29/2018/TT-BYT — the predecessor GCP and trial-procedure circular. In force through 26 February 2026; replaced from 27 February 2026 by TT 50/2025.
• Circular 43/2024/TT-BYT — issued 12 December 2024, effective 1 February 2025. Governs the formation, organisation and operation of ethics committees in health-research, at both the national level and institutional level. Replaces Circular 04/2020/TT-BYT. Five-year terms with at least 20% rotation; ICH-GCP-aligned review functions.
• Circular 07/2022/TT-BYT — issued 5 September 2022, effective 1 November 2022. Defines the list of active ingredients for which an in-vivo BE study is mandatory (Appendix I). Selection criteria are narrow therapeutic index, low or variable bioavailability, key Rx classes (cardiovascular, antidiabetic, antibiotic, antipsychotic, antiepileptic, antiviral), and national-programme drugs (HIV, TB, malaria, mental health). Still in force.
• Circular 12/2025/TT-BYT — the registration framework. Issued 16 May 2025, effective 1 July 2025; replaced Circular 08/2022/TT-BYT and Circular 32/2018/TT-BYT. Classifies generics as "BE-proven" only when the BE dossier complies with TT 07/2022. Foreign BE studies are accepted subject to TT 07/2022 + the ASEAN BE Guideline.

Clinical-trial authorisation pathway (Circular 50/2025): The procedure is two-stage. The trial-registration dossier (Form 6 and an Investigator's Brochure summary) is filed with ASTT; on validity acceptance, the sponsor submits the study-approval dossier — full Investigator's Brochure with GMP and GLP evidence for the IP, protocol with Form 8, case report form, investigator CVs and GCP certificates, the informed-consent form, the institutional ethics-committee approval, and IP labelling. Documents may be in Vietnamese or English with a notarised Vietnamese translation. Statutory timelines under TT 29/2018, which TT 50/2025 is expected to mirror in spirit: validity check 5 working days; supplement window 60 days; ASTT operational decision 5 working days; site-dossier validity 5 working days; National Ethics Committee meeting within 25 days of the complete dossier; submission to the Minister 5 working days after the NEC report; correction window 90 days.

Bioequivalence studies: A BE study demonstrates that the rate and extent of absorption of a generic active ingredient match those of the reference listed drug within statistically defined limits. In Vietnam, BE is mandatory for the active ingredients listed in Appendix I of Circular 07/2022/TT-BYT. Common triggers are narrow therapeutic index (e.g. cyclosporine, levothyroxine, lithium, phenytoin, warfarin), low or variable bioavailability, antibiotic and antiviral classes, and national-programme drugs. Foreign BE studies are accepted where compliant with TT 07/2022 and the ASEAN BE Guideline; this is the operative rule for multinational generics filed under TT 12/2025/TT-BYT. Recognised Vietnamese BE centres include the Trung tâm Đánh giá Tương đương sinh học at the Viện Kiểm nghiệm thuốc Trung ương (NIDQC, Hanoi) and the BE centre at the Viện Kiểm nghiệm thuốc TP. HCM. DAV publishes a list of recognised BE centres; the most recent public snapshot is from May 2021 and should be cross-checked with DAV for current status.

Ethics committees (Circular 43/2024): Circular 43/2024 restructured the ethics-committee regime, replacing Circular 04/2020/TT-BYT from 1 February 2025. The instrument defines two levels: a national-level committee ("Hội đồng đạo đức trong nghiên cứu y sinh học cấp quốc gia") established by the Minister of Health, and institutional committees established by the head of each host institution. Members serve five-year terms with at least 20% rotation between terms. Chair and vice-chair qualifications are specified. Review functions follow ICH-GCP. For pediatric trials (participants under 16), Circular 43/2024 mandates additional ethical safeguards including parental or guardian informed consent and child assent where developmentally appropriate; no Vietnam-specific paediatric design rules exist beyond default ICH-GCP and WHO guidance.

Special-population and vaccine considerations:

• Vaccine and biological-product trials follow the same pathway as small-molecule drug trials. Under Circular 12/2025/TT-BYT, certain trial phases may be exempted when the vaccine or biological is already approved by a recognised Stringent Regulatory Authority — a decision made on the recommendation of the Advisory Council.
• No permanent emergency-use clinical-trial pathway exists in Vietnamese law. The COVID-era Nanocovax pathway was authorised under ad-hoc resolutions, not a standing framework.

Sponsor and CRO obligations: Foreign sponsors are not required to establish a Vietnamese legal entity to run a trial; Article 92 of the Pharmacy Law and Circular 50/2025 contemplate both domestic and foreign sponsors. In practice, multinational sponsors contract a Vietnamese contract-research organisation (CRO) for in-country execution; Vietnamese CROs providing trial-support services must register with ASTT. Insurance, indemnification and compensation for trial participants are not specified in domestic regulatory text — practice instead relies on the clinical-trial agreement between sponsor and site, drawing on ICH-GCP principles. This is a recognised gap in domestic Vietnamese law.

Trial registry: Vietnam does not operate a mandatory national clinical-trial registry. ASTT maintains an internal tracking database that is not publicly accessible. Sponsors are encouraged but not required to register their trials on ClinicalTrials.gov or a primary registry recognised by the WHO International Clinical Trials Registry Platform (ICTRP). Vietnam itself is not, as of June 2026, a Primary Registry recognised by the ICTRP.

Sanctions: Administrative penalties for breaches in clinical-trial conduct are governed by Decree 117/2020/NĐ-CP as amended by Decree 124/2021/NĐ-CP, covering both research-conduct breaches and participant-protection breaches. Sanctions range from warning and fines to suspension of trial authorisation and revocation of the responsible investigator's CCHND. Criminal liability under the Penal Code can attach for gross participant-protection breaches .

Pharmacy Law:

• Pharmacy Law 105/2016/QH13 — Chương XI "Thử thuốc trên lâm sàng, thử tương đương sinh học của thuốc", Articles 86–94.
• Law 44/2024/QH15 — amends Article 89 clause 3.c of the Pharmacy Law for pre-2017 herbal-medicine registrations.

Implementing decree:

• Decree 163/2025/NĐ-CP — Article 23 governs technical, facility and personnel requirements for clinical-trial service establishments and bioequivalence laboratories.

Implementing circulars (current and upcoming):

• Circular 50/2025/TT-BYT — the headline reform. Issued 31 December 2025; effective 27 February 2026. GCP standard and trial-procedure framework; replaces TT 29/2018/TT-BYT, Article 9 of TT 10/2020/TT-BYT (BE procedure), and TT 08/2014/TT-BYT (trial-support activities).
• Circular 29/2018/TT-BYT — the prior GCP and trial-procedure circular. In force through 26 February 2026. Transitional rule under TT 50/2025 allows dossiers filed before that date to be processed under either circular at the applicant's option.
• Circular 43/2024/TT-BYT — ethics committees in health research, national and institutional. Effective 1 February 2025. Replaces Circular 04/2020/TT-BYT.
• Circular 07/2022/TT-BYT — list of active ingredients requiring in-vivo BE study. Effective 1 November 2022. Appendix I defines the BE-mandatory list.
• Circular 12/2025/TT-BYT — drug registration framework. Effective 1 July 2025. Classifies BE-proven generics by reference to TT 07/2022.

Adjacent and prior instruments:

• Circular 10/2020/TT-BYT — its Article 9 (BE procedure) is replaced by TT 50/2025; the remainder addresses other topics.
• Circular 08/2014/TT-BYT — trial-support activities; replaced by TT 50/2025.

Penalties:

• Decree 117/2020/NĐ-CP as amended by Decree 124/2021/NĐ-CP — administrative penalties in the healthcare field, including clinical-trial breaches and participant-protection breaches.
• Penal Code 2015 — criminal liability for gross participant-protection breaches.

Pharmacy 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/NĐ-CP — https://vanban.chinhphu.vn/?pageid=27160&docid=214322

Circulars:

• Circular 50/2025/TT-BYT (GCP + trial procedure, effective 27 Feb 2026) — https://vanban.chinhphu.vn/?pageid=27160&docid=216447
• Circular 50/2025/TT-BYT (mirror, full text) — https://thuvienphapluat.vn/van-ban/The-thao-Y-te/Thong-tu-50-2025-TT-BYT-quy-dinh-ve-thu-thuoc-tren-lam-sang-thu-tuong-duong-sinh-hoc-cua-thuoc-648617.aspx
• Circular 29/2018/TT-BYT (predecessor, in force through 26 Feb 2026) — see thuvienphapluat.vn search.
• Circular 43/2024/TT-BYT (ethics committees) — https://luatvietnam.vn/y-te/thong-tu-43-2024-tt-byt-hoi-dong-dao-duc-trong-nghien-cuu-y-sinh-hoc-380339-d1.html
• Circular 07/2022/TT-BYT (BE-required substance list) — https://vbpl.vn/TW/Pages/vbpq-toanvan.aspx?ItemID=158387
• Circular 12/2025/TT-BYT (drug registration) — https://thuvienphapluat.vn/van-ban/The-thao-Y-te/Thong-tu-12-2025-TT-BYT-dang-ky-luu-hanh-thuoc-nguyen-lieu-lam-thuoc-630038.aspx

Operational portals:

• Cục Khoa học công nghệ và Đào tạo (ASTT) — https://asttmoh.vn — ASTT announcements on TT 43/2024 and TT 50/2025 issuance.
• Drug Administration of Vietnam (DAV) — BE-centre list — https://dav.gov.vn/danh-sach-co-so-thu-tuong-duong-sinh-hoc-cua-thuoc-n3127.html
• National Institute of Drug Quality Control (NIDQC, Hanoi) — https://nidqc.gov.vn/danh-gia-tuong-duong-sinh-hoc
• Institute of Drug Quality Control HCMC — https://vienkiemnghiem.gov.vn/cac-don-vi-truc-thuoc/cac-khoa-chuyen-mon/trung-tam-danh-gia-tuong-duong-sinh-hoc/

International:

• WHO ICTRP — https://www.who.int/clinical-trials-registry-platform
• ClinicalTrials.gov — https://clinicaltrials.gov
• ICH-GCP — https://ichgcp.net
• NIH ClinRegs (Vietnam) — https://clinregs.niaid.nih.gov/country/vietnam

Penalties:

• Decree 117/2020/NĐ-CP — https://vbpl.vn/boyte/Pages/vbpq-van-ban-goc.aspx?ItemID=144229

Medibase cross-references:

• Reference — Drug Registration Process — /medicine/registration/
• Reference — Special-Control Medicines — /medicine/special-control/
• Reference — Traditional Medicine & Medicinal Materials — /medicine/traditional-medicine/
• Reference — Drug Import & Export — /medicine/import-export/

21 November 2024 — National Assembly passes Law 44/2024/QH15 amending the Pharmacy Law including Chapter XI Article 89(3)(c).

12 December 2024 — Ministry of Health issues Circular 43/2024/TT-BYT on ethics committees, replacing Circular 04/2020/TT-BYT.

1 February 2025 — Circular 43/2024/TT-BYT enters into force.

16 May 2025 — Ministry of Health issues Circular 12/2025/TT-BYT on drug registration, classifying BE-proven generics by reference to TT 07/2022.

29 June 2025 — Government issues Decree 163/2025/NĐ-CP, including Article 23 on clinical-trial and BE establishment conditions.

1 July 2025 — Simultaneous effective date: amended Pharmacy Law (Law 44/2024), Decree 163/2025, Circular 12/2025/TT-BYT.

31 December 2025 — Ministry of Health issues Circular 50/2025/TT-BYT (signed Deputy Minister Nguyễn Tri Thức) — the headline GCP and trial-procedure reform.

27 February 2026 — Circular 50/2025/TT-BYT enters into force, replacing Circular 29/2018/TT-BYT in full, Article 9 of Circular 10/2020/TT-BYT (BE procedure), and Circular 08/2014/TT-BYT (trial-support activities). Transitional rule allows pre-27-Feb dossiers to be processed under either circular.