Vaccines & Biological Products in Vietnam

Vaccines and biological products sit on a dedicated track within Vietnamese pharmaceutical regulation — sharing the Pharmacy Law umbrella with chemical drugs and traditional medicines but subject to additional requirements at every stage of the lifecycle. The regulatory architecture combines several Ministry of Health bodies, mandatory in-Vietnam lot release, segregated manufacturing, cold-chain distribution, dual-channel AEFI surveillance, and the National Immunisation Programme (Chương trình Tiêm chủng mở rộng — TCMR).

Legal definitions (Pharmacy Law Article 2):

• Vắc xin = a medicine containing antigens that confers immunological response, used for prevention or treatment of disease.
• Sinh phẩm = a medicine of biological origin, excluding in-vitro diagnostic biologicals, antibiotics, and low-molecular-weight substances of biological origin that can be isolated as pure compounds.
• Thuốc dược liệu (herbal medicines) — a separate medicine class governed by Chapter VI and the Medibase Traditional Medicine page; not part of the vaccine/biological regime.

Scope of this page:

• Multi-body NRA structure (DAV, NICVB, Trung tâm DI & ADR Quốc gia, NIHE) and WHO maturity-level status.
• Legal stack — Pharmacy Law + Decrees 163/2025 and 104/2016 + Circulars 12/2025, 28/2025, 11/2025, 34/2018, 31/2025, 26/2013.
• Registration pathway, Risk Management Plan, SRA / WHO PQ reliance, and lot-release interaction.
• Mandatory NICVB lot release.
• Biological GMP under TT 28/2025 (segregated dedicated lines).
• Cold-chain GSP.
• Dual-channel AEFI pharmacovigilance.
• National Immunisation Programme — 12 routine vaccines, 2025–2026 expansions (rotavirus nationwide 2026, HPV free 2026, PCV pilot).
• Adjacent topics: biosimilars, blood products, pandemic preparedness.

Multi-body NRA structure:

• Cục Quản lý Dược (DAV) — marketing authorisation, GMP inspection and certification, pharmacovigilance oversight, and post-marketing market surveillance.
• Viện Kiểm định Quốc gia Vắc xin và Sinh phẩm Y tế (NICVB) — the National Institute for Control of Vaccines and Biologicals. Conducts batch quality testing and the mandatory pre-release certification of every vaccine batch (domestic and imported). Publishes the "Bộ tiêu chuẩn xuất xưởng vắc xin – sinh phẩm" — the national release-criteria standards.
• Trung tâm Quốc gia về Thông tin thuốc và Theo dõi phản ứng có hại của thuốc (Trung tâm DI & ADR Quốc gia) — hosted at Hanoi University of Pharmacy under Decision 991/QĐ-BYT (2009). Runs the integrated ADR + AEFI database into which both pharmacovigilance and EPI clinical channels report.
• Viện Vệ sinh Dịch tễ Trung ương (NIHE) — operates the TCMR (national EPI) procurement, the national cold-chain warehouse, and the technical leadership of the immunisation service. Regional Pasteur Institutes (Nha Trang, TP. HCM, Tây Nguyên) and provincial CDCs operate the field network.

WHO NRA assessment: Vietnam was assessed at Maturity Level 3 (ML3) for the vaccine NRA in April 2021 (8 of 9 functions). WHO ran a follow-up Global Benchmarking Tool mission 30 June – 4 July 2025, with scope expanded from vaccines to the full pharmaceutical sector; the formal post-2025 outcome had not been publicly issued by mid-2026.

Legal stack (current from 1 July 2025 unless otherwise noted):

• Pharmacy Law 105/2016/QH13 Article 2 (definitions) as amended by Law 44/2024/QH15.
• Decree 163/2025/NĐ-CP — implementing the Pharmacy Law. Sets personnel qualifications including five years of relevant experience for the responsible expert and QA head at vaccine and biological manufacturing establishments.
• Circular 12/2025/TT-BYT — drug-registration framework; covers vaccines and biologicals; introduces mandatory Risk Management Plan for new chemical entities, vaccines and biologicals (probiotic biologicals exempt); SRA / WHO PQ reliance with a 5-year window after first SRA approval.
• Circular 28/2025/TT-BYT — GMP (replaces Circular 35/2018/TT-BYT). Adopts WHO-GMP, EU-GMP, PIC/S-GMP standards. Vaccines, biologicals containing live microorganisms, cytotoxics, betalactams, and sex hormones for contraception must be manufactured on segregated, dedicated lines with environmental containment. EU GMP Annex 2 (ATMPs / biologicals) is incorporated by reference.
• Circular 11/2025/TT-BYT — cross-cutting amendment of GPP (TT 02/2018), GDP (TT 03/2018), and GSP (TT 36/2018). The GSP component carries the cold-chain requirements that underpin vaccine storage.
• Decree 104/2016/NĐ-CP — immunisation activities. Defines the TCMR, AEFI definitions and reporting flow, vaccination establishments and personnel.
• Circular 34/2018/TT-BYT — implementing detail for Decree 104/2016 on immunisation activities and AEFI.
• Circular 31/2025/TT-BYT — pharmacy detail under Decree 163/2025 including pharmacovigilance obligations applicable to vaccines and biologicals.
• Circular 26/2013/TT-BYT — blood donation, collection, testing, processing, storage and clinical use of whole blood and blood components. Still in force as of June 2026. Plasma-derived medicinal products, recombinant proteins, monoclonal antibodies, stem cells and tissue/organ transplant materials are excluded and regulated as sinh phẩm under the Pharmacy Law and TT 12/2025.

Registration pathway under TT 12/2025/TT-BYT: The dossier follows an ICH-CTD / ASEAN ACTD-aligned modular structure: Module 1 administrative, Module 2 summaries, Module 3 quality (CMC), Module 4 nonclinical, Module 5 clinical. Vaccines and biologicals carry additional CMC expectations consistent with WHO biological reference standards. A Risk Management Plan is a mandatory component of the dossier for new chemical entities, all vaccines, and biologicals other than probiotic biologicals.

Reference-country / reliance pathway: TT 12/2025 recognises approvals by Stringent Regulatory Authorities (US FDA, EMA, MHRA, PMDA, Health Canada, TGA, Swissmedic) and the WHO Prequalification programme. Reliance dossiers must be filed within five years of the first SRA approval and include the foreign assessment report and a comparison table. A streamlined / abbreviated pathway applies to SRA-approved generics and to products in national programmes. For vaccines specifically, reliance review supports approval but does not waive the full CMC quality data submission or the mandatory in-Vietnam NICVB lot release.

National Lot Release (NICVB): Every batch of vaccine — domestic and imported — must undergo NICVB lot release before commercial release in Vietnam. NICVB applies the national "Bộ tiêu chuẩn xuất xưởng vắc xin – sinh phẩm" and publishes monthly batch release summary tables. The dossier submitted to NICVB includes the manufacturer's Certificate of Analysis, the lot-release certificate from the manufacturer-country NRA (where issued), and stability data; foreign NRA documentation does not substitute for the in-Vietnam release decision. Under TT 08/2022 and its successor TT 12/2025, NICVB-certified release specifications may be submitted after initial filing rather than at the dossier-filing stage, but remain a precondition to commercial release.

Biological GMP (TT 28/2025/TT-BYT): The GMP circular adopts WHO-GMP, EU-GMP and PIC/S-GMP and their applicable biological annexes (EU GMP Annex 2 for ATMPs and other biologicals). The biological-specific carve-out requires that vaccines, biologicals containing live microorganisms, cytotoxics, betalactams, and sex hormones for contraception be manufactured on segregated, dedicated lines with environmental containment appropriate to the biohazard or potency profile. Multi-product facilities are permitted only where the segregation, gowning, validated cleaning, and HVAC requirements are demonstrated to prevent cross-contamination — and only for product classes for which multi-product manufacture is regulatorily acceptable.

Cold-chain GSP: Vaccine storage and transport are governed by the general GSP framework — TT 36/2018/TT-BYT as amended by TT 11/2025/TT-BYT — with the practical biological annex applied. There is no vaccine-only cold-chain instrument. Operational requirements include validated cold rooms, refrigerators and freezers appropriate to each vaccine's storage profile (typically +2 to +8 °C for routine vaccines, −20 °C for some, ultra-low for mRNA-platform vaccines), continuous temperature and humidity monitoring with alarm thresholds, calibrated probes and excursion management procedures. NIHE operates the national TCMR cold-chain warehouse under GSP certification; DAV periodically publishes scope-of-storage adjustments to this certificate as new vaccines are added.

AEFI pharmacovigilance: Adverse Events Following Immunisation (AEFI) reporting flows through two integrated channels under Decree 104/2016 + Circular 34/2018 (with cross-reference into Circular 31/2025 for the broader pharmacovigilance obligations):

• EPI clinical chain — commune health station → district health centre → provincial CDC → Ministry of Health and NIHE.
• Pharmacovigilance chain — manufacturers, importers, hospitals, pharmacies and healthcare professionals report to the Trung tâm DI & ADR Quốc gia, which maintains the integrated ADR + AEFI database. Both channels feed the central database; NICVB contributes batch-level surveillance from its lot-release data. Severe AEFI events trigger a defined investigation procedure with monthly, quarterly and annual reporting cadences plus emergency reporting for serious or unexpected events.

National Immunisation Programme (TCMR): Anchored in Decree 104/2016 + Circular 34/2018 + annual implementation Decisions of the Minister of Health, the TCMR is funded from the state budget (re-centralised from 2023 under National Assembly Resolution 104/NQ-CP, after a brief decentralised period). Vietnam graduated from Gavi's main support window in 2016.

The 2025–2026 routine TCMR list comprises twelve vaccines delivered at approximately 33 million doses per year: hepatitis B birth dose, BCG (TB), DPT-VGB-Hib (pentavalent), bivalent oral polio (bOPV), inactivated polio (IPV), measles, measles-rubella (MR), Japanese encephalitis B, tetanus, DPT, Td, and rotavirus. The rotavirus vaccine was piloted in 2024 across 32 provinces, expanded in 2025, and rolled out nationwide in 2026. From 2026 the HPV vaccine is provided free of charge in the TCMR to 11-year-old girls. The PCV (pneumococcal conjugate) vaccine is in pilot from 2025 with an expansion target for 2026–2027. Influenza vaccination is targeted for routine inclusion by 2030. COVID-19 vaccines are not part of the routine TCMR list and are managed under separate arrangements.

Adjacent topics — biosimilars, blood, pandemic preparedness:

• Biosimilars are recognised under Vietnamese law. The technical guideline is Quyết định 16/QĐ-K2ĐT issued by Cục Khoa học công nghệ và Đào tạo (ASTT) — "Hướng dẫn nghiên cứu phi lâm sàng và lâm sàng thuốc sinh học tương tự (biosimilar)". The registration pathway runs through TT 12/2025/TT-BYT with comparability + clinical comparison dossier requirements.
• Blood products: TT 26/2013/TT-BYT governs whole blood and blood components for clinical use. There is no enacted "Luật Hiến máu" (Blood Donation Law); the area has been repeatedly proposed but not legislated as of June 2026 . Plasma-derived medicinal products and other purified biological products are sinh phẩm and follow TT 12/2025.
• Pandemic preparedness: framed by Luật Phòng chống bệnh truyền nhiễm 2007 + Pharmacy Law emergency-importation clauses + the COVID-19 Vaccine Fund (May 2021) and a rolling Pandemic Influenza Preparedness and Response Plan (PPRP) supported under the WHO PIP Framework. No consolidated post-COVID pandemic-preparedness statute has been enacted as of June 2026.

Pharmacy Law:

• Pharmacy Law 105/2016/QH13 — Article 2 defines vắc xin and sinh phẩm.
• Law 44/2024/QH15 — amends the Pharmacy Law including the definitions and the priority procedures for vaccine registration.

Implementing decrees:

• Decree 163/2025/NĐ-CP — implementing the Pharmacy Law. Personnel qualifications for vaccine and biological manufacturing.
• Decree 104/2016/NĐ-CP — immunisation activities. Definitions, TCMR, AEFI reporting flow.

Circulars (current):

• Circular 12/2025/TT-BYT — drug registration framework with mandatory Risk Management Plan for vaccines and biologicals and SRA / WHO PQ reliance pathway.
• Circular 28/2025/TT-BYT — GMP. Segregated, dedicated lines for vaccines, biologicals containing live microorganisms, cytotoxics, betalactams, and sex hormones for contraception. Replaces TT 35/2018.
• Circular 11/2025/TT-BYT — amends GPP (TT 02/2018), GDP (TT 03/2018), GSP (TT 36/2018) — cold-chain basis.
• Circular 34/2018/TT-BYT — implements Decree 104/2016 on immunisation activities and AEFI.
• Circular 31/2025/TT-BYT — pharmacy detail under Decree 163/2025 including pharmacovigilance for vaccines and biologicals.
• Circular 26/2013/TT-BYT — blood activities (whole blood and components). In force; plasma-derived and other purified biological products run through TT 12/2025.

Technical guidelines and operational standards:

• "Bộ tiêu chuẩn xuất xưởng vắc xin – sinh phẩm" — NICVB national release-criteria standards.
• Quyết định 16/QĐ-K2ĐT — biosimilar non-clinical and clinical study guideline (issued by Cục Khoa học công nghệ và Đào tạo).
• Quyết định 991/QĐ-BYT (2009) — establishment of Trung tâm DI & ADR Quốc gia.

Annual implementation:

• Quyết định 1987/QĐ-BYT (2024) — TCMR plan for 2025.
• Quyết định 906/QĐ-BYT (2025) — 2025 revisions.
• Annual implementation Decisions of the Minister of Health for each calendar year.

Penalties:

• Decree 117/2020/NĐ-CP as amended by Decree 124/2021/NĐ-CP — administrative penalties.
• Penal Code 2015 — criminal liability for gross 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

Decrees:

• Decree 163/2025/NĐ-CP — https://vanban.chinhphu.vn/?pageid=27160&docid=214322
• Decree 104/2016/NĐ-CP — https://vanban.chinhphu.vn/default.aspx?pageid=27160&docid=186073

Circulars:

• Circular 12/2025/TT-BYT (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
• Circular 28/2025/TT-BYT (GMP) — https://thuvienphapluat.vn/van-ban/The-thao-Y-te/Thong-tu-28-2025-TT-BYT-Thuc-hanh-tot-san-xuat-thuoc-nguyen-lieu-lam-thuoc-663340.aspx
• Circular 11/2025/TT-BYT (GPP / GDP / GSP) — https://english.luatvietnam.vn/y-te/circular-11-2025-tt-byt-amend-circular-02-2018-tt-byt-circular-03-2018-tt-byt-and-circular-36-2018-tt-byt-400532-d1.html
• Circular 34/2018/TT-BYT (Decree 104 implementation) — https://thuvienphapluat.vn/van-ban/The-thao-Y-te/Thong-tu-34-2018-TT-BYT-huong-dan-Nghi-dinh-104-2016-ND-CP-ve-hoat-dong-tiem-chung-400318.aspx
• Circular 31/2025/TT-BYT (pharmacy detail incl. PV) — 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 26/2013/TT-BYT (blood products) — https://thuvienphapluat.vn/van-ban/The-thao-Y-te/Thong-tu-26-2013-TT-BYT-nam-2013-huong-dan-hoat-dong-truyen-mau-214176.aspx

Technical guidelines:

• Biosimilar guideline (Quyết định 16/QĐ-K2ĐT, ASTT) — http://asttmoh.vn/wp-content/uploads/2016/05/Huong-dan-Biosimilar-Final.pdf
• TCMR 2025 plan (Quyết định 1987/QĐ-BYT) — https://luatvietnam.vn/y-te/quyet-dinh-1987-qd-byt-2024-ke-hoach-tiem-chung-mo-rong-nam-2025-359819-d1.html

Operational portals:

• National Institute for Control of Vaccines and Biologicals (NICVB) — https://nicvb.org.vn
• NICVB lot release — https://nicvb.org.vn/bo-phan-qms/xuat-xuong-lo-vac-xin-mot-chuc-nang-quan-trong-trong-he-thong-quan-ly-quoc-gia-c16-105.aspx
• National Institute of Hygiene and Epidemiology (NIHE) — https://nihe.org.vn
• Drug Administration of Vietnam (DAV) — https://dav.gov.vn
• National DI & ADR Centre — https://canhgiacduoc.org.vn

International:

• WHO Vietnam — NRA ML3 (2021) — https://www.who.int/vietnam/news/detail/12-04-2021-viet-nam-s-vaccine-regulatory-system-reaches-who-s-second-highest-level
• WHO list of NRAs at ML3 / ML4 — https://cdn.who.int/media/docs/default-source/medicines/regulatory-systems/wla/list-of-nras-operating-at-ml3-and-ml4.pdf
• WHO Vietnam — pandemic preparedness — https://www.who.int/news-room/feature-stories/detail/viet-nam-journey-towards-pandemic-preparedness-and-emerging-regional-leadership

Medibase cross-references:

• Reference — Drug Registration Process — /medicine/registration/
• Reference — Clinical Trials & BE — /medicine/clinical-trials-be/
• Reference — Special-Control Medicines — /medicine/special-control/
• Reference — Distribution & Retail (cold chain in GSP) — /medicine/distribution-retail/
• Reference — Pharmacovigilance — /medicine/pharmacovigilance/

12 April 2021 — WHO assesses Vietnam's vaccine NRA at Maturity Level 3 (ML3), 8 of 9 functions.

21 November 2024 — National Assembly passes Law 44/2024/QH15 amending the Pharmacy Law including the priority procedures for vaccine registration and investment incentives for vaccine and biological R&D and production.

16 May 2025 — Ministry of Health issues Circular 12/2025/TT-BYT on drug registration; introduces mandatory Risk Management Plan for vaccines and biologicals and the SRA / WHO PQ reliance pathway.

29 June 2025 — Government issues Decree 163/2025/NĐ-CP, including personnel-qualification rules for vaccine and biological manufacturing.

30 June – 4 July 2025 — WHO Global Benchmarking Tool mission to Vietnam, with scope expanded from vaccines to the full pharmaceutical sector. Outcome publication pending.

1 July 2025 — Simultaneous effective date: amended Pharmacy Law (Law 44/2024), Decree 163/2025, Circular 12/2025/TT-BYT (registration), Circular 28/2025/TT-BYT (GMP), Circular 11/2025/TT-BYT (GPP / GDP / GSP), Circular 31/2025/TT-BYT (pharmacy detail).

2024 — Rotavirus vaccine piloted in 32 provinces under TCMR.

2025 — Rotavirus expanded; PCV (pneumococcal conjugate) pilot begins in TCMR.

2026 — Rotavirus vaccine rolled out nationwide under TCMR. HPV vaccine added free of charge in TCMR for 11-year-old girls. PCV expansion continues.