Drug Registration Process in Vietnam

A marketing authorization (MA) — known in Vietnamese as giấy đăng ký lưu hành thuốc and indexed by a registration number (số đăng ký, SĐK / VN-…) — is the precondition for any finished pharmaceutical product to be imported, manufactured, marketed, or reimbursed by Vietnam Social Security (VSS) in Vietnam. It is issued by the Drug Administration of Vietnam (Cục Quản lý Dược — DAV), an agency under the Ministry of Health (Bộ Y tế).

Scope of this page:

• What an MA is, who may hold one, and the seven recognised registration categories (new chemical entities, generics, biologicals, biosimilars, vaccines, herbal/traditional medicines, and pharmaceutical starting materials).
• The full step-by-step DAV process, from pre-submission GMP/registrant qualification through dossier acceptance, expert evaluation, Advisory Council vote, and MA issuance.
• Statutory timelines versus what applicants actually experience — including the 2022–2024 backlog crisis that drove the Pharmacy Law amendment.
• The practical pitfalls that account for most rejection cycles: CPP/FSC legalisation, bioequivalence-site recognition, ASEAN ACTD vs ICH-CTD modules, Vietnamese-language labelling, and pharmacovigilance plans.

How to read this page: The overview below sets the framework. The "Key documents" section is the authoritative legal stack, in the order it should be consulted. "Recent updates" focuses on the 2024–2025 reform package that re-engineered the process. "Resources & links" gives the operational portals applicants actually log into. The FAQ closes the most frequent buyer/sponsor questions.

Who needs an MA in Vietnam:

• Any finished pharmaceutical product imported for commercial distribution.
• Any locally manufactured finished pharmaceutical product.
• Pharmaceutical starting materials (active substances, excipients, certain packaging) — registered under the same Circular 08/2022/TT-BYT framework.
• Vaccines and biologicals — registered under the same framework but routed through specialised expert sub-committees and subject to lot-release control.

Who does NOT need an MA:

• Investigational medicinal products for an approved clinical trial — covered by the clinical-trial authorisation, not by MA.
• Drugs imported under a named-patient or compassionate-use permit issued directly by DAV.
• Rare-disease drugs or drugs for outbreak response imported under a special "đơn hàng nhập khẩu" import licence (Article 60, Pharmacy Law 105/2016/QH13).

Validity of an MA:

• 5 years is the default term for chemical drugs, biologicals, vaccines, and herbal medicines.
• 3 years applies in narrower cases: products with limited clinical data, new active substances pending post-approval studies, or products granted an MA on a conditional / reference-CPP basis.
• Under Law 44/2024/QH15 (in force 1 July 2025), an MA whose renewal dossier is filed before expiry and meets the completeness check is automatically extended in defined cases — closing the cliff-edge that caused the 2022–2024 supply crisis.

Pharmacy Law (Luật Dược):

• Law on Pharmacy No. 105/2016/QH13 — foundational law on pharmacy practice, drug registration, manufacture, and distribution; in force from 1 January 2017. Article 56 sets the MA requirement; Article 58 defines registration validity; Article 59 sets renewal rules; Article 60 governs special import permits.
• Law No. 44/2024/QH15 — amends and supplements the Pharmacy Law; effective 1 July 2025. Registration-relevant changes: streamlined renewal with automatic extension in defined cases, faster pathway for SRA-approved drugs, dedicated innovative-drug pathway, and a new statutory basis for reference-dossier reliance on SRA decisions.

Implementing decrees (Nghị định):

• Decree 54/2017/NĐ-CP — detailed implementation of the Pharmacy Law (drug registration, sourcing of starting materials, special import).
• Decree 155/2018/NĐ-CP — amends Decree 54; cuts business conditions and simplifies administrative procedures.
• National Assembly Standing Committee Resolution 80/2023/QH15 — emergency measure that extended the validity of expiring MAs whose renewal dossiers were stuck in the DAV backlog; the practical bridge to the Pharmacy Law amendment.

Drug registration — currently in force:

• Circular 08/2022/TT-BYT — registration of pharmaceuticals and pharmaceutical starting materials. The operational rulebook for what a dossier must contain, how it is submitted, and how DAV evaluates it. Effective from 20 June 2022; supersedes substantial parts of Circular 32/2018/TT-BYT.
• Circular 16/2023/TT-BYT — supplements Circular 08/2022 on bioequivalence site recognition and lot-release for certain biologicals.

Drug registration — historical context:

• Circular 32/2018/TT-BYT — the predecessor framework; cited in many still-valid MA decisions issued before mid-2022.
• Circular 44/2014/TT-BYT — the earlier framework; relevant only for tracing the lineage of very old MAs.

GxP certification used in dossier:

• Circular 35/2018/TT-BYT — Good Manufacturing Practice (WHO-GMP, PIC/S-GMP, and EU-GMP recognition). Sets the GMP tier of the manufacturing site, which determines which tender groups the product can later enter.
• Circular 36/2018/TT-BYT — Good Storage Practice (GSP).
• Circular 03/2018/TT-BYT — Good Distribution Practice (GDP).
• Circular 02/2018/TT-BYT — Good Pharmacy Practice (GPP).

Labelling, leaflet, and pharmacovigilance:

• Circular 01/2018/TT-BYT — drug labelling and patient information leaflets (tờ hướng dẫn sử dụng); Vietnamese language is mandatory.
• Circular 07/2018/TT-BYT — pharmacovigilance obligations of MA holders.

Note on numbering: Circular numbers and effective dates should always be verified against the official publication on the DAV portal or the Official Gazette (Công báo) before relying on them for regulatory submissions.

This section combines the official regulatory changes with what they actually mean for sponsors and regulatory affairs teams operating in Vietnam. Read top-to-bottom for the chronological re-engineering of the registration process.

1) Registration categories and pathways (current state):

• New chemical entity (thuốc mới) — first-time MA for a never-before-registered active substance in Vietnam. Requires Module 4 (non-clinical) and Module 5 (clinical) of the ACTD/ICH-CTD plus full pharmacovigilance plan.
• Generic (thuốc generic) — abbreviated pathway via bioequivalence study against the Vietnamese reference product. Module 4 and most of Module 5 are replaced by the BE report; quality (Module 3) is in full.
• Biological / biosimilar (sinh phẩm / sinh phẩm tương tự) — biosimilar pathway uses comparative quality, non-clinical, and clinical data against the Vietnam-registered reference biological.
• Vaccine (vắc-xin) — full quality, non-clinical, clinical dossier plus mandatory lot release through the National Institute for Control of Vaccines and Biologicals (NICVB).
• Herbal / traditional medicine (thuốc dược liệu / thuốc cổ truyền) — dedicated dossier structure with raw-material identification, standardisation, and traditional-use evidence.
• Pharmaceutical starting material (nguyên liệu làm thuốc) — registered under the same Circular 08/2022 framework, often with a CEP or DMF in lieu of full Module 3.S.
• Renewal (gia hạn) — separate procedure under Circular 08/2022 with shorter timelines on paper; submission window opens 12 months before expiry.

2) Step-by-step DAV process (under Circular 08/2022/TT-BYT):

• Step 0 — Pre-submission. Sponsor confirms it is eligible to hold an MA (Vietnamese legal entity OR foreign manufacturer with a registered Vietnam representative office), confirms the manufacturing site has a current GMP recognised by Vietnam, and obtains a Pharmaceutical Product Certificate (CPP) or Free Sale Certificate (FSC) plus other supporting documents.
• Step 1 — Online submission via dichvucong.dav.gov.vn. As of 2024 paper submissions are phased out; the dossier is uploaded module-by-module with a wet-signed and notarised cover letter set.
• Step 2 — Completeness (administrative) review by DAV: ~15 working days on paper. Pass → dossier is "received"; fail → applicant has 90 days to cure (or the file is closed).
• Step 3 — Technical evaluation by DAV expert groups (Quality, Non-clinical, Clinical, Bioequivalence, Labelling). Each module is reviewed in parallel by external academic experts contracted by DAV.
• Step 4 — Question rounds (yêu cầu bổ sung). The expert teams compile questions in batches. Applicant has 90 working days per round to respond. Two question rounds is typical; three signals risk of rejection.
• Step 5 — Advisory Council on Drug Registration (Hội đồng Tư vấn cấp giấy đăng ký lưu hành thuốc). The Council sits roughly monthly; cleared dossiers are tabled and voted on as a batch.
• Step 6 — DAV issues the giấy đăng ký lưu hành with the registration number (SĐK). The number is published on the DAV portal — at which point the product appears on Medibase's drug-registration search.
• Step 7 — Post-approval: variations (Type IA / IB / II) under Circular 08/2022 Article 39 and the annexes; pharmacovigilance reporting under Circular 07/2018; renewal at least 12 months before expiry.

3) Statutory timelines vs reality (the practice gap):

• On paper (Circular 08/2022): 12 months for a new drug, 9 months for a generic, 6 months for a renewal, 3 months for minor variations.
• In practice (2022–2024): new drug 24–36 months, generic 18–24 months, renewal 12–18 months. The gap is what triggered the 2023 emergency extension and the 2024 Pharmacy Law amendment.
• Post-amendment (from 1 July 2025): SRA-recognised products are targeted at 6–9 months under the new fast-track / reference-dossier pathway; the rest of the system still digests the legacy backlog. Practical recovery is expected to take 2026–2027.

4) The 2022–2024 backlog crisis (why the rules changed):

• Tens of thousands of MAs were due for renewal in 2022 with a deeply understaffed DAV. Renewal dossiers piled up; many products with valid safety profiles fell off the market because their MAs expired with no decision in hand.
• National Assembly Standing Committee Resolution 80/2023/QH15 (January 2023) extended the validity of in-process renewals through 31 December 2024 — the first nationwide temporary fix.
• The DAV implemented a staged batch-publication system, releasing extended MA lists every few weeks throughout 2023–2024.
• The structural fix is Law 44/2024/QH15 (effective 1 July 2025), which embeds automatic extension into the law itself when defined conditions are met.

5) The 2024–2025 reform package (what changed under Law 44/2024):

• Renewal: dossiers filed at least 3 months before expiry with a complete set of documents trigger automatic extension; DAV cannot let a product fall off-market while the file is in review.
• Reference dossier: explicit basis for relying on an SRA approval (US-FDA, EMA, PMDA, MHRA, Health Canada, TGA, Swissmedic). Reduces the workload for products already cleared by a top regulator.
• Innovative drug: dedicated pathway with parallel scientific advice and a target 6-month timeline.
• Pharmacy practice: online OTC retail formally allowed under conditions — relevant because every online-sold drug must still hold a current MA.
• Drug pricing: tighter declaration regime; coordination between DAV (MA) and the pricing function for newly registered products.

6) Practical pitfalls (the questions that most rejection cycles come from):

• CPP / FSC legalisation: a CPP from a non-SRA country must be consularised by the Vietnamese embassy; missing this is the single most common Step 2 failure.
• Bioequivalence site recognition: for generic dossiers, the BE study site must be on the DAV-recognised list OR be located in an SRA country. A BE study from a non-recognised site has no value.
• ASEAN ACTD vs ICH-CTD: Vietnam accepts both, but mixing module structures within one dossier is a recurring trigger for completeness-review failure.
• Labelling: Vietnamese language is mandatory under Circular 01/2018; the package insert (HDSD) must mirror the approved Summary of Product Characteristics one-to-one.
• Pharmacovigilance plan: required at submission for new chemical entities and biologicals — many sponsors still treat it as a post-approval document.
• Local representative for foreign manufacturers: the registration must list a Vietnamese representative office or a Vietnamese MA-holder partner. A bare distribution agreement is not enough.