Vietnam’s pharmaceutical market has grown steadily, supported by rising healthcare expenditure and increasing government investment in public health infrastructure. The Drug Administration of Vietnam (DAV), operating under the Ministry of Health (MoH), governs drug registration through Circular 08/2022/TT-BYT, which came into effect in mid-2022 and is now the primary instrument for foreign drug registration.
On the surface, Circular 08 looks manageable. It aligns in structure with CTD format, references international guidelines, and provides defined pathways and timelines. In practice, it is one of the more demanding registration frameworks in Southeast Asia, not because it is conceptually complex, but because the gap between the regulation’s text and what DAV expects in review is substantial. Manufacturers who approach Vietnam registration based on Circular 08 alone routinely face multiple deficiency rounds, extended timelines, and avoidable documentation failures.
What Circular 08 Governs and What It Replaced
Circular 08/2022/TT-BYT replaced the previous drug registration framework under Circular 32/2018/TT-BYT, introducing a number of structural changes to the registration dossier requirements, the pathway categorisation for foreign drugs, and the reference country recognition mechanism. It applies to registration of imported drugs, both innovative and generic, seeking a Marketing Authorisation Number (số đăng ký) from DAV.
Vietnam does not yet have a fully developed expedited or adaptive licensing pathway analogous to the FDA Breakthrough Therapy or EMA Conditional Marketing Authorisation. The standard registration pathway applies to most foreign drugs, with limited priority provisions for medicines addressing serious unmet medical needs as defined by the MoH.
All drug registrations in Vietnam are valid for five years, after which renewal is required. Renewals carry their own documentation obligations and are not automatically granted based on satisfactory original registration.
Reference Country Recognition Framework and Its Limits
Circular 08’s reference country recognition mechanism is a source of considerable misconception. The circular provides that drugs registered in MoH-recognised reference countries may qualify for an abridged dossier submission. Reference countries include ICH members, the US, EU member states, Japan, along with Australia, Canada, and several others.
The implication appears to be that FDA or EMA approval should significantly streamline Vietnamese registration. In practice, the simplification is less dramatic than sponsors anticipate. DAV’s abridged pathway reduces, but does not eliminate, documentation requirements. Applicants still must submit a complete Vietnamese Module 1 dossier, a Vietnamese-language clinical data summary, labelling adapted to local requirements, and a Certificate of Pharmaceutical Product (CPP) confirming active marketing, not merely approval, in the reference country. For products approved but not yet actively marketed in the reference country at the time of Vietnam filing, this creates an immediate eligibility question.
DAV also reviews the reference country’s approved indication and may not automatically accept its full scope. Where the clinical evidence is considered insufficient for the Vietnamese population context, the approved indication in Vietnam may be narrower than the reference approval.
Labelling and Vietnamese-Language Documentation Challenge
Labelling compliance is among the most consistently deficient elements of foreign drug registration in Vietnam. Circular 08 requires that all product labelling, inner label, outer label, and package insert be in Vietnamese, conform to MoH’s labelling regulation (Circular 01/2018/TT-BYT and its amendments), and reflect MoH-approved indication language.
The package insert must follow MoH’s defined content structure, which differs from FDA PI, EU SmPC, and most other jurisdictions’ formats, and must use Vietnamese regulatory terminology, not simply translated from the English label. Common deficiencies include indication language that mirrors the reference country label but does not conform to Vietnamese therapeutic terminology standards, missing or incorrectly formatted storage condition statements, and inclusion of claims or warnings that MoH has not approved for the Vietnamese market. Manufacturers who produce Vietnamese labelling through direct translation of reference country labelling without independent regulatory adaptation will encounter repeated DAV queries across review cycles.
GMP Documentation Burden
All manufacturing sites supplying Vietnam must demonstrate GMP compliance. Circular 08 accepts GMP certificates from recognised reference country authorities, EU GMP certificates, TGA GMP licences, and certificates from other recognised authorities. However, DAV has specific format and content expectations: certificates must be current, must explicitly identify the manufacturing site address and the scope of GMP coverage, and must be apostilled or notarised in a form DAV considers valid. DAV has rejected GMP documentation on the basis of apostille deficiencies, certificate scope ambiguities, and address discrepancies between the GMP certificate and the registration dossier.
For products manufactured across multiple sites, separate drug substance and drug product facilities, or contract manufacturing arrangements, GMP documentation must cover every site in the supply chain. Site changes after initial registration require a post-registration variation and updated GMP documentation.
DAV (Vietnam Drug Registration) Review Timelines
Circular 08 specifies a 12-month target review timeline for standard foreign drug registrations. In practice, effective timelines from submission to marketing authorisation number issuance have ranged from 18 to 36 months, and longer for complex products. The primary drivers are deficiency rounds triggered by documentation gaps, each of which pauses the review clock and DAV’s review capacity constraints relative to application volumes. Manufacturers who submit complete, well-organised dossiers with Vietnam-specific labelling, compliant GMP documentation, and accurate CPPs experience fewer deficiency rounds and remain closer to published targets.
Post-Registration Obligations and Variations
Vietnamese drug registration creates ongoing compliance obligations. Post-registration variations covering manufacturing changes, labelling updates, and indication modifications must be submitted to DAV for approval before implementation. Vietnam’s variation framework distinguishes between major variations requiring full prior approval and minor variations subject to notification, though the boundary between categories is not always clearly defined.
Pharmacovigilance obligations require registration holders to report serious adverse drug reactions to DAV and to submit periodic safety reports in accordance with MoH guidelines. The local responsible person, the Vietnamese entity accountable for the registered product, must manage these obligations from the date of marketing authorisation issuance, making the selection of a capable Vietnamese representative a substantive compliance decision.
Conclusion
Circular 08/2022/TT-BYT has provided Vietnam’s drug registration framework with a more structured foundation than its predecessor, but it has not simplified the registration process to the degree that international manufacturers sometimes expect. The reference country recognition mechanism reduces, but does not eliminate, documentation requirements; Vietnamese-language labelling must be purpose-built rather than translated, GMP documentation must meet specific DAV format expectations, and effective review timelines significantly exceed published targets. Manufacturers who approach Vietnam registration with a thorough understanding of DAV’s applied requirements, not just the circular’s text, are consistently better positioned for timely and successful registration outcomes.
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How can DDReg help?
DDReg provides specialist regulatory affairs support for pharmaceutical manufacturers seeking drug registration in Vietnam, including Circular 08 dossier preparation, Vietnamese-language labelling development, CPP and GMP documentation management, DAV submission coordination, and post-registration variation support across both innovative and generic product