On May 16, 2025, the Ministry of Health promulgated Circular No. 12/2025/TT-BYT (“Circular 12”), governing the registration for marketing authorization (MA) of pharmaceutical products and active pharmaceutical ingredients (APIs) in Vietnam. Circular 12 officially supersedes Circular No. 08/2022/TT-BYT, Circular No. 16/2023/TT-BYT, and Circular No. 55/2024/TT-BYT.
Compared to the previous regulations, Circular 12 has simplified administrative procedures and provided greater clarity on specific regulatory requirements regarding registration dossiers and processes for MA. Key revisions introduced under Circular 12 are as follow:
Changes in documentation requirements and administrative procedures for MA registration
One key revision of Circular 12 compared to Circular No. 08/2022/TT-BYT, is the revised CPP requirement, as Circular 12 now allow submission of a single CPP from either the country of manufacture or an EMA/SRA country where the product is actually marketed, which enhances access to new drugs, vaccines and biologics. However, enterprise responsibilities are significantly reinforced. Specifically, the period for CPP authenticity verification is now extended to 03 years from the date of a regulatory sanction decision. Manufacturers and applicants bear full legal responsibility for the accuracy and legitimacy of their registration dossiers.
Regarding the MA renewal process, dossiers may now be submitted at any time prior to expiration date without a maximum time limit, enabling continuous market presence for strategic products. The new regulation also specifies that the product name may be changed during renewal. All other changes must be handled through corresponding variation dossiers. If a name change is approved upon MA renewal, this modification must be implemented no later than 12 months following approval.
Notably, to improve dossier quality, Circular 12 imposes stricter limits on dossier supplementation: a maximum of 02 rounds, each within 06 months, for initial registration, renewal, and variation. A third round is only permitted under exceptional circumstances, either at the request of evaluating experts (with Advisory Council approval) or from the Advisory Council itself. This emphasizes the need for careful preparation to ensure that the initial dossier is complete and consistent, with post-approval changes (if any) to be handled through appropriate variation or supplementation procedures.
Harmonization with international standards via reference assessment procedures and clinical data
Circular 12 have provide new regulation on reference assessment procedures, applied to drugs granted MA by EMA/SRA authorities, provided the Assessment Report is submitted within 05 years of the initial approval date. The Drug Administration of Vietnam (DAV) will verify technical document consistency with the reference dossier, and independently assess administrative and technical documents that differ. Assessment Reports from the EMA/SRA must be the official, final version, accompanied by any relevant decisions (if applicable), and must detail the evaluation of product quality, safety, and efficacy, along with the legal basis and scientific rationale for approval. At a minimum, these reports must cover administrative contents, quality, safety and efficacy data, together with a comparative equivalence table following Form 09/TT.
Clinical dossier requirements under Circular 12 also differ significantly from earlier regulations. Circular 12 mandates clinical data demonstrating safety and efficacy, sets clear exemption criteria for clinical trials or specific trial phases, and specifies cases requiring Phase IV trials. Circular 12 also outlines detailed clinical documentation requirements for new chemical drugs, vaccines, biologics, new non-innovator drugs (including first generics and super generics), and traditional or herbal medicinal products.
Delineation in authority to grant MA and shorten approval timelines
Circular 12 modifies the MA issue authority. Accordingly, the DAV will issue MAs following consultation with the Advisory Council for the following cases: newly authorized drugs within the 03 years; withdrawn products (voluntarily or by order); critical variations (e.g., ETC/OTC reclassification, changes to indications, dosage, administration route, and patient population); and the designation of innovator drugs, reference biological products, or submissions involving bioequivalence (BE) studies. Circular 12 then empowered the DAV to grant MAs directly, without Advisory Council consultation for products: that have held MA for 05 years; non-critical variation dossiers; and updates to the package insert to align with approved innovator drugs.
To ensure timely access to medicines and minimize MA approval delays, Circular 12 shortens dossier evaluation timelines: 12 months for new registrations; 9 months for new registrations via the reference pathway; 3 months for major variations and minor variations requiring prior approval; and just 20 working days for minor variations requiring notification only. For contract-manufactured (CM) or technology-transferred (TT) drugs, evaluation timelines are also encouraged to be shortened: no more than 3 months for drug products prior to contract manufacturing and drug products prior to technology transfer already granted an MA, and no more than 9 months for those without an existing MA.
Circular 12 contains several entirely novel provisions implemented for the first time, necessitating additional guidance from the DAV to ensure uniform application across the pharmaceutical sector. For enterprises, the new regulations under Circular 12 promise to simplify both the dossier requirements for obtaining MA as well as reducing the processing time. Therefore, proactively understanding and adapting to these significant changes in Circular 12 will be a key factor in maintaining a competitive advantage in the market. Circular 12 will take effect from July 1, 2025.
