Circular 32 takes effect on 1 October 2026 and introduces important changes to the preparation, assessment and management of marketing authorisation dossiers for drugs and drug substances in Vietnam.
On 29 July 2026, the Ministry of Health issued Circular 32/2026/TT-BYT (“Circular 32”) on the marketing authorisation of drugs and drug substances for human use. Circular 32 applies to chemical drugs, vaccines, biological products, herbal drugs and drug substances. It does not apply to traditional drugs or medicinal materials.
Circular 32 will replace Circular 12/2025/TT-BYT from 1 October 2026. Although the new rules introduce additional flexibility in several areas, they also place greater responsibility on registration establishments to substantiate their regulatory approach, classify changes correctly and maintain supporting records.
Key takeaways
- Consolidated applications and deferred submission of a Certificate of Pharmaceutical Product (CPP) are available only where all applicable conditions are met.
- An exemption from safety and efficacy documentation does not exempt the dossier as a whole from assessment or remove other applicable documentation requirements.
- A Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) should not be treated as standalone evidence of Good Manufacturing Practice (GMP) compliance.
- Pending applications should be assessed individually before a registration establishment requests the application of a more favourable transitional provision.
Transitional arrangements
In principle, applications submitted before 1 October 2026 but not yet determined will continue to be processed under the rules in force at the time of submission. From the effective date, a registration establishment may request the application of provisions of Circular 32 that facilitate or simplify administrative procedures, subject to the scope and conditions of the relevant transitional provisions.
This is not an unrestricted right to choose between the old and new regimes. Businesses should assess each pending application by reference to its submission date, current status and the specific provision proposed to be applied.
Five changes businesses should note
1. Application submission and supplementary CPPs
Circular 32 permits a single application to cover multiple products where the prescribed criteria are met. The scope is expanded in certain cases involving different packaging establishments or batch-release sites. The omission of certain criteria as separate items does not, however, create an automatic right to make a consolidated submission. The applicable conditions and consistency of each product must still be verified.
In the cases specifically prescribed by Circular 32, the Drug Administration of Vietnam may accept a new marketing authorisation application without a CPP. The registration establishment must provide a written explanation and submit the CPP no later than its second supplementary submission made at the request of the receiving authority.
This mechanism defers only the timing of CPP submission. A product will remain ineligible for marketing authorisation if the CPP is not submitted on time or does not satisfy the requirements concerning the issuing authority, contents, validity or consistency with the dossier.
What businesses should review: Identify applications that may qualify for deferred CPP submission and establish controls for the applicable deadline, issuing authority, validity and dossier consistency.
2. Safety and efficacy data and reliance mechanisms
Circular 32 continues the mechanism for relying on assessments by foreign medicines regulatory authorities and differentiates data requirements according to the characteristics of the product.
For a chemical drug having the same active ingredient, strength or concentration, route of administration and dosage form as a drug authorised by a reference stringent regulatory authority (SRA) or the European Medicines Agency (EMA), but with changes to its indication, dosage regimen, bioavailability or pharmacokinetics, Circular 32 permits an appropriate data pathway. Depending on the case, this may comprise full clinical data; literature data together with the package insert or summary of product characteristics; or data prepared under clinical development guidelines for drugs with new improvements.
A chemical drug similar to a drug authorised by an SRA or the EMA, and not falling within the above group of changed or improved drugs, may be exempt from submitting safety and efficacy documentation. Circular 32 also adds an exemption for certain newly domestically manufactured drugs for the prevention or treatment of Group A infectious diseases, excluding vaccines, where all prescribed conditions are satisfied.
An exemption from safety and efficacy documentation does not remove applicable administrative, quality or bioequivalence documentation requirements, nor does it exempt the dossier as a whole from assessment.
What businesses should review: Correctly classify the product and compare it with drugs authorised in Vietnam and by an SRA or the EMA before selecting the data package and reliance pathway.
3. Quality dossiers, CEP/GMP and registered drug substances
Compared with Circular 12, a CEP is no longer listed among the documents that may independently demonstrate a drug-substance manufacturer’s GMP compliance. A CEP may still form part of the quality dossier, but it should not be used as standalone GMP evidence. Dossiers currently using a CEP for both purposes should be reassessed, and any supplementary documents required under Article 22.7 of Circular 32 should be identified.
Circular 32 also addresses electronic quality documents. Where documents in the drug-substance section are provided electronically without the drug-substance manufacturer’s seal, they may be certified with the seal of the finished-product manufacturer or the registration establishment. The certifying party assumes legal responsibility for their accuracy, lawfulness and authenticity.
Where a drug substance already holds a marketing authorisation in Vietnam and is used in accordance with its approved name, manufacturer, quality standard and source, the finished-product dossier need not resubmit certain listed quality documents and legal papers. This is a limited exemption from resubmission, not permission to rely on or reuse the entire drug-substance dossier. Two certificates of analysis must still be submitted as required.
What businesses should review: Reassess dossiers that rely on a CEP as GMP evidence and confirm whether a registered drug substance meets every condition for the limited exemption from resubmission.
4. Contract manufacturing, technology transfer and stability data
Circular 32 removes from the required dossier the permit for contract manufacturing for foreign traders under Decree 69/2018/ND-CP. It also clarifies the requirement to align changes to the formulation, manufacturing process, material specifications, finished-product specifications and trade name of a contract-manufactured drug or a drug prior to technology transfer.
For certain contract-manufacturing or technology-transfer applications, or new applications involving a change of manufacturer, Circular 32 permits the use of at least six months of long-term and accelerated stability data where all conditions are met. Stability studies must continue after authorisation, and any out-of-specification result must be reported together with remedial measures.
What businesses should review: Control stability data, variation filing deadlines and any separate notification obligations for contract-manufactured or technology-transferred drugs as an integrated workstream.
5. Post-approval changes and reconsideration
Appendix II increases the categories of minor notification-only changes from 11 to 13. The new categories include:
- MiV-N11: a minor change to the manufacturing process of certain drugs, provided it qualifies as a Level 1 change under the US Food and Drug Administration’s Scale-Up and Post-Approval Changes (SUPAC) guidance and satisfies all technical conditions;
- MiV-N12: a change to a component of the primary packaging that does not directly contact the finished drug and does not affect dose delivery, use, safety or stability; and
- MiV-N13: a change to the name or address of the establishment or party responsible for quality testing, where the manufacturer and testing site remain unchanged.
The notification mechanism may be used only when every condition for the relevant variation code is satisfied. Otherwise, the applicable approval procedure must still be followed.
An approved change must be implemented within 12 months. A notification-only change may be implemented from the date the dossier is received, but no later than 12 months after publication by the Drug Administration of Vietnam. The continued circulation of products bearing the previous particulars depends on the date of domestic manufacture or, for imported drugs, the shipment date at the port of departure.
Circular 32 also allows a registration establishment to request reconsideration within one month after receiving notice that an application will not be granted or renewed, or that a variation will not be approved. If the explanation is accepted under the prescribed process, assessment may continue without the establishment having to repeat the entire procedure from the beginning.
What businesses should review: Revalidate the classification of proposed notification-only changes and establish a calendar for implementation, manufacture or shipment cut-off dates and the one-month reconsideration period.
Actions to take before 1 October 2026
Businesses should consider taking the following steps:
- Map the dossier portfolio. Classify applications being prepared, submitted, supplemented or awaiting renewal, together with post-approval changes, and record the intended transitional approach for each.
- Review CPP and CEP/GMP documentation. Identify deferred CPP cases and reassess applications that previously relied on a CEP as GMP evidence.
- Confirm the data strategy. Compare the proposed product with drugs authorised in Vietnam and by an SRA or the EMA to determine the correct safety and efficacy data package.
- Assess drug-substance dossiers. Confirm eligibility for the limited exemption from resubmitting specified documents and prepare the two required certificates of analysis.
- Review stability data and post-approval changes. Focus on contract manufacturing, technology transfer, manufacturer changes and proposed MiV-N11, MiV-N12 or MiV-N13 changes.
- Establish a regulatory calendar. Track submission and implementation deadlines, manufacture or shipment cut-off dates and the period for requesting reconsideration.
ALIAT’s view
Circular 32 provides useful procedural flexibility, but its practical benefit will depend on careful product classification and well-supported regulatory decisions. Updating dossier checklists alone will not be sufficient. Registration establishments should also review their internal processes for variation classification, deadline management, approval of notification-only changes and documentation of any request to apply a transitional provision.
Circular 32/2026/TT-BYT dated 29 July 2026 takes effect on 1 October 2026 and replaces Circular 12/2025/TT-BYT.
This update provides general information as at the date of publication and does not constitute legal advice or regulatory advice on any specific product or dossier. Application of the rules should be assessed in light of the dossier status, product characteristics and implementing guidance issued by the competent authorities.