The drug registration process in Vietnam will be simplified, particularly for foreign applicants, following the recent issuance by Vietnam’s Ministry of Health (MOH) of a new circular that is expected to reduce administrative hurdles. Circular No. 32/2026/TT-BYT on the registration of drugs and medicinal ingredients (Circular 32) was issued on July 29, 2026, and will take effect on October 1, 2026, replacing Circular No. 12/2025/TT-BYT.
Key provisions of the new circular are discussed below.
Five-Year Data Exclusivity and Five-Month Public Disclosure Framework
Circular 32 updates data protection guidelines by explicitly referencing Article 128 of the amended Intellectual Property Law, which sets out that new drugs supported by clinical trial data submitted for the first time will be granted a five-year data exclusivity period from the date of the initial marketing authorization (MA) approval. Subsequent applications that rely on the originator’s protected data will not be eligible for approval from the date of submission of the originator’s registration dossier until five years after the first MA is granted.
Furthermore, in accordance with the new regulations, the regulatory authority must publicly disclose information on subsequent applications five months before the granting of MA, providing originator companies with an opportunity to exercise and enforce their intellectual property rights.
Simplified Requirements for Foreign Legal Documents
Circular 32 expands the circumstances under which legal documents issued by foreign authorities are exempt from consular legalization and authenticity verification requirements. Specifically, such documents may be exempt if the Drug Administration of Vietnam (DAV) is able to verify their authenticity directly through official electronic means, including written confirmation or email correspondence sent directly to the MOH by the competent foreign authority, or publicly accessible English-language databases maintained by recognized foreign regulatory authorities.
In addition, the new circular permits the submission of electronic notarized copies of legal documents in registration dossiers as an alternative to hard-copy notarized documents.
Detailed Regulations on CEPs
Circular 32 provides more detailed requirements regarding the submission of electronic CEPs (“certification of suitability to the monographs of the European Pharmacopoeia”) within quality dossiers.
- For CEPs issued prior to September 1, 2023: The CEP must bear the official stamp/confirmation of the finished product manufacturer or applicant, and the CEP authorization section must explicitly list the authorized applicant or manufacturer.
- For CEPs issued from September 1, 2023, onward: A valid electronic CEP bearing an EDQM (European Directorate for the Quality of Medicines & HealthCare) digital signature, accompanied by an authorization letter must be submitted.
Applicants must also provide the results of a self-search conducted in the EDQM database, including mandatory information such as name of medicinal ingredient, CEP holder information, monograph number, and validity status.
Flexibility and Deferral of CPP Submissions
For new drugs and certain specified cases, applicants may postpone submission of a Certificate of Pharmaceutical Product (CPP) at the time of initial dossier filing by providing a written justification explaining its absence. However, the CPP must be submitted no later than the second round of dossier supplementation in order for the application to remain eligible for MA approval.
Exemption from Legal Documents for Pharmaceutical Ingredients with Granted MA
Where a finished product uses pharmaceutical ingredients that have already been granted MA in Vietnam, and strictly complies with the approved information (including ingredient name, manufacturer, specifications, and source), applicants are exempt from submitting legal documents demonstrating GMP compliance for ingredient manufacturers.
The applicant only needs to submit two certificates of analysis (COAs) for the ingredient—one issued by the ingredient manufacturer and one issued by the finished product manufacturer.
Detailed Implementation Rules for Post-Approval Variations
Under Circular 32, minor variations requiring notification (MiV-N) may be implemented immediately upon receipt of the notification dossier by the DAV or, at the latest, within 12 months from the date of public disclosure of the variation.
For imported drugs and medicinal ingredients, products may continue to be imported and circulated until their expiry date, provided they were dispatched from the port of export before the mandatory implementation deadline.
New Re-examination Pathway
Upon receiving an official refusal decision for a new registration, renewal, or variation application, applicants will have one month to submit a written explanation requesting reconsideration. If the explanation is accepted by the Advisory Council for granting MA or designated experts, the application may be approved directly without requiring the applicant to prepare and submit a completely new dossier. This new re-examination mechanism is expected to reduce the administrative burden, shorten approval timelines, and improve overall regulatory efficiency.
Next Steps
Pharmaceutical companies should review the new provisions for any potential impacts on current and future registration strategies to ensure timely compliance ahead of the circular’s effective date of October 1, 2026.
