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May 27, 2025

Vietnam Issues New Regulations on Drug Registration

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On May 16, 2025, Vietnam’s Ministry of Health (MOH) issued Circular No. 12/2025/TT-BYT on registration of drugs and drug materials (Circular 12). Circular 12 will come into effect on July 1, 2025, replacing Circular No. 08/2022/TT-BYT (as amended), which provides the current regulations on drug registration, along with Circular No. 16/2023/TT-BYT on registration of drugs under toll manufacturing and technology transfer, and Circular No. 07/2017/TT promulgating the list of non-prescription drugs.

Some of the key stipulations of Circular 12 are outlined below.

Regulation of non-prescription drugs

Circular 12 abolishes the detailed list of over-the-counter (OTC) drugs previously stipulated in Circular No. 07/2017/TT-BYT. Instead of relying on a fixed list for classification, Circular 12 introduces a new framework based on principles, criteria, and specific methods for determining the status of non-prescription/OTC drugs. This approach aims to enhance safety, ensure timely access, reflect actual usage and supply conditions, and align with international standards.

Drugs that have already been approved will retain their classification (i.e., as prescription or non-prescription) throughout the validity of their marketing authorization (MA), and reclassification will be considered when the MA is renewed. If a change in classification is requested, the MA holder must submit a variation registration dossier to the Drug Administration of Vietnam (DAV).

For drug registration dossiers currently under evaluation by the DAV, the classification will be assessed in accordance with the new provisions set out in Circular 12.

Drug registration

The new regulations under Circular 12 loosen the requirements on providing a Certificate of Pharmaceutical Product (CPP). For all drug registration cases, a single CPP will suffice, provided it is issued by the competent authority of the manufacturing country or by an authority from a country that is a member of the European Medicines Agency (EMA) or a Stringent Regulatory Authority (SRA), and confirms that the drug is licensed and actively marketed in that country. Under the previous regulations, an additional CPP or similar legal document could be required in certain circumstances.

Regarding drug registration using the reference results of a registration dossier appraised by other authorities:

  • The registration dossier must be submitted in Vietnam within no more than five years from the date the drug is first approved by the EMA or SRA, as stated in the assessment report.
  • The registration dossier submitted in Vietnam must include (i) an assessment report issued by the EMA or SRA and (ii) a comparison table of the similarities between the drug registration dossier in Vietnam and the version approved by the EMA/SRA.

MA extension: Under the new regulations, extension dossiers may be submitted at any time prior to the expiry of the MA.

Timeline for supplemental dossiers: The deadline for submitting a supplemental registration dossier in response to a deficiency letter from the DAV is shortened to six months in all cases.

Limits on supplementation rounds: Normally, a maximum of two rounds of supplementation is permitted in response to requests from DAV experts. A third round is allowed only if additional requirements are raised during the second round. These limitations do not apply to supplementation requests issued by the Advisory Council for Drug Registration.

Outlook

Circular 12 will impact companies manufacturing and trading in drugs and drug materials in Vietnam. These companies are advised to review the new regulations thoroughly to ensure timely compliance with the amended provisions.

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