Drug Registration

On May 16, 2025, the Ministry of Health (MOH) of Vietnam issued Circular No. 12/2025/TT-BYT on registration of drugs and drug materials (“Circular 12”).  

Non-prescription drugs  Circular 12 abolishes the detailed list of over-the-counter (OTC) drugs previously stipulated. 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. 

Registration of drugs in Vietnam   Circular 12 loosens the requirements on a Certificate of Pharmaceutical Product (the “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 (the “EMA”) or a Stringent Regulatory Authority (the “SRA”), and confirms that the drug is licensed and actively marketed in that country. 

  In order to use  the registration dossier appraised by other authorities as the reference results, 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 the SRA, as stated in the assessment report, and the accompanying documents must be submitted.   The deadline for submitting a supplemental registration dossier for the deficiency letter from the he Vietnam Drug Administration Agency is shortened to six months in all cases. 

Normally, a maximum of two rounds of supplementation is permitted in response to requests from the Vietnam Drug Administration Agency. A third round is allowed only if additional requirements are raised during the 2nd round. These limitations do not apply to supplementation requests issued by the Advisory Council for Drug Registration. 

Circular 12 will come into effect on 1st July 2025 and replace the current regulations on drug registration.