On May 16, 2025, the Ministry of Health of Vietnam (MOH) published Circular No. 12/2025/TT-BYT, which substantially changes the drug registration framework in Vietnam.
One key change entails the removal of the current fixed listing of over-the-counter (OTC) drugs. Instead, Circular 12 introduces a principles-based system for classifying non-prescription drugs. This system is intended to enhance access for patients, safety, and alignment with international practices. Current classifications will be valid until the marketing authorization (MA) is renewed; at which time it could be a good opportunity to assess the new classification system.
As a result of Circular 12, the requirements for a Certificate of Pharmaceutical Product (“CPP”) have also been relaxed. One CPP from the country of manufacture or a country that is recognized by the European Medicines Agency (“EMA”) or other Stringent Regulatory Authorities (“SRAs”) is sufficient for registration. According to Circular 12, a Vietnamese registration application must be submitted within 5 years from the date of product approval by an SRA or EMA.
The new regulations reduce the deadlines for supplemental dossiers to be submitted for regulatory deficiencies to six months. It also sets a limit to two rounds of supplemental dossiers, with a third round possible only if new issues arise during the second round.
Vietnam is changing its regulatory framework and is attempting to find a more efficient way to approve drugs by introducing these changes.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.