Health Ministry amends drug registration rules

On April 20, Dr. Nguyen Tri Thuc, Deputy Minister of Health, chaired a meeting of the drafting team to develop a circular amending several articles of Circular No.12/2025/TT-BYT dated May 2025, regulating the registration for marketing authorisation of drugs and raw materials.

Dr. Nguyen Tri Thuc, Deputy Minister of Health, chaired the meeting. Photo: the MoH

Members of the drafting team flagged several areas in the circular for revision and clarification, including the Certificate of European Compliance; technical requirements for pharmaceutical raw materials to demonstrate compliance with standards recognised by the European Directorate for the Quality of Medicines & HealthCare; verification of manufacturing facilities using publicly available information on the EDQM website; and updates to stability data for technology-transferred drugs to ensure scientific and legal compliance.

For drugs that are not new, or whose active ingredient is already present in a licensed drug in Vietnam but differs in dosage or other parameters, clinical documentation may be exempted if the product has already been licensed in Europe and can be referenced.

Deputy Minister Nguyen Tri Thuc stated the necessity of amending and supplementing Circular No.12/2025/TT-BYT. This is because regulations on the registration of drugs and pharmaceutical raw materials play a crucial role in the healthcare management system of any country. It is not only an administrative procedure but also a technical barrier to ensure that products brought to market fully meet standards for quality, safety, and therapeutic efficacy.

Participants shared the ideas. Photo: The MoH

The deputy minister emphasised that the amendments should strengthen legal compliance, strict administrative and safety measures, and effectiveness, but also encourage the application of technology and accelerating digital transformation solutions in the comprehensive management and evaluation of drug dossiers, from ingredients and manufacturing processes to clinical data.

Following the meeting, the Drug Administration of Vietnam continued to gather feedback based on practical experience, in accordance with the Law on Pharmaceuticals, Decree No.63/ND-CP, and the direction of administrative procedure reform in drug registration and marketing authorisation.

He asked that the appendices need to ensure convenience for businesses, enhance transparency, post-inspection capabilities, and data retrieval.

MNCs wait for clear drug registration to get ahead While keeping strong business and investment plans in Vietnam, multinational corporations continue to seek more favourable timelines for innovative pharma registration to further facilitate future expansions.

Policy obstacles being addressed in drug licensing and renewal The Advisory Council for Drug Registration proposes addressing policy and institutional obstacles related to licensing and renewal of pharmaceuticals and vaccines to speed up the progress to facilitate business activities and increase the supply.