Vietnam Ministry of Health Updates Guidance Report of Bioavailability/Bioequivalence for Drug Registration

This Circular is issued on 5 Sept 2022, effective on 1 Nov 2022, and replaced the current guideline Circular 08-2010/TT-BYT dated 26 Apr 2010. Vietnam Ministry of Health stipulates in the dossier that drug registration requires bioequivalent studies and research data.

According to Circular 07/2022/TT-BYT, the Ministry of Health has decided to widen the list of reference drug products for Bioequivalent studies, including approved brand-name products, and unapproved brand-name products that are being marketed across several countries. The drug registration applicants are also provided a list of criteria when selecting reference products. Additional criteria are provided in case brand-name products are not found.

Procedures, documents, forms, and templates of the Bioequivalent reports are described in detail to the applicant when registering for drug licenses in Vietnam

The Ministry of Health also gave a list of 26 Active ingredients contained in the generic product that will be required in bioequivalent study reports when registering drug licenses in Vietnam. This list will be evaluated and will be updated by the Ministry of Health.

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