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blue-check New regulations on drugs subject to bioequivalence study during application for marketing authorization

Circular No. 07/2022/TT-BYT dated September 5th, 2022 of the Minister of Health on pharmaceutical products for which in vivo bioequivalence studies are required and requirements for documentation of bioequivalence study reporting during application for marketing authorization of these pharmaceutical products in Vietnam
Posted: 6/9/2022 10:03:20 AM | Latest updated: 26/9/2022 11:13:14 AM (GMT+7) | LuatVietnam: 5536 | Vietlaw: 579
VietlawOnline

This Circular provides for generic drugs subject to bioequivalence study reporting and documentation of bioequivalence study reporting during application for marketing authorization in Vietnam.

“In vivo bioequivalence study” means a clinical study undertaken on a volunteer and designed to compare the bioavailability of a generic drug with a comparator product with the aim of demonstrating the interchangeability of generic drugs to replace comparator products.

Accordingly, during application for marketing authorization of the generic drugs that contain active pharmaceutical ingredients included in the List prescribed in Appendix I issued together with this Circular, it is required to make a bioequivalence study report.

With regard to generic drugs in dosage form, reports on bioequivalence study data are required upon applying for marketing authorization include if they are: (i) immediate release pharmaceutical products with systemic action, which contain active pharmaceutical ingredients specified in Clause 2 Article 3 of this Circular or (ii) modified release pharmaceutical products with systemic action.

This Circular takes effect from November 1st, 2022 and replaces Circular No. 08/2010/TT-BYTstatus1 dated April 26th, 2010.

Notes
Please be informed that the attachments are neither translated nor included in the English file.
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Effective Date 1-Nov-2022
ExpiredDate Unknown
Published Vietlaw's Newsletter No. 579

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