Directive Inclusion of Bioequivalent Data in Dossiers for Product Registration
Dear Stakeholders and international partners, January 2025 Mandatory Inclusion of Bioequivalence Data in Dossier Submissions for Drug Products that do not Qualify for Biowaivers It has been discussed and made public at different meetings of manufacturers that the inclusion of Bioequivalence data in Dossier submissions will be mandatory from January 2025. Multisource pharmaceutical products (generic […]
