ICH M9 on biopharmaceutics classification system based biowaivers - Step 2b - First version

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Download document ICH M9 on biopharmaceutics classification system based biowaivers - Step 2b - First version
Reference number EMA/CHMP/ICH/493213/2018
Status draft: consultation open
First published 2018-08-06
Last updated 2018-08-06
Consultation start date 2018-08-06
Consultation end date 2019-02-06
Email address for submissions ich@ema.europa.eu

Summary

This new multidisciplinary guideline is proposed to address biopharmaceutics classification system (BCS)-based biowaivers. BCS-based biowaivers may be applicable to BCS Class I and III drugs, however BCS-based biowaivers for these two classes are not recognized worldwide. This means that pharmaceutical companies have to follow different approaches in the different regions. This guideline will provide recommendations to support the biopharmaceutics classification of medicinal products and will provide recommendations to support the waiver of bioequivalence studies. This will result in the harmonisation of current regional guidelines/guidance and support streamlined global drug development.