ICH M9 on biopharmaceutics classification system based biowaivers - Scientific guideline
Table of contents
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.
Keywords: Bioequivalence study exemptions, solubility, permeability, in vitro dissolution
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ICH M9 on biopharmaceutics classification system based biowaivers - Step 5 (PDF/361.63 KB)
Adopted
First published: 11/02/2020
Legal effective date: 30/07/2020
EMA/CHMP/ICH/493213/2018 -
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ICH M9 on biopharmaceutics classification system based biowaivers - Step 5 - Questions and answers (PDF/401.1 KB)
First published: 11/02/2020
EMA/CHMP/ICH/10044/2020
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ICH M9 on biopharmaceutics classification system based biowaivers - Step 2b - First version (PDF/351.95 KB)
Draft: consultation closed
First published: 06/08/2018
Last updated: 06/08/2018
Consultation dates: 06/08/2018 to 06/02/2019
EMA/CHMP/ICH/493213/2018 -
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Overview of comments received on ICH guideline M9 on biopharmaceutics classification system based biowavers (EMA/CHMP/ICH/493213/2018) (PDF/438.91 KB)
Adopted
First published: 22/02/2019
EMA/118938/2019