ICH M9 on biopharmaceutics classification system based biowaivers - Scientific guideline

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

Current version

ICH M9 on biopharmaceutics classification system based biowaivers - Step 5

AdoptedLegal effective date: 30/07/2020Reference Number: EMA/CHMP/ICH/493213/2018

ICH M9 on biopharmaceutics classification system based biowaivers - Step 5 - Questions and answers

Reference Number: EMA/CHMP/ICH/10044/2020

Document history

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

Consultation dates: 06/08/2018 to 06/02/2019Draft: consultation closedReference Number: EMA/CHMP/ICH/493213/2018Summary:

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.

Overview of comments received on ICH guideline M9 on biopharmaceutics classification system based biowavers (EMA/CHMP/ICH/493213/2018)

AdoptedReference Number: EMA/118938/2019