M9 Biopharmaceutics Classification System-based Biowaivers
This topic was endorsed by the ICH Assembly in October 2016.
This new multidisciplinary Guideline addresses 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 recognised worldwide. This means that pharmaceutical companies have to follow different approaches in the different regions.
This Guideline provides recommendations to support the biopharmaceutics classification of medicinal products and to support the waiver of bioequivalence studies.
This will result in the harmonisation of current regional guidance and support streamlined global drug development.
Date of Step 4: 20 November 2019
Status: Step 5
Guidelines (Click the links below for complete guidelines)
Endorsed Documents (Click the links below for complete guidelines)
WG Presentations / Trainings (Click the links below for complete guidelines)
M9 Q&As Q&As on Biopharmaceutics Classification System-based Biowaivers
The ICH M9 Q&As provide clarity to support the implementation of the ICH M9 Guideline on Biopharmaceutics Classification System (BCS)-based biowaivers in ICH Regulatory Member countries/regions.
Date of Step 4: 20 November 2019
Status: Step 5
Q&As (Click the links below for complete guidelines)
*These Guidelines Belongs to ICH website.
