19 October 2016

In October 2016, the ICH endorsed a new topic for the development of a new multidisciplinary guideline to address Biopharmaceutics Classification System (BCS)-based biowaivers. This guideline will provide recommendations to support the biopharmaceutics classification of medicinal products and will provide recommendations to support the waiver of bioequivalence studies.

The M9 Concept Paper and Business Plan are now available for download on the ICH website under Multidisciplinary page.