Loading...

產業新聞

Home / News

EU: ICH M9 to take effect in EU by end of July

2020/02/13  EMA

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.

To continue reading this article please go to EMAEMA ICH M9 Guideline on Biopharmaceutics Classification System-Based Biowaivers