31 August 2018

The ICH M9 draft Guideline on Biopharmaceutics Classification System-based Biowaivers reached Step 2b of the ICH Process in June 2018 and has entered the public consultation period. Additionally, a Step 2 Presentation has been developed by the Expert Working Group.

Further information can be found on the M9 page, including the Step 2 Presentation for download.