ICH M9 Step 2
The ICH guideline on Biopharmaceutics classification system-based biowaivers, ICH M9 is currently at step 2 (June 2018) and under public consultation.
Following JPAG's successful symposium on the ICH M9 topic (June 28th), JPAG are looking for specific comments from their members on these guidelines that will be subsequently forwarded to ICH.
The guidance is found HERE
This feedback item will remain open until 31st July 2018.