18 October 2018

The ICH S11 draft Guideline on Nonclinical Safety Testing in Support of Development of Paediatric Medicines reached Step 2b of the ICH Process in September 2018 and now enters the consultation period. Additionally, a Step 2 Informational Presentation has also been developed by the Expert Working Group.

Further information can be found on the S11 page, including the Step 2 Informational Presentation for download.