19 October 2016

The ICH E11(R1) draft Addendum Guideline on Clinical Investigation of Medicinal Products in the Pediatric Population reached Step 2b of the ICH Process in October 2016 and now enters the consultation period (Step 3). 

This Addendum is proposed to address new scientific and technical knowledge advances in pediatric drug development.

The draft E11(R1) draft Guideline is available for download on the Efficacy Guideline page on the ICH website. You are invited to provide comments on the draft E11(R1) draft Guideline by e-mailing the ICH Secretariat. More details under the Open Consultation page.

Note that stakeholders from EC, USA, Japan, Canada and Switzerland are encouraged to submit their comments to their respective Regulatory Authorities.