12 September 2017

The ICH E11(R1) Addendum on Clinical Investigation of Medicinal Products in the Pediatric Population reached Step 4 of the ICH Process in August 2017 and now enters into the implementation period (Step 5). This Addendum is proposed to address new scientific and technical knowledge advances in pediatric drug development and update the ICH E11 Guideline adopted in 2000.

The ICH E11(R1) Addendum is available for download on the Efficacy Guideline page of the ICH website.