ICH E11(R1) step 5 guideline on clinical investigation of medicinal products in the pediatric population - Scientific guideline

This document provides an outline of critical issues in pediatric drug development and approaches to the safe, efficient, and ethical study of medicinal products in the pediatric population. The purpose of this addendum is to complement and provide clarification and current regulatory perspective on topics in pediatric drug development.

Keywords: Paediatric medicinal product development, age categories, ethics, paediatric formulation, pharmacokinetic

Current version

ICH E11(R1) guideline on clinical investigation of medicinal products in the pediatric population - Revision 1 (addendum)

AdoptedLegal effective date: 28/02/2018Reference Number: EMA/CPMP/ICH/2711/1999Summary:

The purpose of this addendum is to complement and provide clarification and current regulatory perspective on topics in pediatric drug development.

E 11: Clinical investigation of medicinal products in the paediatric population - Step 5

AdoptedLegal effective date: 01/01/2001Reference Number: CPMP/ICH/2711/99

Document history

ICH E11(R1) guideline on clinical investigation of medicinal products in the pediatric population - Revision 1 (addendum)

AdoptedLegal effective date: 28/02/2018Reference Number: EMA/CPMP/ICH/2711/1999Summary:

The purpose of this addendum is to complement and provide clarification and current regulatory perspective on topics in pediatric drug development.

Draft ICH E11(R1) guideline on clinical investigation of medicinal products in the pediatric population, step 2b - Revision 1

Consultation dates: 13/10/2016 to 13/04/2017Draft: consultation closedReference Number: EMA/CPMP/ICH/2711/1999Summary:

The purpose of the addendum is to complement and provide clarification and current regulatory perspective on topics in pediatric drug development. The use of the word “should” means that something is suggested or recommended, but not required, unless specific regulatory or statutory requirements are specified as advised by regulatory authorities worldwide.

Overview of comments received by EMA on the draft Addendum of the ‘ICH E11(R1) guideline on clinical investigation of medicinal products in the paediatric population’ (EMA/CPMP/ICH/2711/1999)

Reference Number: EMA/256626/2017 Corr.

E 11: Clinical investigation of medicinal products in the paediatric population - Step 5

AdoptedLegal effective date: 01/01/2001Reference Number: CPMP/ICH/2711/99