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

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Current effective version

Revision 1 - Adopted addendum

Revision 1 enters into effect  - see below

Reference numberEMA/CPMP/ICH/2711/1999
Effective from28/02/2017
KeywordsPaediatric medicinal product development, age categories, ethics, paediatric formulation, pharmacokinetic
DescriptionThis 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.

Document history

Revision 1


Adopted addendum


Overview of comments




Draft addendum

Published: 06/10/2017
Effective from: 28/02/2018


Updated: 28/04/2017




Published: 13/10/2016

First version

Current version

Adopted guideline

In operation: 21/01/2001-present



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