ICH E11(R1) step 5 guideline on clinical investigation of medicinal products in the pediatric population - Scientific guideline
Table of contents
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
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ICH E11(R1) guideline on clinical investigation of medicinal products in the pediatric population - Revision 1 (addendum) (PDF/285.08 KB)
Adopted
First published: 06/10/2017
Last updated: 06/10/2017
Legal effective date: 28/02/2018
EMA/CPMP/ICH/2711/1999 -
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Draft ICH E11(R1) guideline on clinical investigation of medicinal products in the pediatric population, step 2b - Revision 1 (PDF/279.26 KB)
Draft: consultation closed
First published: 13/10/2016
Last updated: 13/10/2016
Consultation dates: 13/10/2016 to 13/04/2017
EMA/CPMP/ICH/2711/1999 -
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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) (PDF/345.17 KB)
First published: 26/04/2017
Last updated: 28/04/2017
EMA/256626/2017 Corr. -
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International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: E 11: Clinical investigation of medicinal products in the paediatric population - Step 5 (PDF/156.9 KB)
Adopted
First published: 01/01/2001
Last updated: 01/01/2001
Legal effective date: 01/01/2001
CPMP/ICH/2711/99