This document provides guidance on the pharmaceutical development of medicinal products for children between birth and 18 years of age.

Keywords: Pharmaceutical development, quality, child, paediatric formulation, paediatric investigation plan (PIP)

Current effective version

Guideline on pharmaceutical development of medicines for paediatric use

Document history - Revision 2

Guideline on pharmaceutical development of medicines for paediatric use

Document history - Revision 1

Overview of comments on 'guideline on pharmaceutical development of medicines for paediatric use' received during the second public consultation

Draft guideline on pharmaceutical development of medicines for paediatric use

Document history - First version

Overview of comments received on 'guideline on pharmaceutical development of medicines for paediatric use' (EMA/CHMP/QWP/180157/2011)

Draft guideline on pharmaceutical development of medicines for paediatric use

Concept paper on the development of a quality guideline on pharmaceutical development of medicines for paediatric use

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