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