Pharmaceutical development of medicines for paediatric use - Scientific guideline
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)
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Overview of comments on 'guideline on pharmaceutical development of medicines for paediatric use' received during the second public consultation (PDF/723.47 KB)
First published: 31/07/2013
Last updated: 31/07/2013
EMA/805826/2012 -
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Draft guideline on pharmaceutical development of medicines for paediatric use (PDF/234.78 KB)
Draft: consultation closed
First published: 04/01/2013
Last updated: 04/01/2013
Consultation dates: 04/01/2013 to 31/03/2013
EMA/CHMP/QWP/805880/2012 Rev. 1
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Overview of comments received on 'guideline on pharmaceutical development of medicines for paediatric use' (EMA/CHMP/QWP/180157/2011) (PDF/2.07 MB)
First published: 04/01/2013
Last updated: 04/01/2013
EMA/805826/2012 -
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Draft guideline on pharmaceutical development of medicines for paediatric use (PDF/247.13 KB)
Draft: consultation closed
First published: 23/06/2011
Last updated: 23/06/2011
Consultation dates: 01/05/2011 to 31/12/2011
EMA/CHMP/QWP/180157/2011 -
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Concept paper on the development of a quality guideline on pharmaceutical development of medicines for paediatric use (PDF/63.13 KB)
First published: 29/07/2008
Last updated: 29/07/2008
EMEA/138931/2008
