Pharmaceutical development of medicines for paediatric use

Current effective version

PDF iconRevision 2 - Adopted guideline

Reference number EMA/CHMP/QWP/805880/2012 Rev. 2
Published 31/07/2013
Effective from 15/02/2014
Keywords Pharmaceutical development, quality, child, paediatric formulation, paediatric investigation plan (PIP)
Description This document provides guidance on the pharmaceutical development of medicinal products for children between birth and 18 years of age.

Document history

Revision 2

Current version

PDF iconAdopted guideline

In operation: 15/02/2014–present

Revision 1

PDF iconOverview of comments


PDF iconDraft guideline - Rev. 1

Published: 31/07/2013


Published: 04/01/2013

First version

PDF iconOverview of comments


PDF iconDraft guideline


PDF iconConcept paper

Published: 04/01/2013


Published: 23/06/2011


Published: 29/07/2008

Related content

How useful was this page?

Add your rating
1 rating