Investigation of medicinal products in the term and preterm neonate

Current effective version

PDF iconAdopted guideline

Currently under revision - see below

Reference numberEMEA/536810/08
Published25/06/2009
Effective from01/01/2010
KeywordsNeonate, clinical trials, ethics, adverse effects, maturation, immaturity
DescriptionThis document addresses the considerations and requirements for the design and conduct of clinical trials in premature and term neonates using medicinal products of relevance for the use by this population. It includes background information on the maturation of organs and of body functions.


Document history

Revision 1

In progress

PDF iconConcept paper Published: 17/09/2018
Deadline for comments: 16/12/2018

First version

Current version

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline

In operation: 01/01/2010–present


Published: 25/06/2009


Published: 01/10/2007


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