Investigation of medicinal products in the term and preterm neonate

  • Email
  • Help
Current effective version

Adopted guideline

Currently under revision - see below 

Reference numberEMEA/536810/08
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

Concept paperPublished: 17/09/2018 
Deadline for comments: 16/12/2018

First version

Current version

Adopted guideline

Overview of comments

Draft guideline

In operation: 01/01/2010–present

Published: 25/06/2009

Published: 01/10/2007

Related content

How helpful is this page?

Average rating:

 Based on 25 ratings

Add your rating:

See all ratings
5 ratings
5 ratings
5 ratings
5 ratings
5 ratings

Tell us more