This 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.

Keywords: Neonate, clinical trials, ethics, adverse effects, maturation, immaturity

Current version

Guideline on the investigation of medicinal products in the term and preterm neonate - First version

Document history - Revision 1

Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1

Overview of comments received during the public consultation on 'Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate' (EMA/PDCO/362462/2016) - Revision 1

Draft concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1

Document history - First version

Guideline on the investigation of medicinal products in the term and preterm neonate - First version

Overview of comments received on draft guideline on the investigation of medicinal products in the term and preterm neonates (EMEA/267484/2007) - First version

Draft guideline on the investigation of medicinal products in the term and preterm neonate - First version

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