Investigation of medicinal products in the term and preterm neonate - Scientific guideline

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

Adopted Reference Number: EMEA/536810/2008 Legal effective date: 01/01/2010

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

Adopted Reference Number: EMA/PDCO/362462/2016 Summary:

Adopted concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate

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

Reference Number: EMA/139606/2019

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

Draft: consultation closed Consultation dates: 17/09/2018 to 16/12/2018 Reference Number: EMA/PDCO/362462/2016 Summary:

The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience of assessing PIP applications covering neonatal age subset has been gained since then and it has become apparent that some essential questions arise repeatedly during the assessment of Paediatric Investigation Plans (PIP) applications for products intended to be investigated and used in neonates. Furthermore, in recent years there has been increasing debate about neonatal research trends and standards, suggesting that the existing guidance even though approved only 5 years ago is not adequately addressing issues associated with the development and investigation of products in term and preterm neonates.

Document history - First version

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

Adopted Reference Number: EMEA/536810/2008 Legal effective date: 01/01/2010

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

Reference Number: EMEA/522641/2008

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

Draft: consultation closed Reference Number: EMEA/267484/2007