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.


Posted on the EMA website on 17 September 2018