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

Term and preterm neonates represent the most vulnerable subgroup of the paediatric population with the highest rate of unauthorised or off-label used medicines across the entire paediatric population.

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 Paediatric Investigation Plans (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 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 is not adequately addressing issues associated with the development and investigation of products in term and preterm

Therefore it seems that there is a need to update currently available guidelines regarding the nonclinical and clinical development of medicinal products in neonates in accordance with current trends in neonatal terminology, and issues encountered and experience gained during assessment of PIP applications involving the neonatal population. Input will be sought from relevant working parties, committees and experts.

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