EMA Seeks Comments on Guidelines for Neonate Products

The European Medicines Agency (EMA) is considering revisions to its guidance for sponsors of medicines for neonates and is seeking input from stakeholders by Dec. 16.

The category is defined in the current guideline as children from birth to age 27 days, but the agency invited comments on whether it should be updated to include the modern definition for preterm neonates. “In accordance with the most precise definition, the neonatal age for preterm neonates is considered the age period up to 44 full weeks of [postmenstrual age],” the agency said.

The EMA also suggested that the guidelines be revised to include specific suggestions on non-clinical models of neonatal conditions, the evaluation of short- and long-term safety, ways to demonstrate medicinal efficacy and the use of available tools and biomarkers.