EMA introduces three new features for use in PRIME
The EMA has launched three new features in PRIME. These are intended to support and streamline continued scientific dialogue, give developers faster answers, and provide better support in preparation for the submission of a marketing authorisation application.
EMA review of stepwise paediatric investigation plan pilot
The European Medicines Agency (EMA) has published its review of the stepwise paediatric investigation plan (sPIP) pilot launched in 2023. The sPIP is intended to manage exceptional paediatric development programmes in which critical data are unavailable at the time of submission of initial Paediatric Investigation Plan (PIP), thereby constraining evidence-based planning of key study elements. The Report concluded that the stepwise approach demonstrated feasibility and value where it was used in exceptional cases.