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.