Pediatric Study Plans (PSP & PIP)

PREA (Pediatric Research Equity Act) in the US requires sponsors to assess the safety and effectiveness of drugs in pediatric populations unless a waiver or deferral is granted. You submit an Initial Pediatric Study Plan (iPSP) before your End-of-Phase 2 meeting. In the EU, the Paediatric Regulation requires a Paediatric Investigation Plan (PIP) to be submitted and agreed upon before filing your Marketing Authorization Application. Both have the same goal but different timelines and negotiation processes.