Paediatric Investigation Plans (PIP) Explained: Complete Regulatory Guide for EMA, FDA, and Global Submissions Paediatric Investigation Plans: Regulatory Strategies for Global Compliance and Drug Development Introduction to Paediatric Investigation Plans (PIP) A Paediatric Investigation Plan (PIP) is a comprehensive development program designed to ensure that medicines are appropriately studied in children. Introduced under the EU Paediatric Regulation (EC No 1901/2006), PIPs are mandatory for new medicines seeking marketing authorization in the European Union. Similar requirements exist in the US (FDA’s Pediatric Study Plan, PSP) and are emerging in India under CDSCO guidelines. The EMA’s Paediatric Committee (PDCO) reviews and approves…