OBJECTIVES: Pediatric Investigation Plans (PIPs) were introduced by the European Commission in January 2007 to help ensure that medicines for children are included in the mainstream drug development process in Europe. The objective of this study was to review all authorized products by the European Medicines Agency (EMA) from 1995 to 2011 to identify (1) products with a potential pediatric indication, and (2) products with a PIP application. METHODS: On the EMA website, the European Public Assessment Reports (EPARs) were searched manually. For each product, the Summary of Product Characteristics (SmPC) was reviewed to explore quotes relative to any potential pediatric indication. The products were distributed in four categories: C1=adult indication only; C2=safety/efficacy not studied in children; C3=adult and pediatric indication; and C4=pediatric indication only. For each product, the EMA pediatrics database was searched for PIP applications. RESULTS: A total of 633 products were authorized by the EMA (281 in 1995-2006 and 352 in 2007-2011). From 1995 to 2006, 33.53% of the authorized products presented a lack of evidence in the pediatric population as did 57% in the period of 2007-2011. In total, 746 PIP applications were identified (products authorized and under development). A PIP was requested for 21.4% of the products authorized before the regulation (1995-2006) and for 19% of the products authorized after the EU pediatric regulation. CONCLUSIONS: The categorization of authorized products according to the SmPC quotes showed that many products had potential pediatric indications needing confirmation through new research programs. As expected, most of the PIP applications concern products under development. However, it is interesting to note that 20% of the requests concern authorized products, with a higher percentage of requests for products authorized before the regulation. These findings suggest that the pediatric regulation in Europe is fostering research to create more therapeutic options for children.