Pediatric Drug Development: Trends in the EU

Pediatric medicine has historically been overlooked by pharmaceutical companies due to low financial incentives compared to the high research and development investment required. Consequently, it is estimated that more than 50% of medicines used in children in the European Union have not been studied in pediatric populations. The 2007 Paediatric Regulation (EC No. 1901/2006) was implemented by the European Medicines Agency (EMA) to improve children’s health by facilitating the development and availability of new medicines for infants to 17-year-olds. This regulation established the Paediatric Committee (PDCO) to coordinate the EMA’s efforts, significantly changing the regulatory environment for pediatric medicines in the EU. 

In this paper, we discuss: 

• Pediatric Investigation Plans (PIPs), including rewards, incentives and mandates 
• The Commission’s 10-year report on the impact of the Regulation and recent trends in pediatric medicine approvals
• Challenges and solutions in conducting pediatric studies