Background: The EU Paediatric Regulation was introduced in 2007. In the United States, specific paediatric legislation has existed for even longer. This overview describes the similarities and differences in the legislation and provides input on how to achieve a global, harmonized pediatric development plan.
Objectives: The overview aims to investigate, through discussions and case examples, how to achieve pediatric medicines development fulfilling the expectations of the authorities as well as sponsors.
Methods: The pediatric legislation used in the European Union and United States are compared, and case studies for pediatric development plans where a global harmonized plan was eventually achieved are discussed.
Results: The case studies demonstrate some difficulties in getting to the goal of globally aligned pediatric plan development; however, recent initiatives from EMA and FDA are to a large degree addressing such challenges.
Conclusions: Global pediatric drug development is a evolving field, and with recent initiatives from the European Medicines Agency and US Food and Drug Administration, this goal is definitively attainable. (Curr Ther Res Clin Exp. 2019; 80:XXX-XXX).
Keywords: European Medicines Agency; Food and Drug Administration; Globally aligned pediatric drug development; Paediatric Investigation Plan; Pediatric study plan; Pediatrics.