European Medicines Agency resources 

Pediatric Regulation

The European Medicines Agency’s (EMA) Pediatric Regulation was implemented in 2007 with the aim of ensuring that medicines used in children are safe and effective and include appropriate labeling information. Read more

Pediatric Investigation Plans under the Paediatric Regulation

Pediatric Investigation Plans are developed in conjunction with pharmaceutical companies and outline a development plan to ensure necessary data are generated to support approval of the product for children. Read more

Pediatric Clinical Trials

This trial registry includes information on all clinical trials performed as part of a pediatric investigation plan or to support pediatric use of a medicine with EU marketing authorization.  Read more