03 Sep, 2018
The European Medicines Agency (EMA) has published a brief history of their support of paediatric research. Here it is a glance:
Children react differently to medicines than adults, which is why it is important that medicines are properly studied and demonstrated to be safe and effective for minors.
Further to the introduction of the Paediatric Regulation in the European Union (EU) in 2007, manufacturers are required to consider children’s therapeutic needs when researching and developing medicines. This regulation also created the European Medicines Agency’s (EMA) Paediatric Committee (PDCO) that is responsible for reviewing paediatric investigation plans (PIPs).
The Paediatric Regulation has raised awareness of the need to study medicines in children, and paediatric research is now standard practice in the development of medicines.
Between 2007 and 2017, more than 200 medicines for children were authorised. This accounts for 25% of all new medicines authorised for marketing in the EU.
EMA also runs the European Network of Paediatric Research (Enpr-EMA), a network of research networks, investigators and centres with recognised expertise in clinical studies with children.