Europe – Actions to support the development of medicines for children

Regulators in the European Union (EU) have taken several initiatives in the past four years to increase the efficiency of paediatric regulatory processes and boost the development of medicines for children. These achievements are highlighted in the PDF icon closing report of the EMA and European Commission (EC) action plan on paediatrics .

Some of the key improvements brought by the paediatric action plan include:

  • Strengthened focus on unmet medical needs: over the last four years, EMA and relevant stakeholders systematically got together to better identify and raise awareness on the areas where medicines for children are particularly needed, with a goal to shift the research agenda to these areas. For example, multi-stakeholder strategy fora to discuss and agree the needs of children with cancer, and of children with inflammatory bowel disease have taken place. The learnings from these meetings involving clinicians, paediatric patients and their representatives, academia, regulators, HTAs bodies, and developers are being taken into account by EMA when discussing paediatric investigation plans (PIPs) for new medicines…