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.
The Paediatric Regulation came into force in the EU in 2007 to encourage manufacturers to research and develop medicines for children’s specific therapeutic needs by using a system of rewards and obliging developers to specifically plan the development of their medicine for children (e.g. by integrating it into the development for adults) and submit a corresponding PIP.
A PIP is a development plan aimed at ensuring that the necessary data are obtained through studies in children, to support the authorisation of a medicine for paediatric patients. All applications for marketing authorisation for new medicines have to include the results of studies as described in an agreed PIP, unless the medicine is exempt because of a deferral or waiver.