The European Medicines Agency (EMA) and the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) have published today a joint action plan to support the development of medicines for children in Europe.
The action plan addresses challenges identified by the European Commission’s ten-year report on the implementation of the Paediatric Legislation. It also takes into account the ideas on how to better apply the Paediatric Regulation to boost the development of medicines for children collected during the multi-stakeholder workshop organised by EMA and the European Commission in March 2018.
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. PIPs are scientifically reviewed and agreed by the EMA’s Paediatric Committee (PDCO), which was also introduced by the same legislation.
Penta has been actively involved in the development of medicines for children since its establishment in 1991. So far, it has coordinated 8 large trials, with more than 2500 patients enrolled.