In 2007, the Paediatric Regulation was adopted. The aim of the regulation was to address a serious gap in knowledge on how medicine should best be used by children. This was in part, due to the fact that a large number of products which were administered to children were prescribed based on experience (off-label) rather than on the results of clinical research. The Paediatric Regulation aimed to reduce the level of off-label use and increase the number of medicines specifically developed and tested for children.
To European Commission has released a consultation asking for feedback on it’s second report on paediatric regulation. This report is a ten-year report which highlights how paediatric medicine development has improved in the European medicines regulatory network over the last ten years but also highlights a number of the challenges to be addressed in this field.