The 2017 Commission Report on the Paediatric Regulation
The 2006 Paediatric Regulation aims to address a gap in knowledge on how medicine should best be used by children. At the time of adoption of the Regulation, many products administered to children were still prescribed by doctors based on experience (off-label) rather than on the results of targeted paediatric clinical research. The Regulation intends to reduce the level of off-label use and increase the number of medicines specifically developed and tested for children.
