Europe – EMA and EC action plan on paediatrics

The EU’s regulatory framework for paediatric medicines, the Paediatric Regulation1, came into force in 2007. In 2017, the European Commission’s (EC) issued their ten-year reporton the implementation of the Regulation, which showed that the number of medicines developed for children increased during this period. However, it also revealed specific challenges, like developing medicines for diseases that only affect children or for diseases that manifest differently in adults and children. The report also highlighted that the development and later availability at patients’ bedside of paediatric medicines is often delayed when compared with adult medicines…