European Commission looks for feedback on pediatric regulation experience

The European Commission has launched a public consultation on the experience gained with the paediatric regulation. Until November 28, 2012 all interested citizens and public and private organizations are invited to send their contribution to this consultation to the European Commission.

The consultation builds on the European Medicines Agency’s Five-Year report to the Commission, ‘which reflects on the experience acquired as a result of the application of the Pediatric Regulation. The report summarizes the areas of success and lessons learned of the implementation of the Pediatric Regulation since 2007 when it came into operation.

Between 2008 to 2011, 13 new medicines as well as 30 new indications and nine new pharmaceutical forms of existing medicines were authorized for use in children; these authorizations were made on the basis of Pediatric Investigation Plans (PIPs) agreed by the Agency’s Pediatric Committee (PDCO).