Abstract

The European Union Pediatric legislation: impact on pharmaceutical research in pediatric populations

Author(s): Philippe Auby

The first European Paediatric Regulation came into force in the European Union on the 26 January 2007. A few years later, its impact on pharmaceutical research starts to be assessed from different perspectives. Such reflection process is quite valuable as it is anticipated that this regulation will be revised in a few years. Major achievements have occurred and have been acknowledged but there are also divergent opinions, and questions or concerns have been expressed, sometimes leading to interesting controversies. This article will review some background and key features of the European Paediatric Regulation and present, through the examples of pediatric psychopharmacology and oncology, its impact on pharmaceutical research with suggestions for future of pediatric research.