Availability of Pediatric Information In European Medicines Agency Approvals

Among 122 new medicines authorized by the EMA from 2010 to 2014 with pediatric study requirements, only 25% had pediatric safety or efficacy information at initial authorization, rising to 43% after a median follow-up of 4.8 years. While the EU’s 2007 Pediatric Regulation has contributed to meaningful additions of paediatric labeling information, 57% of medicines with requirements still lacked pediatric data after nearly 5 years, highlighting the need for additional measures to ensure timely completion of pediatric studies.