TEDDY EPMD: A European Paediatric Medicines Database

Abstract

In line with European initiatives, TEDDY set up a new database, the European Paediatric Medicines Database, with the aim of creating a harmonised, integrated and reliable pan-European source of information. The data stored in the Database were the basis for examining the ‘state of the art’ of paediatric medicines licensed by the European Medicines Agency between October 1995 and December 2007. The results of the study show that 33% of medicinal products approved by the European Medicines Agency are intended for the paediatric population, and that this percentage has remained more or less constant in the 12 years of activity of the Agency. This trend is expected to increase rapidly in the future as a result of the adoption of the Paediatric Regulation. Nevertheless, it is essential that information on medicinal products for paediatric use are made publicly accessible and data should be verified and controllable. The European Medicines Agency has recently made public many information on medicines authorised in EU through the EudraPharm database. The TEDDY European Paediatric Medicines Database grants access also to information related to paediatric medicines, some of which are not available elsewhere. We deem this aspect a useful service to end users and a valid support to Regulatory Authorities.