title: Progress review of the European Paediatric Regulatory Framework after six years of implementation.
abstract: The EU regulation (EU 1901/2006 Paediatric Regulation) that entered into force in 2007 has changed the field of medicinal drug development for children in the EU. Five years after its implementation a large number changes due to this regulation have been incorporated by Pharmaceutical Industry considering the development of new candidate drug. This report is a review of changes already implemented and the aspects of paediatric drug development, which still needs to be addressed in future working in the fields to provide better medicines for children.
authors.affiliation: Paul-Ehrlich-Institut, Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel, Federal Institute for Vaccines and Biomedicines, Paul-Ehrlich-Str. 51-59, 1 63225 Langen, Germany. Electronic address: Dirk.Mentzer@pei.de.
authors.forename: Dirk
authors.initials: D
authors.lastname: Mentzer
mesh_terms: D002648:Child; D055808:Drug Discovery / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D005062:European Union; D033161:Government Regulation; D006801:Humans; D007880:Legislation, Drug; D010372:Pediatrics / Q000331:legislation & jurisprudence*
keywords: Authorisation; Clinical trials; Drug development; European regulation; Paediatric medicines