title: [Five years of European regulation on medication use in children: what has been achieved?].
abstract: It is not known if many existing medications can safely be used in children. For this reason the EU Paediatric Regulation came into force in 2007. When new medications are developed, pharmaceutical companies are obliged to produce a plan to research their use in children which must be approved by the regulatory authorities. Existing data on medications also had to be submitted. Review took place five years after the introduction of this regulation: of 682 medications, 476 plans were approved. In 206 of these medications this was unnecessary. By the end of 2011, research into 29 medications had been completed. The use of 10 of the 113 new, previously unregistered medications in children was approved, as was the case with 30 registered medications. Examination of existing data shows that results are often limited to changes in the 'Summary of Product Characteristics'. Many planned studies still have to be wound up, but in time the amount of information on safety and efficacy of new medications in children will increase greatly.
authors: College ter Beoordeling van Geneesmiddelen, Utrecht.
authors: Henk
authors: H
authors: van den Berg
authors: Aimad
authors: A
authors: Torqui
authors: Alfons I M
authors: AI
authors: Wesseling
mesh_terms: D035843:Biomedical Research / Q000331:legislation & jurisprudence / Q000592:standards*; D002648:Child; D064420:Drug-Related Side Effects and Adverse Reactions; D005060:Europe; D006801:Humans; D007880:Legislation, Drug; D010372:Pediatrics / Q000592:standards*; D055553:Prescription Drugs / Q000592:standards*; D018570:Risk Assessment
chemical_list: D055553:Prescription Drugs