The EU paediatric regulation: effects on paediatric psychopharmacology in Europe

European Neuropsychopharmacology : the Journal of the European College of Neuropsychopharmacology
Violeta V Stoyanova-BeninskaChristine Gispen-de Wied

Abstract

Child and adolescent psychiatry is a relatively young field and the recognition, classification, and treatment of disorders in children and adolescents lag behind those in adults. In recent years there is an increasing awareness of the differences between children and adults in psychopathology and pharmacology. Related to this new paediatric regulations have been introduced. This article reviews the regulatory and legislative measures that were adopted in the EU in 2007 and the subsequent impact of these measures on the field of paediatric psychopharmacology. The consequences of the paediatric regulation in the EU are reflected in several domains: regulatory, research aimed at drug development and clinical practices. In the regulatory domain, the consequences include: new paediatric indications, inclusion of special (class) warnings, specification of dose regimens, and information on safety specific to children and adolescents, and development of new medicinal formulations. The paediatric regulation leads to timely development of paediatric friendly formulations and better quality of the clinical evidence. In clinical practices, an increased awareness of the uniqueness of paediatric pharmacology is emerging among medical profes...Continue Reading

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Citations

Jan 20, 2012·Expert Opinion on Drug Delivery·Alejandro SosnikDiego A Chiappetta
Jun 15, 2011·European Neuropsychopharmacology : the Journal of the European College of Neuropsychopharmacology·Celso Arango
May 16, 2015·Drug Discovery Today·Joris LangedijkMarie-Hélène D B Schutjens
Mar 25, 2015·European Neuropsychopharmacology : the Journal of the European College of Neuropsychopharmacology·Mark J MillanSven Ove Ögren
Apr 4, 2015·European Neuropsychopharmacology : the Journal of the European College of Neuropsychopharmacology·Mark J MillanSven Ove Ögren
Nov 30, 2014·European Neuropsychopharmacology : the Journal of the European College of Neuropsychopharmacology·Celso Arango
Feb 22, 2014·Advanced Drug Delivery Reviews·M A TurnerUNKNOWN Global Research in Paediatrics
May 14, 2014·Advanced Drug Delivery Reviews·Alejandro Sosnik, Angel M Carcaboso
Jan 12, 2017·Paediatric Drugs·Gueorgui DubrocqB Ryan Phelps
Mar 31, 2021·European Neuropsychopharmacology : the Journal of the European College of Neuropsychopharmacology·C M Díaz-CanejaC Arango

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