title: The EU paediatric regulation: effects on paediatric psychopharmacology in Europe.
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 professionals, and subsequent improvement of medical care (i.e. correct doses, appropriate formulation, monitoring for expected adverse events). In addition, clinical guidelines will have to be revised more frequently in order to integrate the recently acquired knowledge. The new regulations stimulate transparency and discussions between academia, pharmaceutical industry, and regulators. The purpose is to optimize clinical research and obtain evidence for paediatric psychopharmacology, thereby providing adequate support for treatment.
authors.affiliation: Medicines Evaluation Board, The Hague, The Netherlands. v.stoyanova@cbg-meb.nl
authors.forename: Violeta V
authors.initials: VV
authors.lastname: Stoyanova-Beninska
authors.forename: Tamar
authors.initials: T
authors.lastname: Wohlfarth
authors.forename: Maria
authors.initials: M
authors.lastname: Isaac
authors.forename: Luuk J
authors.initials: LJ
authors.lastname: Kalverdijk
authors.forename: Henk
authors.initials: H
authors.lastname: van den Berg
authors.forename: Christine
authors.initials: C
authors.lastname: Gispen-de Wied
mesh_terms: D000293:Adolescent; D000296:Adolescent Psychiatry / Q000331:legislation & jurisprudence*; D002648:Child; D002665:Child Psychiatry / Q000331:legislation & jurisprudence*; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D005062:European Union; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D011364:Professional Practice; D011600:Psychopharmacology / Q000331:legislation & jurisprudence*