title: The EU-regulation on medicinal products for paediatric use: impacts on child and adolescent psychiatry and clinical research with minors.
abstract: BACKGROUND
  At present the EU-regulation on medicinal products for paediatric use is in the final legislation phase. The Regulation will bring essential changes to the policy of research with minors, to funding and to regulations of drug development in Europe.
  
  
  METHODS
  The article analyses contents of the regulation and possible effects on research with and treatment of mentally ill minors.
  
  
  RESULTS
  The regulation seems to be a chance to improve pharmacological treatment for children and bring similar research conditions to Europe as they already exist in the US. Some terms of the regulation must be considered as critical due to vague definitions and ambiguously defined policies in some articles. The designated expert committee will be a powerful institution, but it remains to be seen whether this committee will act in the intended way. It is an existing and real danger that European child and adolescent psychiatry will be neglected by the new regulation, if there is no participation of scientists of this discipline in committees. The regulation makes it necessary for child and adolescent psychiatry to strengthen research in clinical trials and developmental psychopharmacology to get benefits from new legislation and improve health care for mentally ill minors.
authors.affiliation: Dept. of Child and Adolescent Psychiatry/Psychotherapy, University of Ulm, Ulm, Germany. michael.koclch@uniklinik-ulm.cle
authors.forename: Michael
authors.initials: M
authors.lastname: Kölch
authors.forename: Kathlen
authors.initials: K
authors.lastname: Schnoor
authors.forename: Jörg M
authors.initials: JM
authors.lastname: Fegert
mesh_terms: D000293:Adolescent; D000296:Adolescent Psychiatry / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data; D026683:Advisory Committees / Q000706:statistics & numerical data; D035843:Biomedical Research / Q000706:statistics & numerical data; D002648:Child; D002665:Child Psychiatry / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000592:standards; D003431:Cross-Cultural Comparison; D003695:Delivery of Health Care / Q000331:legislation & jurisprudence; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence*; D005062:European Union / Q000706:statistics & numerical data; D006801:Humans; D007880:Legislation, Drug / Q000706:statistics & numerical data*; D001523:Mental Disorders / Q000188:drug therapy*; D033242:Minors / Q000331:legislation & jurisprudence; D012109:Research Support as Topic / Q000331:legislation & jurisprudence; D014481:United States