title: [The new German drug market law AMNOG from a child and adolescent psychiatry perspective].
abstract: BACKGROUND
  The European Union (EU) regulation 1901/2006 plus the implementation of pediatric investigational plans by the European Medicines Agency (EMA) have contributed to more clinical studies in pediatric psychopharmacology. A new drug market law (AMNOG) has been in force in Germany since 2011 that requires an additional process of assessment of benefits of newly authorized medications by the Federal Joint Committee (Gemeinsamer Bundesausschuss, G‑BA), which also holds for medications licensed for pediatric populations.
  
  
  OBJECTIVE
  Summary of early assessments of benefits for newly registered compounds in the treatment of psychiatric disorders and critical discussion from the perspective of child and adolescent psychiatry.
  
  
  METHODS
  Application and critical review of documents and written statements by various institutions and stakeholders related to assessment procedures and respective decisions by the G‑BA for these medications.
  
  
  CONCLUSIONS
  Clearly differing requirements for study designs and outcome parameters characterize the conditions for market authorization and for the assessment of benefits. Further adjustments to the regulations in implementing the AMNOG appear to be essential, integrating agencies involved so far, complimented by expertise from regulatory agencies and medical scientific societies.
authors.affiliation: AG Klinische Psychopharmakologie des Kindes- und Jugendalters, Klinik für Psychiatrie und Psychotherapie des Kindes- und Jugendalters, Zentralinstitut für Seelische Gesundheit, Medizinische Fakultät Mannheim, Universität Heidelberg, J 5, 68159, Mannheim, Deutschland. ralf.dittmann@zi-mannheim.de.
authors.forename: R W
authors.initials: RW
authors.lastname: Dittmann
mesh_terms: D000296:Adolescent Psychiatry / Q000331:legislation & jurisprudence*; D002665:Child Psychiatry / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000191:economics / Q000331:legislation & jurisprudence; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D005060:Europe; D005858:Germany; D018166:Health Care Reform / Q000191:economics / Q000331:legislation & jurisprudence*; D007880:Legislation, Drug; D008389:Marketing of Health Services / Q000191:economics / Q000331:legislation & jurisprudence*; D017063:Outcome Assessment, Health Care / Q000191:economics / Q000331:legislation & jurisprudence; D011600:Psychopharmacology / Q000331:legislation & jurisprudence*; D011613:Psychotherapy / Q000191:economics / Q000331:legislation & jurisprudence; D011619:Psychotropic Drugs; D011785:Quality Assurance, Health Care / Q000191:economics / Q000331:legislation & jurisprudence
chemical_list: D011619:Psychotropic Drugs
keywords: Assessment of benefit and costs; Child and adolescent psychiatry; Clinical studies; German new drug market law; Psychopharmacology