ArticleDer Nervenarzt2016
[The new German drug market law AMNOG from a child and adolescent psychiatry perspective].
Article in Der Nervenarzt, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundThe 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.
objectivesSummary 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. MATERIAL AND
methodsApplication 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. RESULTS AND
conclusionClearly 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.
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