title: A new approach to psychiatric drug approval in Europe.
abstract: Corrado Barbui and Irene Bighelli question the current rules governing registration of new medicines in Europe, using the example of psychiatric drugs, and argue that the concept of absolute efficacy should be replaced by the concept of added value whereby evidence from studies comparing a new product with an active comparator should guide the drug approval process. Please see later in the article for the Editors' Summary.
authors.affiliation: WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, Department of Public Health and Community Medicine, Section of Psychiatry, University of Verona, Verona, Italy.
authors.forename: Corrado
authors.initials: C
authors.lastname: Barbui
authors.forename: Irene
authors.initials: I
authors.lastname: Bighelli
mesh_terms: D017277:Drug Approval / Q000331:legislation & jurisprudence*; D005060:Europe; D006801:Humans