Literature DB >> 17267922

Regulatory policies on medicines for psychiatric disorders: is Europe on target?

Corrado Barbui, Silvio Garattini.   

Abstract

The European Medicines Agency (EMEA) is the regulatory body that provides the institutions of the European Community with the best possible scientific advice on the quality, safety and efficacy of medicinal products. Drugs approved by the EMEA are automatically marketable in all the European member states. Since the beginning of the EMEA's activities a number of drugs acting on the central nervous system obtained marketing authorisation. This editorial highlights some aspects of the EMEA rules that may negatively affect the evaluation of medicines for psychiatric disorders.

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Year:  2007        PMID: 17267922     DOI: 10.1192/bjp.bp.106.024794

Source DB:  PubMed          Journal:  Br J Psychiatry        ISSN: 0007-1250            Impact factor:   9.319


  4 in total

Review 1.  Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers.

Authors:  Hans-Georg Eichler; Brigitte Bloechl-Daum; Eric Abadie; David Barnett; Franz König; Steven Pearson
Journal:  Nat Rev Drug Discov       Date:  2010-02-26       Impact factor: 84.694

Review 2.  Bridging the efficacy-effectiveness gap: a regulator's perspective on addressing variability of drug response.

Authors:  Hans-Georg Eichler; Eric Abadie; Alasdair Breckenridge; Bruno Flamion; Lars L Gustafsson; Hubert Leufkens; Malcolm Rowland; Christian K Schneider; Brigitte Bloechl-Daum
Journal:  Nat Rev Drug Discov       Date:  2011-07-01       Impact factor: 84.694

3.  EMA and FDA psychiatric drug trial guidelines: assessment of guideline development and trial design recommendations.

Authors:  Kim Boesen; Peter C Gøtzsche; John P A Ioannidis
Journal:  Epidemiol Psychiatr Sci       Date:  2021-04-30       Impact factor: 6.892

4.  Does the development of new medicinal products in the European Union address global and regional health concerns?

Authors:  Ferrán Catalá-López; Anna García-Altés; Elena Alvarez-Martín; Ricard Gènova-Maleras; Consuelo Morant-Ginestar
Journal:  Popul Health Metr       Date:  2010-12-20
  4 in total

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