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European regulatory experience with drugs for central nervous system disorders

Nature Reviews Drug Discovery volume 14, pages 89–90 (2015)Cite this article

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Analysis

The data set included all of the MAAs in psychiatry and neurology (as defined in the International Classification of Disease (ICD)-10) that had been submitted to the EMA since its establishment in January 1995 and that had reached an outcome by the analysis cut-off date in December 2013. We focused on initial MAAs and excluded so-called 'multiple applications', generic applications and post-authorization procedures (including indication extensions); for details of the data and analysis methods, see Supplementary information S1 (box).

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Figure 1
Figure 2: Number of approved marketing authorization applications by therapeutic indication from 1995 to 2013.

References

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Acknowledgements

We are most grateful to N. Zafiropoulos for his assistance with the EMA database, and to M. Posch, A. Elsäßer and L. Guizzaro for their advice on the statistical analysis.

Author information

Authors and Affiliations

  1. European Medicines Agency, 30 Churchill Place, Canary Wharf, London, E14 5EU, United Kingdom

    Florence Butlen-Ducuing, Malgorzata Zienowicz, Frank Pétavy, Manuel Haas, Hans-Georg Eichler & Guido Rasi

  2. Medical Products Agency, SE-751 03 Uppsala, Sweden, and is Chair of the CHMP.,

    Tomas Salmonson

Authors
  1. Florence Butlen-Ducuing
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  2. Malgorzata Zienowicz
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  3. Frank Pétavy
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  4. Manuel Haas
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  5. Tomas Salmonson
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  6. Hans-Georg Eichler
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  7. Guido Rasi
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Corresponding author

Correspondence to Florence Butlen-Ducuing.

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Competing interests

The authors declare no competing financial interests.

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Supplementary information

Supplementary information S1 (box)

Terminology and analysis methods (PDF 88 kb)

Supplementary information S2 (Table)

Approved marketing authorization applications for drugs in psychiatry and neurology from 1995 to 2013 (PDF 89 kb)

Supplementary information S3 (box)

Additional information and analyses (PDF 227 kb)

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Butlen-Ducuing, F., Zienowicz, M., Pétavy, F. et al. European regulatory experience with drugs for central nervous system disorders. Nat Rev Drug Discov 14, 89–90 (2015). https://doi.org/10.1038/nrd4511

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