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New drug approval success rate in Europe in 2009

Nature Reviews Drug Discovery volume 9, pages 355–356 (2010)Cite this article

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Recent European Union (EU) legislation obliges the European Medicines Agency (EMA) to be fully transparent about the outcomes of all marketing authorization applications (MAAs), including those withdrawn by the applicant prior to receiving a regulatory opinion. This provides the possibility of analysing the current success rate of MAAs for new active substances (NASs) submitted through the EU's centralized procedure. An NAS is broadly defined as a chemical, biological or radiopharmaceutical substance not previously authorized as a medicinal product in the EU2 (for full definition, see Supplementary information S1 (box)). Under the definition, biosimilar products may also be considered as NASs. However, for the analysis presented here, we modified this definition to exclude biosimilar applications, as these were deemed not to be truly new developments. In addition, when multiple applications were filed for the same NAS, only one was counted. Our definition of an NAS is similar but not identical to the FDA's definitions of new molecular entities (NMEs) and biologic licence applications (BLAs).

Regulatory outcomes in 2009

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Author information

Author notes

  1. to H.-G. E. Hans-Georg.Eichler@ema.europa.eu Disclaimer: The views expressed in this article are the personal views of the author(s) and may not be understood or quoted as being made on behalf of or reflecting the position of the EMA or any other regulatory agency or its committees or working parties.

Authors and Affiliations

  1. Hans-Georg Eichler, Senior Medical Officer, and Bo Aronsson are at the EMA, 7 Westferry Circus, London E14 4HB, UK.,

    Hans-Georg Eichler & Bo Aronsson

  2. Eric Abadie, Chair of the EMA's CHMP, is at the General Directorate, Agence française de sécurité sanitaire des produits de santé (Afssaps), 43/147, bd Anatole France 93285, Saint-Denis Cedex, France.,

    Eric Abadie

  3. Tomas Salmonson, Sweden; Vice-Chair of EMA's CHMP, is at Läkemedelsverket Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, Sweden.,

    Tomas Salmonson

  4. Vice-Chair of EMA's CHMP, is at Läkemedelsverket Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, Sweden.,

    Tomas Salmonson

Authors
  1. Hans-Georg Eichler
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  2. Bo Aronsson
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  3. Eric Abadie
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  4. Tomas Salmonson
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Competing interests

The authors declare no competing financial interests.

Supplementary information

Supplementary information S1 (table)

MAAs for new active substances in the EU with a negative outcome in 2009 (PDF 144 kb)

Supplementary information S2 (box)

Definition of a new active substance in the European Union (PDF 139 kb)

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Eichler, HG., Aronsson, B., Abadie, E. et al. New drug approval success rate in Europe in 2009. Nat Rev Drug Discov 9, 355–356 (2010). https://doi.org/10.1038/nrd3169

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