Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

New drug approval success rate in Europe in 2009

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

Subjects

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(EMA) to be fully transparent about the outcomes of all marketing authorization applications (MAAs), including those withdrawn by the applicant prior to receiving a regulatory opinion.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).

This is a preview of subscription content, access via your institution

Relevant articles

Open Access articles citing this article.

Access options

Rent or buy this article

Get just this article for as long as you need it

$39.95

Learn more

Prices may be subject to local taxes which are calculated during checkout

References

  1. Czerepak, E. A. & Ryser, S. Drug approvals and failures: implications for alliances. Nature Rev. Drug Discov. 7, 197–198 (2008).

    Article  CAS  Google Scholar 

  2. European Commission. Notice to Applicants. Volume 2A: procedures for marketing authorisation. Chapter 1: marketing authorisation. November 2005. EC website [online], (2005).

  3. European Medicines Agency. Human medicines. EMA website [online], (2010).

  4. Pignatti, F. et al. The review of drug applications submitted to the European Medicines Evaluation Agency: frequently raised objections, and outcome. Eur. J. Clin. Pharmacol. 58, 573–580 (2002).

    Article  PubMed  Google Scholar 

  5. European Medicines Agency. Withdrawal assessment report for vorinostat MSD 100 mg hard capsules. EMA website [online], (2008).

  6. Regnstrom, J. et al. Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency. Eur. J. Clin. Pharmacol. 66, 39–48 (2010).

    Article  PubMed  Google Scholar 

  7. Hughes, B. 2009 FDA drug approvals. Nature Rev. Drug Discov. 9, 89–92 (2010).

    Article  CAS  Google Scholar 

  8. Eichler, H.-G. et al. Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma. Nature Rev. Drug Discov. 7, 818–826 (2008).

    Article  CAS  Google Scholar 

  9. European Medicines Agency. Reflection paper on benefit–risk assessment methods in the context of the evaluation of marketing authorisation applications of medicinal products for human use. EMA website [online], (2008).

Download references

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
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Bo Aronsson
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Eric Abadie
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Tomas Salmonson
    View author publications

    You can also search for this author in PubMed Google Scholar

Ethics declarations

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)

Rights and permissions

Reprints and Permissions

About this article

Cite this article

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

Download citation

  • Issue Date:

  • DOI: https://doi.org/10.1038/nrd3169

This article is cited by

Search

Advanced search

Quick links

Nature Briefing: Translational Research

Sign up for the Nature Briefing: Translational Research newsletter — top stories in biotechnology, drug discovery and pharma.

Get what matters in translational research, free to your inbox weekly. Sign up for Nature Briefing: Translational Research