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Factors influencing non-approval of new drugs in Europe

Nature Reviews Drug Discovery volume 11, pages 903–904 (2012)Cite this article

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Analysis

Of all 68 applications evaluated by the EMA Committee for Medicinal Products for Human use (CHMP), 45 (66%) were approved, whereas 23 (34%) were not; 6 received a negative opinion and 17 were voluntarily withdrawn by the applicant before a final opinion was made by the CHMP. The summary scores in the three categories — development plan, clinical outcome and clinical relevance — are shown in Table 1, stratified for approved and non-approved applications. All eight drugs with a positive rating for the development plan, a positive clinical outcome and convincing clinical relevance were approved, whereas 12 out of 14 applications for which all three scores were negative were not approved.

Table 1 Summary scorecard of EMA assessment of 68 MAAs*
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References

  1. Eichler, H. G. et al. New drug approval success rate in Europe in 2009. Nature Rev. Drug Discov. 9, 355–356 (2010).

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Author information

Authors and Affiliations

  1. Division of Pharmacoepidemiology and Clinical Pharmacology, Michelle Putzeist, Aukje K. Mantel-Teeuwisse and Hubert G. M. Leufkens are at the Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Universiteitsweg 99, 3584 CG Utrecht, The Netherlands.,

    Michelle Putzeist, Aukje K. Mantel-Teeuwisse & Hubert G. M. Leufkens

  2. Michelle Putzeist, Christine C. Gispen de Wied and Hubert G. M. Leufkens are at the Medicines Evaluation Board, Graadt van Roggenweg 500, 3531 AH Utrecht, The Netherlands.,

    Michelle Putzeist, Christine C. Gispen-de Wied & Hubert G. M. Leufkens

  3. Bo Aronsson, Spiros Vamvakas and Hans-Georg Eichler are at the European Medicines Agency, 7 Westferry Circus, London E14 4HB, UK.,

    Bo Aronsson, Spiros Vamvakas & Hans-Georg Eichler

  4. Malcolm Rowland is at the School of Pharmacy and Pharmaceutical Sciences, University of Manchester, Oxford Road, Manchester M13 9PT, UK.,

    Malcolm Rowland

  5. Arno W. Hoes is at the Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Universiteitsweg 100, 3584 CG Utrecht, The Netherlands.,

    Arno W. Hoes

Authors
  1. Michelle Putzeist
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  2. Aukje K. Mantel-Teeuwisse
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  3. Bo Aronsson
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  4. Malcolm Rowland
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  5. Christine C. Gispen-de Wied
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  6. Spiros Vamvakas
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  7. Arno W. Hoes
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  8. Hubert G. M. Leufkens
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  9. Hans-Georg Eichler
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Competing interests

All authors declare no conflict of interest relevant to the subject matter or materials discussed in the manuscript. This study was funded by the Dutch Top Institute Pharma Escher project (T6-202).The department of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, has received unrestricted research funding from the Netherlands Organisation for Health Research and Development (ZonMW), the Dutch Health Care Insurance Board (CVZ), the Royal Dutch Pharmacists Association (KNMP), the private–public-funded Top Institute Pharma, including co-funding from universities, government, and industry, the EU Innovative Medicines Initiative (IMI), the EU seventh Framework Program (FP7), the Dutch Medicines Evaluation Board, the Dutch Ministry of Health and industry (including GlaxoSmithKline, Pfizer and others).

Supplementary information

Supplementary information S1

Key variables and scores for development plan, clinical outcome and clinical relevance (PDF 160 kb)

Supplementary information S2

Methodology (PDF 136 kb)

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Putzeist, M., Mantel-Teeuwisse, A., Aronsson, B. et al. Factors influencing non-approval of new drugs in Europe. Nat Rev Drug Discov 11, 903–904 (2012). https://doi.org/10.1038/nrd3894

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