Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study

Jean-David Zeitoun; Jérémie H. Lefevre; Nicholas Downing; Henri Bergeron; Joseph S. Ross

Journal articles

Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study

Jean-David Zeitoun ^{1, 2} Jérémie H. Lefevre ³ Nicholas Downing ⁴ Henri Bergeron ⁵ Joseph S. Ross ⁶

1 Service de Gastroentérologie et nutrition [CHU Saint-Antoine]

2 Dpt proctologie [CHU Croix St Simon]

3 Hôpital Beaujon

4 Brigham and Women's Hospital [Boston]

5 CSO - Centre de sociologie des organisations

6 Yale University School of Medicine

Abstract : Regulatory review time has been associated with post-market medication safety issues in the United States. Our objective was to evaluate whether regulatory review time and near deadline approval are associated with post-market safety events (PMSEs) for novel medicines approved by the European Medicines Agency (EMA).

Keywords : European Medicines Agency drug approval government regulation

Document type :

Journal articles

Domain :

Humanities and Social Sciences / Sociology

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https://hal-sciencespo.archives-ouvertes.fr/hal-01521129
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Submitted on : Thursday, May 11, 2017 - 2:45:27 PM
Last modification on : Friday, October 15, 2021 - 5:20:02 PM

Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study

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Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study

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