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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

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 (Sciences Po, CNRS)
6 YSM - Yale School of Medicine [New Haven, Connecticut]
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
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Journal articles
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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, August 5, 2022 - 3:42:06 AM

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UNIV-PARIS7 | SCIENCESPO | CNRS | CSO | SORBONNE-UNIVERSITE | SU-MEDECINE | UNIV-PARIS

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Jean-David Zeitoun, Jérémie H. Lefevre, Nicholas Downing, Henri Bergeron, Joseph S. Ross. Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study. British Journal of Clinical Pharmacology, 2015, 80 (4), pp.716 - 725. ⟨hal-01521129⟩

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