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]

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

Domains: Humanities and Social Sciences; Sociology

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. ⟨10.1111/bcp.12643⟩. ⟨hal-01521129⟩