title: Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study.
abstract: OBJECTIVE
  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).
  
  
  METHODS
  We performed a cross-sectional analysis of all novel medicines approved by the EMA through the centralized authorization procedure between 2001 and 2010. PMSEs were defined as withdrawals and communications identified through Dear Healthcare Professional Communications (DHPCs). Regulatory review time was defined as the time that elapsed between the start of the assessment procedure and approval. Near regulatory deadline approval was defined as approval within the 30 days before the EMA's 210 day regulatory deadline.
  
  
  RESULTS
  Among 161 eligible medicines, PMSEs were identified for 49 (30.4%), 44 of which were DHPCs, five of which were withdrawals. Median regulatory review time was 337 days (IQR 276-406) and was not associated with PMSEs (P = 0.57). However, when categorized by regulatory review speed tertile, there were differences in risk of PMSEs, with higher rates among medicines in the middle tertile (25 of 55, 45.4%; P = 0.01). Finally, 26 medicines were approved near the 210 day regulatory deadline, but were not more likely to have PMSEs (38.5% vs. 28.7%; P = 0.32).
  
  
  CONCLUSIONS
  Neither faster EMA regulatory review speed nor approval near regulatory deadlines was associated with greater likelihood of PMSEs among recently approved novel medicines.
authors: Sciences Po, Paris, France.|Department of Gastroenterology and Nutrition, Saint-Antoine Hospital, APHP, Paris.|Department of Proctology, Croix Saint-Simon Hospital, Paris, France.
authors: Jean-David
authors: JD
authors: Zeitoun
authors: Department of General and Digestive Surgery, Saint-Antoine Hospital, APHP, Paris, France.|University Paris VI, Paris, France.
authors: Jérémie H
authors: JH
authors: Lefèvre
authors: Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut, USA.
authors: Nicholas S
authors: NS
authors: Downing
authors: Sciences Po, Paris, France.|Senior Research Fellow at the National Centre for Scientific Research (CNRS), France.
authors: Henri
authors: H
authors: Bergeron
authors: Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut, USA.|Section of General Internal Medicine and the Robert Wood Johnson Clinical Scholars Program, Department of Internal Medicine, Yale University School of Medicine.|Department of Health Policy and Management, Yale University School of Public Health, New Haven, Connecticut, USA.
authors: Joseph S
authors: JS
authors: Ross
mesh_terms: D003430:Cross-Sectional Studies; D017277:Drug Approval; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005060:Europe / Q000453:epidemiology; D033161:Government Regulation; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data*; D013997:Time Factors
keywords: European Medicines Agency; drug approval; government regulation; prescription drugs; regulatory review time; safety