title: Priority review drugs approved by the FDA and the EMA: time for international regulatory harmonization of pharmaceuticals?
abstract: BACKGROUND
  The US Food and Drug Administration (FDA) priority review process applies to a drug that is considered a significant improvement over the available alternatives. The European Medicines Agency (EMA) accelerated approval applies to a product that is of major public health interest. This study assessed differences in the characteristics of priority review new molecular entities and new therapeutic biologic products approved by the FDA and the EMA.
  
  
  METHODS
  This study includes regulatory information on drug applications, approvals, indications, and orphan designations of all priority review drugs approved by the FDA and the EMA in the period 1999-2011. Descriptive statistics, t-tests, and chi-squared and Wilcoxon tests were performed.
  
  
  RESULTS
  Overall, 100 FDA priority review new molecular entities and new therapeutic biologics were approved by both agencies; 87.0% of the products were first approved by the FDA. The average FDA review time (9.2 ± 8.4 months) was significantly lower than the EMA average review time (14.6 ± 4.0 months) (p < 0.0001). The FDA and the EMA granted orphan designation to 43.0% and 33.0%, respectively, of the applications. There were differences in the administration route (1.0% of all products), dosage (8.0%), strength (23%), posology (51.0%), indications (30.0%), restrictions of use (52.0%), limitations of use (19.0%), and outcomes limitations (28.0%) approved by both regulatory agencies.
  
  
  CONCLUSIONS
  Significant differences exist in the characteristics of the priority review drugs approved by the FDA and the EMA. Harmonization of the US and European regulatory frameworks may facilitate timely approval of pharmaceutical products.
authors.affiliation: International Center for Pharmaceutical Economics and Policy, Massachusetts College of Pharmacy and Health Sciences (MCPHS University), Boston, MA, USA.
authors.forename: Saad
authors.initials: S
authors.lastname: Alqahtani
authors.affiliation: International Center for Pharmaceutical Economics and Policy, Massachusetts College of Pharmacy and Health Sciences (MCPHS University), Boston, MA, USA.|Division of General Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, USA.
authors.forename: Enrique
authors.initials: E
authors.lastname: Seoane-Vazquez
authors.affiliation: School of Public Health and Health Sciences, University of Massachusetts, Amherst, MA, USA.|The Institute for Global Health, University of Massachusetts, Amherst, MA, USA.
authors.forename: Rosa
authors.initials: R
authors.lastname: Rodriguez-Monguio
authors.affiliation: International Center for Pharmaceutical Economics and Policy, Massachusetts College of Pharmacy and Health Sciences (MCPHS University), Boston, MA, USA.|Division of General Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, USA.|Department of Medicine, McGill University, Montreal, Quebec, Canada.
authors.forename: Tewodros
authors.initials: T
authors.lastname: Eguale
mesh_terms: D017277:Drug Approval / Q000331:legislation & jurisprudence* / Q000458:organization & administration* / Q000706:statistics & numerical data; D005060:Europe; D033161:Government Regulation; D007390:International Agencies; D007391:International Cooperation / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration
keywords: European Medicines Authority (EMA); Food and Drug Administration (FDA); drug indication; drug regulation; marketing approval; pharmacoepidemiology; priority review