A comparison of EMA and FDA decisions for new drug marketing applications 2014-2016: concordance, discordance and why.

The Food and Drug Administration (FDA) and European Medicines Agency (EMA) have robust scientific and technical collaborations. As a window to the impact of these activities we compared the agencies' decisions on drug marketing applications. Decisions were compared for 107 new drug applications with a regulatory outcome at both agencies in the period 2014 to 2016. Further analysis addressed individual applications for which the agencies had differing outcomes in terms of marketing approval, type of approval and approved indication, including reasons underlying differences. EMA and FDA had high concordance (91-98%) in decisions on marketing approvals. Divergence in approval decisions, type of approval, and approved indication were primarily due to differences in agencies' conclusions about efficacy based on review of the same data or differing clinical data submitted to support the application. This high rate of concordance suggests that engagement and collaboration on regulatory science has positive impact. This article is protected by copyright. All rights reserved.