A Comparison of EMA and FDA Decisions for New Drug Marketing Applications 2014-2016: Concordance, Discordance, and Why

Abstract

The Food and Drug Administration (FDA) and the 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 2014-2016. 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. The EMA and the 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 a positive impact.

Figure 1

Reasons for initial discordant outcomes, for differences in type of marketing approval and for notable differences in approved indications. Note: Some applications had more than one reason for the difference in outcome; therefore the number of differences is superior to the number of applications in the respective categories.