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Clin Pharmacol Ther. 2019 Jul 15. doi: 10.1002/cpt.1565. [Epub ahead of print]

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

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Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
PAREXEL Consulting, PAREXEL International, Billerica, Massachusetts, USA.
Scientific and Regulatory Management Department, Human Medicines Evaluation Division, European Medicines Agency, Amsterdam, The Netherlands.
Europe Office, Office of Global Policy and Strategy, US Food and Drug Administration, Silver Spring, Maryland, USA.


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.


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