• Mwango Kashoki, Zahra Hanaizi, Stella Yordanova, Richard Veselý, Christelle Bouygues, Jordi Llinares, and Sandra L Kweder.
• Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
• Clin. Pharmacol. Ther. 2020 Jan 1; 107 (1): 195-202.

AbstractThe 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.© 2019 European Medicines Agency. Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

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