EMA And FDA Claim 'High Concordance' In Approval Decisions

Divergences between the EU and US agencies in marketing application approval decisions in 2014-2016 were primarily due to differences in the regulators’ conclusions about efficacy based on review of the same data or to differing clinical data submitted to support the application, a study has revealed.

US-EU-flags — The EMA and FDA say concordance in their approval decisions is high • Source: Shutterstock

The European Medicines Agency and the US Food and Drug Administration came to the same decision for over 90% of 107 marketing authorization applications between 2014 and 2016, a first-of-a-kind study conducted by both regulators has shown.

Concordance between the EMA and the FDA was high at 91% for initial decisions on marketing approvals, and even higher...