High degree of alignment in drug approvals between EU and US


  • Dawn O'Shea
  • Univadis Medical News
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A new analysis has shown a high degree of alignment in drug approvals between the European Union (EU) and the United States (US). The analysis, carried out jointly by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), showed the agencies were aligned in more than 90 per cent of marketing authorisation decisions for 107 new medicine applications between 2014 and 2016.

The most common reason for diverging decisions at the two agencies were differences in conclusions about efficacy. The second most common reason was differences in clinical data submitted, in some cases due to the difference in the timing of submissions. More applications were submitted to the FDA before they were submitted to EMA.

Compared to the FDA, the EMA often reviewed applications including additional clinical trials or, particularly for oncology medicines, more mature data from the same clinical trial. In those instances, the EMA was more likely than the FDA to grant standard approval, a broader indication or use of a medicine as first-line therapy.

Most of the information used for the study was sourced from the EMA’s European Public Assessment Reports (EPARs) and FDA reviews, which contain the agencies’ rationale for their decisions on applications.