EMA, FDA Analysis Shows High Degree of Alignment in Drug Approvals

By Emily Forster -

August 29, 2019

The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have published a joint analysis that shows the two are aligned in more than 90% of marketing authorization decisions for new medicines. This is one of the findings of the joint analysis comparing the agencies’ decisions on 107 new medicine applications between 2014 and 2016.

The EMA says this is the first analysis by the two agencies that compares their decisions related to marketing authorizations. Some differences were observed in the clinical data due to the difference in timing of submissions, where more applications were submitted to the FDA before they were submitted to the EMA.

The study also looked at applications for which the agencies had differing outcomes in terms of types of approval and indication. The most common reason for diverging decisions at the two agencies were differences in conclusions about efficacy. Differences in clinical data submitted in support of an application were the second-most common root of divergent FDA and EMA decisions.

Compared to the FDA, the EMA noted it 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 a first-line therapy.

Over the past decade, the EMA and the FDA have established joint working groups and several forums for information-sharing and collaboration around many aspects of medicine development and regulation, including areas of cooperation focusing on special topics and therapeutic areas, as well as parallel scientific advice and protocol assistance. The EMA says while these groups are not forums for shared decision-making, the strong alignment in decisions on marketing authorizations suggests that they may be contributing to alignment on regulatory science.

Source: European Medicines Agency