Alessandro Zappalorto /
19 August 2019AmericasSarah Morgan

EMA and FDA aligned on marketing authorisations: report

The US and Europe have reached the same conclusion in more than 90% of marketing authorisation decisions for new medicines, according to a report from the European Medicines Agency (EMA).

The report, a joint effort between the EMA and the Food and Drug Administration (FDA), compared 107 new medicine applications at the two agencies between 2014 and 2016.

This high rate of convergence is the result of expanded investment in dialogue and cooperation since 2003, according to a press release from the EMA.

Differences in conclusions about efficacy were the most common reason for diverging decisions at the two agencies, with differences in clinical data submitted in support of an application was the second most common root of divergent decisions.

Zaide Frias, head of the EMA’s human medicines evaluation division, said: ”Our cooperation clearly supports both agencies in achieving a common goal of maximising patient access to safe, effective and high quality medicines in both regions.”

Overall, 84% of the applications in the cohort studied were approved on their first submission by both the EMA and the FDA, with the EMA having a higher rate of “first review cycle” approval (92%) compared with the FDA (85%).

This is the first analysis by EMA and the FDA that compares the agencies’ decisions related to marketing authorisations.

Compared with the US agency, the EMA often reviewed applications including additional clinical trials or, particularly for oncology medicines, more mature data from the same clinical trial.

In these cases, the European agency was more likely than the FDA to grant standard approval, a broader indication, or use of a medicine as first-line therapy, according to the study.

Over the past decade, the agencies have established joint working groups and forums for information sharing and collaboration.

The collaboration includes ‘ clusters’ on special topics and therapeutic areas, in addition to parallel scientific advice and protocol assistance.

Did you enjoy reading this story?  Sign up to our free newsletters and get stories like this sent straight to your inbox.

Already registered?

Login to your account

To request a FREE 2-week trial subscription, please signup.
NOTE - this can take up to 48hrs to be approved.

Two Weeks Free Trial

For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at