The New England Journal of Medicine compared review times for new therapeutic agents that were approved by the The Food and Drug Administration (FDA) or The European Medicines Agency (EMA) between 2011 and 2015.
The FDA approved 170 new therapeutic agents between 2011 and 2015, and the EMA approved 144. The therapeutic areas of the approvals were similar in the two agencies, although more therapeutic agents that were designated as orphan drugs were approved by the FDA than by the EMA (43.5% vs. 25.0% of the approved agents). The median total review time was 306 days at the FDA, as compared with 383 days at the EMA. The total review times were shorter at the FDA than at the EMA for therapeutic agents that are used for the treatment of cancer and hematologic disease, but not for other therapeutic areas, and for therapeutic agents that were designated as orphan drugs. Among the 142 therapeutic agents that were approved by both the FDA and the EMA (with approval by at least one regulator occurring during the sample period), the median total review time was 303 days at the FDA, as compared with 369 days at the EMA.
For new therapeutic agents that were approved between 2011 and 2015, the regulatory reviews by the FDA were, on average, 60 days shorter than those by the EMA.