FDA Drug Approval Process Comparatively Speedy

JUNE 14, 2012

The FDA is frequently criticized for its lengthy drug review process, but a data analysis published in the May 16, 2012, issue of the New England Journal of Medicine shows that the regulatory agency approves drugs significantly more quickly and earlier than its counterparts in Europe and Canada. The analysis, carried out by researchers at the Yale School of Medicine, looked at 510 applications for novel therapeutic agents approved by the FDA, the European Medicines Agency (EMA), or Health Canada between 2001 and 2010.

Among these applications, 225 were approved by the FDA, 186 by the EMA, and 99 by Health Canada. They included 289 unique agents, 72 of which were approved by all 3 agencies. The median total length of review for these 72 agents was 268 days at the FDA, 356 days at the EMA, and 366 days at Health Canada. For all applications within the decade covered by the study, the median total length of review was 322 days at the FDA, 366 days at the EMA, and 393 days at Health Canada. In addition, of the 190 agents approved in both the United States and Europe, 121 (63.7%) were approved first in the United States. Likewise, of the 154 agents approved in both the United States and Canada, 132 (85.7%) were approved first in the United States.


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