Despite the seemingly slow pace of the US Food and Drug Administration (FDA) drug approval process, the agency actually approves drugs faster and earlier than regulators in Canada and Europe, according to a review of a decade of drug approvals published online May 16 in the New England Journal of Medicine.
Researchers at Yale University School of Medicine found that for drugs approved between 2001 and 2010, the median total time of FDA review was 322 days, compared to 366 days at the European Medicines Agency (EMA) and 393 days at Health Canada. “The total review time at the FDA was faster than EMA, despite the FDA’s far higher proportion of applications requiring multiple regulatory reviews,” study author Nicholas Downing said in a press release.
In total, 510 drug applications were approved by the 3 agencies in those 10 years: 225 by the FDA, 186 by the EMA, and 99 by Health Canada. And many therapies were first approved for use in the U.S., the authors found: about 64 percent of therapies approved in both the U.S. and in Europe, and 86 percent of those approved in both the U.S. and Canada, received their US approval first.