Study: FDA Approves Drugs Faster than Europe, Canada

May 17, 2012

Drugs are approved faster in the US than in Europe and Canada, new research from Yale University School of Medicine shows. Authors of the study, published in The New England Journal of Medicine, reviewed decisions from 2001 to 2010 by the FDA and regulators in Canada and Europe, Health Canada and the European Medicines Agency (EMA), respectively. For drugs approved by all three agencies, the FDA was more than three months faster than Canada or Europe. The study found 64 percent of medicines approved in the US and Europe were approved by the FDA first, and 86 percent of medicines approved in both the US and Canada were also approved first in the US. Total review time at the FDA was faster than the EMA, despite the FDA's higher proportion of applications requiring multiple regulatory reviews, according to the study.

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