Study shows FDA faster at reviews than EMA, Health Canada

FDA reviewed novel therapeutics significantly faster than EMA and Health Canada during 2001-10, and the majority of those products were first approved in the U.S., according to a study by Yale University researchers. The median length of time to complete the first review was 303 days for applications approved by FDA, compared with 366 days for EMA and 352 days for Health Canada (p<0.0001). The median total review time, which includes multiple review cycles, was also significantly shorter at FDA compared with both EMA and Health Canada (322 days vs. 366 and 393; p=0.002).

For products approved in the U.S. and Europe, 64% were first approved in the U.S. For products approved in the U.S. and Canada, 86% were first approved in the U.S. EMA did approve 96% of products after just one review cycle, compared to 62% of products approved by FDA and 69% of products approved by Health Canada. Data were published in the New England Journal of Medicine. ...