Posted by Michael Wonder on 24 Feb 2018
FDA approves drugs before EMA and Swissmedic, comparison finds
23 February 2018 - From 2007 to 2016, the US FDA approved more new drugs and biologics first than its European and Swiss regulatory counterparts, according to a comparison published in the European Journal of Clinical Pharmacology.
“From 2007 to 2016, 134 new drugs were approved by all three regulatory agencies. Overall, 66.4% of the drugs were first approved by the FDA, 30.6% by the EMA, and 3.0% by SMC [Swissmedic]. The difference in approval dates between SMC and the EMA, SMC and the FDA, and the FDA and the EMA were statistically significant,” the comparison found.
The review also offered some perspective on indications approved by FDA, EMA and Swissmedic, as the same drugs were similar in content for almost a quarter of drugs and different in more than three-quarters of the drugs.
