FDA Approves Drugs Before EMA and Swissmedic, Comparison Finds

Posted 23 February 2018 | By Zachary Brennan 

FDA Approves Drugs Before EMA and Swissmedic, Comparison Finds

From 2007 to 2016, the US Food and Drug Administration (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.

“Significant differences in indications existed between the FDA and SMC and the FDA and the EMA, but not between the EMA and SMC,” said the review, written by researchers from the School of Pharmaceutical Sciences at the University of Geneva, Geneva University hospitals and Oregon-based Chapman University.

And though cross-border regulatory harmonization has been a goal, the review notes in its conclusion that “significant differences in the characteristics of new drugs approved by different agencies persist.”

A comparison of new drugs approved by the FDA, the EMA, and Swissmedic: an assessment of the international harmonization of drugs

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