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Pharmaceuticals / Submissions and Approvals

FDA Approved More Drugs First Than European Regulators

Feb. 28, 2018

The FDA outpaced the European Medicines Agency in first approvals of new biologics over the past decade, according to research published in the European Journal of Clinical Pharmacology.

The researchers looked at three regulatory authorities FDA, EMA and Swissmedic. The three authorities approved 134 new drugs between 2007 and 2016, with two-thirds first approved by the FDA, compared to 30.6 percent by the EMA and 3 percent by Swissmedic.

The researchers found significant differences in indications approved by the FDA and the other two regulators. They also found significant differences in the characteristics of new drugs approved by the agencies despite increased efforts toward regulatory harmonization.

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