While many critics have called for streamlining the Food and Drug Administration's approval process, a new analysis published in the New England Journal of Medicine shows the agency approved a higher amount of drugs at a quicker rate than its European counterpart, the European Medicines Agency.
For the analysis, researchers identified every therapeutic agent approved by the FDA or EMA between 2011 and 2015. They also looked at regulatory timelines to compare median total review times between the two agencies.
Here are four findings.
1. The FDA approved 170 new drugs from 2011 to 2015, while the EMA approved 144 in the same time period.
2. The FDA approved more orphan drugs — 43.5 percent of all approved drugs — compared to the EMA, where 25 percent of approved drugs had an orphan drug designation.
3. The median total review time at the FDA was 306 days, compared to 383 days at the EMA.
4. The regulatory review length for new drugs approved at the FDA was 60 days shorter than the EMA's regulatory timeline, on average.
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