FDA moves faster than EMA: study

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A Yale assistant professor and a medical student have provided evidence that FDA's review process is faster than those in other countries. In May, their study in the New England Journal of Medicine examined the time it took FDA, EMA, and Health Canada to complete a new drug's initial review. FDA clocked in at 303 days compared with 366 days at Europe's EMA and 352 at Health Canada.

Following up in the June issue of Forbes, they re-crunched the numbers to consider total time to approval. “The median time to approval,” they wrote, “was 322 days at the FDA, compared to 366 days at the EMA and 409 days at Health Canada.”

The researchers' comparison is complicated by the fact that the three regulators do not review the same way. “Among these applications that were eventually approved,” they said, “the EMA approved almost every one in a single review cycle, 96%. In contrast, 62% and 69% of applications were approved by the FDA and Health Canada in a single review cycle, respectively. For the FDA, 36% required two cycles and 1% required three cycles. You might think that extra requests for statistical analysis, data collection, or even new clinical trials would make the FDA process more time-consuming than that in other countries, but it doesn't.”
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