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EMA and FDA comparison shows faster, and higher, approval rates in the US

According to a report in the New England Journal of Medicine, which compared drug approval times in the US and Europe from 2011 to 2015, the US Food and Drug Administration (FDA) approves drugs 25% more quickly on average than the European Medicines Agency (EMA), with their median days to approval at 306 days and 383 days respectively.

When comparing like for like, medicines that were approved by both authorities showed the same pattern, with the average time to approval through the EMA at 369 days vs 303 days for the FDA. For new therapeutic agents coming to the market, again review times were 60 days shorter through the FDA. When all of the data is taken together, the extent of the difference in total review times between the two agencies has remained similar to the previous study that compared drugs approved between 2001 – 2010, although in certain areas the discrepancy is greater in favour of the FDA.

During the study period, the therapeutic areas of approval were similar, but the FDA approved 170 drugs, of which 43% were orphan drugs, compared to a total of 144 through the EMA, of which just 25% were orphan drugs. All of this points to the efficacy of the Prescription Drug User Fee Act (PDUFA) which was passed in 1992, allowing the FDA to collect fees from drug manufacturers to fund new drug approvals, and which is up for reauthorisation later this year.

The EMA is set for major change with the move from its UK headquarters in the near future following the Brexit vote, with the final destination still undecided, although many cities are still vying for consideration, including Ireland, Croatia, Malta, Spain, Portugal, Italy, France, Denmark, Sweden, Finland, Hungary, Bulgaria and the Netherlands.