Study Compares Regulatory Review at FDA with EMA

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A new study in NEJM compares the regulatory review processes of FDA and EMA.

A new study in the New England Journal of Medicine (NEJM) published on April 6, 2017 compares the regulatory review process at FDA with the European Medicines Agency (EMA). The study, which focuses on new therapeutic agents, shows that FDA approved 170 new therapeutic agents between 2011 and 2015, while EMA approved 144.

The median total review time for therapeutic agents during this period, according to the researchers, was 306 days at FDA and 383 days at EMA. On average, reviews at FDA were 60 days shorter than reviews at EMA for therapeutics approved between 2011 and 2015.

However, the authors also noted that while review times were shorter at FDA for therapeutics intended to treat cancer and hematologic diseases, this was not the case for other therapeutic areas. They also found the review time was longer at FDA compared with EMA for orphan drugs.

The NEJM study authors said the statistics are comparable to, and greater than, a previous analysis of review times of therapeutics approved between 2001 and 2010. “Our analysis provides reassurance that FDA continues to complete regulatory reviews more quickly than the EMA and has the potential to inform discussions regarding the reauthorization of the PDUFA [The Prescription Drug User Fee Act],” they conclude.


The new presidential administration has become increasingly critical of FDA’s approval process. President Trump has referred to the process as “slow and burdensome” and the administration is putting increased pressure on FDA to accelerate review of drugs. Although it is still unclear if the administration will recommend any changes to the process, the NEJM study demonstrates that compared to its counterpart, FDA has been able to review new medicines efficiently.

Source: NEJM