US vs. Europe: New research paper compares drug review times across borders
The US boasted faster review times for drug applications over the past decade compared to those in the EU and Switzerland, according to a new paper published Monday in the Annals of Internal Medicine.
The researchers assessed the length of regulatory review times for both primary and supplemental indications in the US and Europe between 2011 and 2020 as well as differences in submission times during that period. The researchers found that overall, the median review time, from submission to approval, was 39 weeks (about nine months) in the US compared with 44 weeks (about 10 months) in the EU and Switzerland.
The FDA’s PDUFA VII deal established that FDA must review and and act on 90% of standard applications within 10 months of the 60-day filing date, whereas for expedited submissions, FDA is tasked with completing 90% within six months. The EMA says its reviews typically take about one year, with the review clock stopped at various points in the process.
The Annals researchers accounted for “clock stop” periods in application reviews, during which the respective agency is not actively reviewing the application while it awaits responses to questions from the applicant. Overall, the EMA was 29% slower, and Swissmedic was 39% slower than the FDA, but excluding the clock stop period, the agencies were 6% slower and 7% slower than the FDA, respectively.
The paper underscores that minimizing the differences in review times between the US and Europe will help increase patient access to needed drugs.
Kerstin Vokinger, a professor of law and medicine at the University of Zurich and the lead author of the paper, told Endpoints News that manufacturers should try and submit their applications to different agencies at the same time or as close as possible to each other. She said this will help patients receive equal and quick access to new drugs.
Regulators have also begun further collaborations to review cancer drug applications in parallel, including via FDA’s Project Orbis, with Swissmedic, Health Canada, Australia’s TGA and others.
Kerstin VokingerVokinger said these agencies should work more on parallel review of drug applications.
The paper emphasizes that in the 1980s, the US focused on speeding up review times in response to concerns that it was lagging behind the EU. Since then, the FDA made strides in establishing expedited review programs, like the accelerated approval pathway and priority review, to speed up review times.
“Faster is not always better — drugs with high therapeutic value should be prioritized in the review process,” she said. “But accelerated approval should be applied cautiously.”
For review times within each drug, the EMA took a median of 3.9 weeks longer to review applications than the FDA, while Swissmedic took a median of 0.3 weeks longer.
Review times for secondary indications were faster across the board, but the US was still faster than the EU in that area.
Further, the paper reveals that applications in the EU were submitted about 1.3 weeks later than than they were in the US, and in Switzerland, they were submitted about 17.9 weeks later than in the US.
