Swiss drug review times trail FDA and EMA, increased due to COVID
While lagging other regulators in bringing new drugs to market, Swiss regulators say their review times are comparable to the European Medicines Agency (EMA) and attributed recent delays in approvals to the COVID-19 pandemic.The Swiss Agency for Therapeutic Products (Swissmedic) published a report on 17 August comparing its drug approval times to those of the EMA and US Food and Drug Administration (FDA). The agency noted that while it lagged significantly behind US regulators, its review times match with those of EMA.
“Although analysis of throughput times for new applications for new active substances (NA NAS) across all procedures reveals a slightly longer lead time, Swissmedic's median figures are on a par with the EMA’s,” said Swissmedic. “The delays are attributable to the increased strain on resources during the COVID pandemic in 2020/21, when applications for medicinal products to combat or prevent the disease were given priority over other innovative new applications.”
In 2021, the average throughput time for new drug applications submitted to Swissmedic was 391 calendar days, which increased to 413 days in 2022. Those numbers are very similar to the EMA's, which rose from 401 in 2021 to 411 calendar days in 2022. FDA had much faster times, with 223 average calendar days in 2021 and 273 days in 2022.
Overall, Swissmedic says it has narrowed its submission and approval gaps compared with EMA and FDA. The agency noted that its submission gap with EMA has narrowed by 30%, and that the gap with FDA has narrowed even more, closing by 45%. It attributes closing the gap primarily due to its participation in the Access Consortium and Project Orbis.
The Access Consortium is a partnership between Australia, Canada, Singapore, the United Kingdom and Switzerland that harmonizes regulatory requirements across the participating regulatory regimes. Similarly, FDA's Project Orbis lets sponsors submit cancer drug applications in multiple regulatory regimes that allow the same drug to be reviewed across national borders simultaneously.
While the percentage of Orbis and Access approvals stayed the same, Swissmedic noted that fast-track authorization procedures and temporary authorizations went up 16% from 10% and 38% from 23% in 2022 compared to 2021, respectively.
“Despite the progress achieved on the submission and approval gaps, both increased compared with the FDA for NA NAS in the standard procedure sub-group (524 CD, +18% for submission gap; 895 CD, +43% for approval gap),” Swissmedic added. “The benchmarking study only started recording the submission and approval gaps in 2021, but will continue to monitor it and track the trend over the next few years.”
While Swissmedic has made substantial progress, a Center for Innovation in Regulatory Science (CIRS) report from earlier this summer puts Swissmedic and EMA far behind other international regulators, including authorities in Canada, Australia and Japan, in terms of median approval times for new drugs.
Swiss medic report
CIRS report
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