Swissmedic survey finds drug approval timelines slower than EMA, FDA
A new study by Swissmedic shows that it takes significantly more time to authorize new drugs in Switzerland than in the EU or US, and the gap is growing compared to the agency’s previous report.Swissmedic recently conducted its 11th benchmarking study on review times for applications for new applications for new active substances (NA NAS), additional indications (AIs), new applications for known active substances with or without innovation (NA KAS with/without innovation), new applications for biosimilars and new applications for herbal medicinal products under the simplified procedure (NA herbal medicinal products). The study results were published on 24 July and showed a widening gap between the three regulatory bodies.
Swiss regulators found that, on average, their NA NAS standard procedure throughput times took 15% longer in 2023 compared to 2022. This trend was more pronounced for orphan drugs, which took 72% longer to review.
“Swissmedic was 11% slower than the EMA on NA NAS (all procedures) and 19% slower on AI applications (all procedures),” said Swissmedic. “The FDA remained substantially faster than Swissmedic, with throughput times that were 31% shorter for NA NAS (all procedures) and 48% shorter for AIs (all procedures).”
“Overall, both the submission gap and the approval gap widened year-on-year against the reference authorities EMA and FDA,” it added. “The exceptions to this were NA NAS under the standard procedure, where the submission and approval gaps were shorter than the previous year compared with both the EMA and FDA.”
The survey also found that generic drugs (KAS without innovation) took slightly longer to review than in the EU, and the text reviews during the labeling phase also took significantly longer, especially in KAS drugs.
NA NAS drug application throughput times between Swissmedic and EMA did narrow in 2022, with the average time in Switzerland reaching 413 days and the average time in Europe reaching 411 days. Since then, average throughput times in the EU have dropped significantly to 399 days in 2023, while in Switzerland, they have gone up to 442 days. FDA was markedly faster at reviewing applications, with the average review time in the US being 305 days in 2023.
The survey found that Swissmedic's and EMA's submission and approval times in calendar days (CD) have also grown substantially year over year.
"The submission gap was 244 CDs, 105% higher than in 2022," said Swissmedic. "At 249 CDs, the approval gap was also higher (+48%).”
"Compared with the FDA, the submission gap for NA NAS across all procedures rose 53% compared with the previous year from 177 to 270 CDs," it added. "The approval gap also increased 46% from 252 to 369 CDs."
Benchmarking study
×
Welcome to the new RAPS Digital Experience
We have completed our migration to a new platform and are pleased to introduce the updated site.
What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.
We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.
We welcome your feedback. Please let us know how we can continue to improve your experience.