For the eleventh time in succession, Swissmedic, the Swiss authority for the authorisation and monitoring of therapeutic products, and the Swiss pharmaceutical industry associations (ASSGP, Intergenerika, Interpharma, scienceindustries and vips) have conducted a benchmarking study analysing the times required to authorise human medicinal products in Switzerland and comparing them with the equivalent times for the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). The results provide a factual basis for the ongoing dialogue between Swissmedic and the pharmaceutical industry. They help identify and implement improvements in the authorisation processes for human medicinal products.
The analysis is based on new applications for new active substances (NA NAS), additional indications (AI) and procedures for known active substances (KAS). The applications submitted for the study by participating authorisation holders account for 78.9% of the total Swiss market and 83.9% of the market for prescription-only medicinal products.
Compared with the previous year, throughput times for Swissmedic authorisation procedures followed divergent trends.
The study identified rising throughput times (+15%) for NA NAS in the standard procedure, the effect being particularly pronounced (+72%) in the orphan drugs subgroup owing to a high level of text review rounds. There were no material changes observed in AI applications.
Throughput times for NA NAS under the Type A Orbis procedure and under Art. 13 TPA were substantially (28% and 24% respectively) shorter than in the previous year.
Swissmedic was 11% slower than the EMA on NA NAS (all procedures) and 19% slower on AI applications (all procedures). The FDA was again significantly faster than Swissmedic: throughput times were 31% shorter for NA NAS (all procedures) and 48% shorter for AI (all procedures).
Overall, both the submission gap and the approval gap widened year-on-year against the reference authorities EMA and FDA. 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.
In the case of known active substances, the throughput times for KAS without innovation (generics) in the standard procedure were slightly longer than in the EU. Throughput times for cases where the procedure under Art. 13 TPA was applied were shortened compared with the standard procedure.
In the labelling phase, the percentage of applications with text review rounds increased overall from 20% to 28%. The increase was most pronounced among KAS (from 14% to 25%).
Other trends and findings from the study can be found in the Executive Summary.