The speed and care with which an authority carries out an authorization procedure is crucial for the industry and patients alike. In this respect, Swissmedic is measured above all against the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).
In an international comparison of the processing time for scientific assessments, Swissmedic is on a par with the fastest authorities
In the latest published R&D Briefing 77, the Centre for Innovation in Regulatory Science (CIRS) compares key approval data for the six major authorities EMA, FDA, PMDA, Health Canada, TGA and Swissmedic. On the one hand, the report compares the number and duration of approvals in various drug categories and, on the other, examines the special regulatory features of the various jurisdictions, particularly as regards simplified authorisation procedures ("Facilitated Regulatory Pathways").
The processing time in Switzerland for applications for new active substances (NAS) was 520 calendar days in 2019, i.e. 277 days more than for the FDA, the world's fastest authority. However, for the first time the latest R&D Briefing also shows the time taken for the scientific assessment alone. At Swissmedic this phase lasts just 312 days, an impressive performance by the Swiss authority in an international comparison. Nevertheless, Swissmedic continues to make every effort to reduce the overall approval time.
Calculation of the approval time
The latest R&D Briefing considers an aspect of the overall time to market authorisation (approval time) of medicines that had not previously been addressed: for the first time, not only the approval time, but also the processing time for the scientific assessment is shown separately. These key tasks between the milestones of "Doc. OK" and "Preliminary decision of approval", which also includes replying to the List of Questions by the applicant, take 312 days on average in Switzerland. This means that Swissmedic is the third fastest authority after the FDA and EMA.
Nevertheless, the approval time of 520 days is still too long. The labelling process after completion of the scientific assessment is still too time-consuming and the subject of further optimisation measures.
Facilitated Regulatory Pathways
In 2019, the overall approval time for applications in the Swissmedic fast-track authorisation procedure (FTP) averaged 300 days. The period for the approval of innovative medicines with high therapeutic benefit is therefore comparable with that of the EMA (270 days) and the FDA (238 days). The time for the scientific assessment in the Swissmedic FTP was just 187 days – a figure that could not be beaten by any other agency.
The proportion of applications in the fast-track procedure for new active substances has tended to decline over recent years, both at Swissmedic and the EMA. Both authorities employ comparable eligibility criteria for the fast-track procedure although, on the whole, Swissmedic tends to use the FTP slightly more frequently than the EMA uses the equivalent "Accelerated Assessment".
As a special feature, Swissmedic also offers the option to expedite the process by Prior Notification. No scientific qualifying criteria exist for the Procedure with Prior Notification (PPN), and the Swissmedic processing time is shortened by 20% thanks to the improved fixed planning. In 2019, the PPN employed for four applications resulted in a fast average approval time of just 430 days.
The average submission gap at Swissmedic for NASs approved by all six authorities, was 110 days in the period 2015-2019. This period for Swissmedic is comparable with that in Australia and Canada. There are numerous reasons for large submission gaps. These include market forces, which are almost impossible to influence. However, Swissmedic will continue its efforts at various levels to establish itself in the long term as a competent and independent first-wave agency on the international market.