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Swissmedic has learned from the super-fast procedure with Covid. For many approvals, however, it would be too time-consuming.
Before a drug reaches the patient, it has come a long way: It is first tested on a small number of people, then on larger groups. Only when this hurdle is over does the pharmaceutical company knock on the door of the licensing authority with the whole mountain of data and documents.
With the so-called rolling approval process, the authorities do not wait for the big mountain at the end, but check data continuously. Claus Bolte, Head of Authorizations at Swissmedic, explains: “We are already continuously checking the data parallel to the development and are therefore almost finished with the testing process as soon as the development is completed. That saved a lot of time.”
We continuously check the data parallel to the development and are therefore almost finished with the testing process at the end of the development.
That sounds simple, but overall it is a complex undertaking: According to Bolte, it ranges from the operating license to the inspection of certain facilities for conducting studies to the inspections of the manufacturing processes. In addition, there is the examination of the continuously arriving data: “All of this runs in parallel, which used to be processed strictly one after the other.”
Elaborate “ping-pong game”
As a result, there were no compromises in terms of quality, effectiveness or safety, emphasizes Bolte. On the other hand, the high speed has its price. The procedure is considerably more complex – not only for Swissmedic and other drug authorities, but also for the industry. The constant back and forth, like a game of ping-pong, absorbed more staff than usual. In addition, the great effort is no guarantee for approval.
Expedited procedures only in urgent cases
That is why Swissmedic will only use the higher speed in future if the situation is particularly urgent. For example, with the drugs against Covid. Even before the pandemic, a higher speed was possible in special cases, often with new cancer drugs. In jargon one speaks of accelerated procedures, which can be requested for promising new therapies if there are no alternatives.
There are common elements that we got to know and further developed from the rolling process.
In addition, independent of the pandemic, there are international cooperation projects to speed up the approval process for newer cancer drugs. However, the experiences from the pandemic are now being incorporated into these projects and processes: “There are common elements that we have also learned from the rolling process and further developed. »
SPO supports strategy
The Swiss patient organization SPO trusts the authority: A higher speed is appropriate in exceptional cases. From the point of view of the SPO, there were also improvements in the process during the pandemic: Patients could have reported vaccination side effects directly to the authorities. The SPO is in regular contact with Swissmedic and brings up their concerns.
However, the fact that the vaccines were developed and made available so quickly has not only to do with approval. Because the approval comes at the very end of a long chain of developments that were previously made in research.