Authorisations of human medicinal products with a new active substance and additional indications 2022

47 human medicinal products with new active substances authorised

Overview of new authorisations 2022

In 2022, Swissmedic, the Swiss Agency for Therapeutic Products, again reviewed and authorised for the Swiss market more medicinal products with new active substances than in previous years.

The increased time needed for the reviews compared to the preceding year is primarily attributable to applications that were submitted and processed during the intensive pandemic years 2020/2021 and completed in 2022. During this time, applications for medicines and vaccines against the coronavirus SARS-CoV-2 were prioritised over other innovative new applications.

The overview shows the indications and the type and duration of the authorisation procedures. Swissmedic is also participating in two benchmarking studies to compare the authorisation times with those of the leading partner authorities. The results of these studies will be published during the course of 2023.

The following overview shows which procedures the applicants used, how long the authorisation processes lasted, and for which indications the medicines were authorised.