Publication of the 'Swiss specific addendum' for clinical trials according to ClinO

Swissmedic and swissethics have communicated that applications under the ClinO that are submitted before November 1, 2024, under the old law can only be approved under the new law after November 1, 2024. Therefore, the condition that the requirements under the new law must be met before the first person is enrolled in a trial in Switzerland, will be stated in the decision letter. These requirements are now included in the “Swiss specific addendum” published today (link). Sponsors have the option of submitting the new requirements by submitting this addendum in addition to the already submitted study protocol for final approval by the ethics committee and Swissmedic. Only after these requirements have been met and final approval under the new law has been granted can the first person be enrolled in the clinical trial.