Which trials are concerned?
Various types of trials involving human subjects need to be authorised by Swissmedic. An 80% reduction in the flat-rate fees for authorisation procedures is available for certain academic clinical trials; applications for this fee reduction can be submitted with immediate effect.
In order to qualify for a fee reduction, the responsible sponsor must confirm that no commercial third-party funds are being used to carry out all or part of the clinical trial. For other types of funding – e.g. from universities, foundations, the Swiss National Science Foundation or Innosuisse – a fee reduction is possible.
How do I submit an application for fee reduction for a clinical investigation or a performance study?
Submit your application, which consists of the two documents BW610_10_029e_FO_Application_fee_reduction and BW610_10_030e_VL_Application_fee_reduction_selfdeclaration together with your next authorisation application. Place both documents in the ‘00.00_Swissmedic_forms’ folder of your eDok submission. If required, an introduction to eDoks and electronic submissions can be found in Annex A6 of Information Sheet BW600_00_015e_MB or of Information Sheet BW600_00_016e_MB.
Please note: If you receive commercial third-party funding during the course of the trial, you must inform us in the cover letter when you next submit an application.