In Swissmedic's information materials, combined studies are understood to refer to the following:
- A study in which both a clinical trial with a medicinal product or an advanced therapy medicinal product (ATMP) and an interventional performance study with in vitro diagnostics are carried out in parallel.
- A study in which both a clinical trial with a medicinal product or advanced therapy medicinal product (ATMP) and a clinical investigation with medical devices are carried out in parallel.
Both the requirements for trials with medicinal products and ATMPs and those for trials with medical devices apply.
When do I need approval from Swissmedic for combined studies?
a) Clarify if the clinical trial of medicinal products or ATMPs is in category B or C and therefore requires approval from Swissmedic. You can find the criteria in Art. 19 ClinO.
b) Clarify
- whether the interventional performance study of in vitro diagnostics requires approval from Swissmedic. A decision-making tool is available here: Decision tree for performance studies
- or whether the clinical investigation of medical devices requires approval from Swissmedic. A decision-making tool is available here: Decision tree for clinical investigations
If an approval from Swissmedic is required for both a) and b), you must submit a single application that includes all information for both aspects.
If you have any questions, please contact the responsible ethics committee. In Switzerland, ethics committees are responsible for the differentiation and categorisation of research projects.
How do I submit applications for approval and notifications to Swissmedic?
You can find instructions in the information sheet BW600_00_017e_MB.
Please always ensure that you refer to the latest version of the information sheet. The procedures may change in the future.