11 May 2026

Swissmedic has clarified the requirements for clinical trials of medicinal products and ATMPs conducted with multiple sponsors in Switzerland. Where several sponsors are involved, all sponsor obligations under the Clinical Trials Ordinance and GCP rules must be fully met, with roles and responsibilities clearly documented and contractually defined. The multi-sponsor arrangement must be transparently disclosed to both Swissmedic and the competent ethics committees, and all sponsor names must appear explicitly in the informed consent documentation. On liability, sponsors are jointly and severally liable, requiring either a shared insurance policy covering all sponsors or individual proof of insurance paired with an explicit acknowledgment of joint and several liability. These requirements apply analogously to clinical investigations with medical devices and performance studies with in vitro diagnostics, where responsibilities must equally be regulated contractually and within each sponsor's quality management system.

For more information, see here.