1 September 2025 – Swissmedic, together with swissethics, has published a position paper on clinical trials with medicinal products examined for the first time in humans (early phase I studies). Special aspects must be considered in planning and conducting such trials in order to ensure participant’s safety.

Sponsor requirements include identifying and mitigating the risks of the clinical trial. For example, the risk assessment should include the safety profile of the investigational medicinal product, the set-up of the trial and the population studied. Requirements related to the investigator site personnel and facilities include training and experience, supervision and resources, facilities and equipment as well as emergency.

For more information, see here.