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Fostering dialogue with national authorities

The SCTO advocates for a more favourable regulatory environment for clinical research in Switzerland and leads the activities of the Coordination Platform for Clinical Research on this topic. At our annual roundtable, we opened a dialogue with Swissmedic and swissethics about GCP inspections.

Highlights 2022

  • The seventh annual roundtable took place on the topic of GCP inspections.
  • SCTO is represented in the Roundtable on Medical Technology hosted by Swissmedic.

Seventh roundtable was focused on GCP inspections

For academic clinical trials, inspection fees are a major burden on their budgets. Our seventh roundtable fostered mutual understanding between all parties and provided an opportunity to exchange novel approaches and ideas.

Our take-home messages from the discussion

  • Swissmedic plans to increase the number of inspections so that 10% of all ongoing clinical trials in Switzerland will be inspected. With about 400 ongoing category B and C clinical trials, the number of inspections will increase to 40 in 2023.
  • For the submission of clinical investigations and in vitro diagnostic medical devices (IVD) performance studies, Swissmedic, swissethics, and the Federal Office of Public Health (FOPH) have developed an information sheet with a useful decision tree for authorisation applications.
  • swissethics has observed many missing numbers in their primary registries; therefore, they appealed to the group to increase the awareness of this important requirement.

SCTO is now represented in the Roundtable on Medical Technology

The enactment of the EU’s new Medical Device Regulation in 2019 entailed many changes and challenges for everyone involved with medical devices in Switzerland. In 2022, Swissmedic announced a reorientation in the composition of the Roundtable on Medical Technology (RTMT) members; they explicitly want to involve other stakeholder groups along with industry partners. The SCTO applied for membership in the RTMT and became a representative in May 2022.