What is it? Why is it important?

The Swissmedic portal allows access to the various Swissmedic eGov services. It offers a secure electronic communication platform between study investigators and Swissmedic.

In Switzerland, the eSubmissions portal is the electronic tool for the submission of clinical studies with MDs and standardized transplants

What do I need to do?

To use the portal, you must sign a user agreement with Swissmedic.

When planning MD or transplant studies, ask a user administrator or an account administrator at your institution to help you with the creation of a user account.

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

External Links

Swissmedic – see in particular

  • BW101_10_004e_AA Guideline Clinical Trial Application Dossier (Selection: Clinical Trial Application – document)
  • Selection: medical devices / clinical trials / clinical investigations / how to submit?
  • eGov Service eSubmission (Selection: Services & list / Swissmedic Portal)
  • CTU – Clinical Trials Unit
  • MD – Medical Device
Basic ↦ Ethics and Laws ↦ Submission Portal ↦ Swissmedic Portal

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Basic ↦ Ethics and Laws ↦ Submission Portal ↦ Swissmedic Portal

Please note: the Easy-GCS tool is currently under construction.