What is it? Why is it important?

Swissmedic is the Swiss authority regarding the licensing, authorization, and/or monitoring of therapeutic products, including:

  • Human medicine
  • Veterinary medicine
  • Complementary & herbal medicine
  • Medical device

Core competencies include to:

  • Approve studies. In comparison to EC, Swissmedic only approves higher risk studies, such as:
    • Studies with Medicinal Products (MP) that have risk-category B and C (ClinO)
    • Studies with Medical Devices (MD) that have risk category A2 and C (ClinO-MD)
  • Issue licences for the manufacturing of MPs
  • Authorise MPs to be sold on the Swiss market
  • Inspect studies and their compliance with regulatory requirements
  • Monitor the safety and quality of MPs/MDs in studies and on the open market
  • Inspect manufacturing companies to evaluate the quality of MPs/MDs
  • Issue information aimed at healthcare professionals and patients
  • Cooperate with national and international agencies

More

In comparison to MP authorisation requirements, Medical Devices do not undergo official Swissmedic authorisation procedures. For devices, Switzerland has taken over the EU system of compliance and assessment certification (e.g. based on bilateral agreements). The visible result of a compliance assessment is the so-called CE label, which permits medical devices to be placed / sold on the market, both within the EU and Switzerland.

Swissmedic is attached to the Federal Department of Home Affairs.

What do I need to do?

As a SP-INV and based on the risk-category of your study, submit your study to Swissmedic for approval.

Submission can be done concurrently with the EC submission. EC submission is required for all studies irrespective of the risk-category of the study.

As a SP-INV or Site-INV, ensure that the protection of study participants always takes priority over any scientific or financial interest.

Where can I get help?

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

External Links

Swissmedic – see in particular

  • Human medicines / Clinical trials
  • Medical devices / Clinical trials

References

ICH GCP E6(R2) – see in particular article

  • Art. 1.49 Definition regulatory authorities

KOFAM: Coordination portal for human research – see in particular

  • Online wizard for risk categorisation
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CE – Conformité Européenne
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • EU – European Union
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • KOFAM – Coordination Office for Human Research
  • MD – Medicinal Device
  • MP – Medicinal Product
Basic ↦ Ethics and Laws ↦ Authorities ↦ Swissmedic
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Basic ↦ Ethics and Laws ↦ Authorities ↦ Swissmedic

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