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 the Ethics Committee (EC) Swissmedic only approves higher risk studies (e.g. risk categories B and C), such as:
    • Studies with Medicinal Products (MP) that have risk-category B and C (ClinO)
    • Studies with Medical Devices (MD) that have risk category 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 and guidelines (e.g. Swiss Law, ICH GCP, ISO 14155)
  • 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


In comparison to MPs authorisation requirements, MDs do not undergo official Swissmedic authorisation procedures. For devices, Switzerland has taken over the EU system of compliance and assessment certification. The visible result of a compliance assessment is the so-called CE label, which permits medical devices to be placed / sold on the market.

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,  keep in mind to notify to Swissmedic any:


ensure that the protection and safety (e.g. risk-benefit) of study participants always takes priority over any scientific or financial interest (e.g. conflict of 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


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

Swiss Law

ClinO – see in particular articles and annex

  • Art. 23 Coordination and information in authorisation procedures
  • Art. 30-34 Swissmedic Submission, Timelines and Approval Process including Studies with Radiation Source
  • Annex 4 Application
  • 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
  • SP-INV – Sponsor Investigator
Basic ↦ Ethics and Laws ↦ Authorities ↦ Swissmedic

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 ↦ Authorities ↦ Swissmedic

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