What is it? Why is it important?

The Swiss Federal Office of Public Health (FOPH) is responsible for public health in Switzerland.

Responsibilities include to:

  • Develop Swiss health care policies
  • Protect the country’s public health (e.g. promote healthy lifestyles, ensure high quality health care)
  • Ensure that the country has an efficient and affordable healthcare system affordable and accessible to all
  • Authorize studies on the transplantation of human organs, tissues, and cells
  • Assess participant radiation exposure in studies with ionising radiation

What do I need to do?

Notification / authorisation / opinion by the FOPH is required in studies with:

  • Biosafety measures (e.g. genetically modified, pathogenic or alien organisms)
  • Infectious diseases (e.g. HIV, HCV)
  • Banned narcotics
  • Stem cells research
  • Transplants of human organs, tissue and cells
  • Ionizing radiation with an effective dose > 5 mSv per year and
  • Radiopharmaceutical that has:
    • No authorization in Switzerland
    • An authorization in Switzerland but will be applied for a non-authorized indication
  • Using of another radioactive source

Where can I get help?

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

Federal Office of Public Health – see in particular

  • The FOPH / Tasks & Goals
  • Medicine & Research
Abbreviations
  • CTU – Clinical Trials Unit
  • FOPH – Federal Office of Public Health
  • HIV – Human Immunodeficiency Virus
  • HCV – Hepatitis-C-Virus
  • mSv – Millisievert
Basic ↦ Ethics and Laws ↦ Authorities ↦ Federal Office of Public Health
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 ↦ Federal Office of Public Health

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