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

FOPH - see in particular topics

  • Medicine & Research / Research involving humans
  • Medicine & Research / Research involving human embryonic stem cells
  • Laws & Licences / Notifications and authorisations in the field of biosafety
  • Laws & Licences / Exceptional licences and licences for banned narcotics

Swiss Law

OrgO-HRA see in particular chapter

  • Chapter 2 Coordination Office

ClinO – see in particular article and annexes

  • Art. 36 Assessment, notification and reporting on the use of radiation sources
  • Annex 4 Application documents to FOPH

HRO – see in particular article and annex

  • Art. 23 Assessment, notification and reporting on the use of radiation sources
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical CTU – Clinical Trials Unit
  • FOPH – Federal Office of Public Health
  • HIV – Human Immunodeficiency Virus
  • HCV – Hepatitis-C-Virus
  • HRO – Human Research Ordinance
  • mSv – Millisievert
  • OrgO-HRA – Ordinance on Organisational Aspects of the Human Research Act
Basic ↦ Ethics and Laws ↦ Authorities ↦ Federal Office of Public Health

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 ↦ Federal Office of Public Health

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