What is it? Why is it important?

The Federal Office of Public Health (FOPH):

  • Is responsible for the health of the population, including an efficient and affordable health care system.
  • Provides an evaluation to Swissmedic and EC regarding studies of/with:
    • Gene therapy, genetically modified pathogenic organisms
    • Transplantation of human organs, tissues and cells.
    • Radiation sources with more than 5mSv/year for participants.

More

For category B and C studies on gene therapy, genetically modified pathogenic organism, Swissmedic will grant authorisation if:

  • FOPH raises no objections
  • Swiss Expert Committee for Biosafety (SECB) has confirmed the quality and biological safety of the product
  • Federal Office for the Environment (FOEN) has no objections based an environmental assessments

For category C studies on therapeutic products capable of emitting ionising radiation, Swissmedic will grant authorisation if the FOPH raises no objections.

What do I need to do?

Clarify whether your study needs FOPH submission.

In addition to Swissmedic and EC, following ClinO studies submit to FOPH:

  • Category B and C studies with transplantation of human organs, tissues and cells
  • Category C studies with radiation sources exceeding 5mSv/year for participants

In addition to EC, submit HRO studies with radiation sources exceeding 5mSv/year for participants to FOPH.

For more information refer to Ethics and Laws in this Study Guide.

Where can I get help?

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

External Links

BAG/OFSP/UFSP/FOPH seen in particular - www.bag.admin.ch

  • Transplantationsgesetz, SR 810.21
  • Transplantationsverordnung, SR 810.211
  • Xenotransplantationsverordnung, SR 810.213
  • Strahlenschutzgesetz
  • Strahlenschutzverordnung

www.kofam.ch

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 3 Application documents to EC
  • 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
  • Annex 2 Application documents to EC
Abbreviations
  • BAG - Bundesamt für Gesundheit
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FOEN – Federal Office for the Environment
  • FOPH - Federal Office of Public Health
  • OFSP – Office Fédéral de la Santé Publique
  • HRO – Human Research Ordinance
  • KOFAM – Koordinationsstelle Forschung am Menschen
  • SECB - Swiss Expert Committee for Biosafety
  • UFSP – Ufficio federale della sanità pubblica
Development ↦ Management ↦ Study Approval ↦ FOPH
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): Development ↦ Management ↦ Study Approval ↦ FOPH

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