What is it? Why is it important?

Based on ClinO, duties and responsibilities of the Federal Office of Public health (FOPH) include the authorisation of clinical studies.

Swissmedic seeks the opinion of the FOPH in the following studies:

  • Gene therapy and genetically modified pathogenic organisms (risk-categories B and C)
  • IMP/MD combinations (in vitro) capable of emitting ionising radiation (risk-category C)
  • Use of a radiation source exceeding 5mSv per year for participants (risk-category C)

The EC seeks the opinion of the FOPH for the following studies:

  • Transplantation of human organs, tissues and cells (risk-category C)
  • Use of a radiation source exceeding 5mSv per year for participants (risk-category C)

Regarding studies of gene therapy and genetically modified / pathogenic organisms, Swissmedic together with the FOPH and the FOEN jointly issue guidelines on risks to human health and the environment.

What do I need to do?

As a SP-INV, submit the following studies for approval to the FOPH:

  • Transplantation of human organs, tissues and cells (risk-category C)
  • Studies with radiation sources that exceed 5 mSv per year for participants (risk-category C)

As these studies are also submitted to EC and Swissmedic, they can be submitted in parallel.

Refer to the ClinO and its annexes regarding submission requirements to the FOPH.

Where can I get help?

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

References

FOPH – see in particular tabs

  • Medicine & research / Research involving humans
  • Medicine & research / Research involving human embryonic stem cells
  • Laws & Licenses / Applications & Approvals / Biosafety: notifications & authorisations
  • Laws & Licenses / Applications & Approvals / Exemption authorisations and authorisations banned narcotics

Swiss Law

FEDLEX – laws are available online under numbers

  • 810.301 HRO
  • 810.305 ClinO
  • 810.306 ClinO-MD

ClinO – see in particular articles and annexes

  • Art. 28 Procedure for investigation with radiation sources
  • Art. 35 Procedure for gene therapy and genetically modified pathogenic organism
  • Art. 36 Procedure for IMP and in vitro diagnostic MDs or combination capable of emitting ionising radiation
  • Art. 50 Coordination in authorisation procedures for organ, tissue or cells transplantation
  • Art. 52 Exemption from mandatory authorisation for organ, tissue or cells transplantation
  • Annex 3 Submission requirements for investigation with radiation sources
  • Annex. 4 Submission requirements for transplantation, gene therapy, genetically modified/pathogenic organism

ClinO-MD – see in particular articles and annex

  • Art. 14 Procedure for investigation with radiation sources
  • Art. 18 Trials with MD capable of emitting ionising radiation
  • Annex 1 Submission document list

HRO – see in particular article and annex

  • Art.19 Procedure for trials involving radiation sources
  • Annex 2 Submission document list
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FEDLEX – Publication Platform for Federal Laws
  • FOEN – Federal Office for the Environment
  • FOPH – Federal Office of Public Health
  • HRO – Human Research Ordinance
  • IMD – Investigational Medical Device
  • IMP – Investigational Medicinal Product
  • MD – Medical Device
  • mSv – Millisievert
  • SP-INV – Sponsor Investigator
Development ↦ Ethics and Laws ↦ Federal Office of Public Health ↦ Submission
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 ↦ Ethics and Laws ↦ Federal Office of Public Health ↦ Submission

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