What is it? Why is it important?

The Federal Office of Public Health (FOPH):

 

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

  • 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 risk-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?

As a SP-INV, clarify whether you need FOPH submission for your study.

 

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 products that have:
    • No authorization in Switzerland
    • An authorization in Switzerland but will be used for a non-authorized indication
  • Radioactive sources

 

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

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

 

In addition to EC, submit to the FOPH HRO research projects with radiation sources exceeding 5mSv/year per participant.

 

Where can I get help?

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

External Links

Federal Office of Public Health (FOPH) – see in particular

  • The FOPH / Tasks & Goals
  • Medicine & Research

FOPH - see in particular

  • 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 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
  • ClinO – Clinical Trials Ordinance
  • 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
  • SP-INV – Sponsor Investigator
Development ↦ Management ↦ Study Approval ↦ Fed. Off. Public Health
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Statistic Methodology
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Statistic Methodology
Set-Up Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Statistic Methodology
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistic Methodology
Completion Drug or Device
Current Path (click to copy): Development ↦ Management ↦ Study Approval ↦ Fed. Off. Public Health

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