Development↦Management↦Study Approval↦Fed. Off. Public Health
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
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
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
FOPH - see in particular
- Medicine & Research
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