What is it? Why is it important?
Beyond regulatory requirements for IMPs, IMDs including their combinations, the Human Research Act (HRA) regulates, through its ordinance (ClinO), additional requirements for investigations using radiation sources.
Requirements apply to investigations as well as (diagnostic) examination (e.g. CT scan, X-rays, etc.) using an effective person dose exceeding 5 mSv per year. In addition the radiopharmaceutical product under investigation:
- Is not authorised in Switzerland
- Is authorised in Switzerland, but where the investigation is not a routine nuclear medical examination, or
- Another radioactive source is used altogether
The regulatory requirements and approvals for studies with radiation sources, are beyond existing regulatory requirements for studies with IMP, IMP/IMD combinations.
What do I need to do?
For studies investigating products capable of emitting ionising radiation, you are required to know and comply with requirements defined in the ClinO ordinance.
Aspects to consider:
- The authorization status of the radiopharmaceutical under investigation (e.g. approval status in Switzerland)
- Planned radiation dose and participant exposure
- Required licence for administering radioactive substances to humans
- Completion of the required research application form for FOPH submission
Submit an application to:
- The FOPH, if the effective dose per person > 5 mSv per year
- EC who grants authorisation of category A, B, and C studies and provides its first reply within:
- 45 days, if the FOPH raises no objection to the study
- Swissmedic who grants authorisation of category B and C studies and grants its first reply within:
- 60 days, if the FOPH raises no objection to the study
The FOPH delivers its opinion to EC with respect to:
- The compliance with radiological protection legislation and on the dose estimation
EC, FOPH, and Swissmedic submission can be done in parallel as they coordinate their assessments.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, 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.ctc.usz.ch
KOFAM: Coordination portal for human research – see in particular
- Online wizard for risk categorisation
FEDLEX – laws are available online under numbers
- 810.305 ClinO
- 810.306 ClinO-MD
- 814.50 RPA
ClinO – see in particular articles
- Art. 28 Procedures and deadlines EC
- Art. 36 Special provisions
RPA – see in particular article
- Art. 28 Mandatory licencing