What is it? Why is it important?
The approval of studies on gene therapy and genetically modified pathogenic organisms (e.g. risk-categories B and C) is obtained if:
- The study fulfils Ethics Committee (EC) and Swissmedic requirements
- Swissmedic obtains:
- No objections from the Federal Office of Public Health (FOPH)
- Confirmation by the SECB regarding product quality and biological safety
- No objection from the FOEN regarding environmental concerns
Approval of category C studies with products capable of emitting ionising radiation, including IMP, IMD or a (I)MP & (I)MD combination study (in vitro) is obtained if:
- Studies fulfil EC and Swissmedic requirements
- The FOPH raises no objections to EC or Swissmedic, regarding compliance with radiation protection legislation and dose estimation
Swissmedic reaches a decision within 60 days and informs FOPH, SECB, and FOEN, as applicable.
EC reaches a decision within 45 days and informs the FOPH.
What do I need to do?
As a SP-INV, ensure that after approval:
- The Swissmedic and EC reference numbers are included in all future correspondence
- A robust document tracking system is in place (e.g. document identification)
- Modifications to approved documents are re-submitted to Swissmedic and EC for approval (e.g. and only implemented after approval)
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
ClinO – see in particular articles
- Art. 52. Exemption from mandatory authorisation
- Art. 53 Reviews area
- Art. 54 Authorisation procedure
- Art. 56 Special provisions for transplantation of embryonic or foetal tissues and cells
ClinO-MD – see in particular articles
- Art. 3 Applicable provisions
- Art. 14 Procedure for investigation with radiation sources
HRO – see in particular article
- Art. 19 Procedure for trials involving radiation sources