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 EC and Swissmedic requirements
- Swissmedic obtains:
- No objections from the 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/MD or combination studies (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 FOPH.
What do I need to do?
As a SP-INV, ensure that after approval:
- As applicable, the Swissmedic and EC reference numbers are included in all future correspondence
- A robust document tracking system is in place (e.g. ensures that only Swissmedic and EC approved documents are used in the study)
- Modifications to approved documents are re-submitted to Swissmedic and EC for approval (e.g. and only implemented after approval)
File all Swissmedic and EC correspondence including the official Swissmedic and EC approvals in the TMF, and if applicable in the ISF of participating study sites.
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
FEDLEX – law is available online under number
- 810.305 ClinO
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