What is it? Why is it important?
The HRA ordinances regulate which studies require, in addition to EC, an approval from Swissmedic. Main criteria for a Swissmedic approval are study type and risk-category.
Except for risk-category A studies, the following studies require a Swissmedic approval.
ClinO studies with:
- Investigational Medicinal Product (IMP) & risk-categories B or C
- Standardized transplants & risk-category C
- Gene therapy, GMO, pathogenic organisms, studies involving ionising radiation & risk-categories B or C
ClinO-MD studies with:
- Investigational Medical Device (IMD) & risk-category C
Apart from EC and Swissmedic approval, additional approval or consulting requirements exist:
- ClinO category C studies involving ionising radiation, transplantation of human organs, tissues and cells, require an approval from the FOPH
- Before issuing an approval order, Swissmedic seeks the opinions from other legal institutions (e.g. SECB, FOEN)
What do I need to do?
As a SP-INV, access Swissmedic homepage where the application process is explained, including:
- Ways to compile a Clinical Trial Application (CTA) dossier
- Separate and specific step-by-step guidance for dossier application for IMP and IMD
- For ClinO-MD studies, a step by step guidance on how to submit the application dossier via the electronic portal system (service eGov “eMessage”)
- Guidance on how to submit ClinO studies (without in vitro diagnostics MD combinations) (eDoc structure) by postal mail, either with a full paper dossier or with a paperless dossier
Ensure the application dossier is complete, as it will otherwise be rejected by Swissmedic.
You can submit in parallel to Swissmedic, EC, and if applicable FOPH. Approvals must be received before starting the study.
ClinO studies (without MDs) are submitted by post in both paper and electronic formats:Option: full paper submission:
- Prepare a binder and include a copy of each document. File with number index
- Comprise the registers based on “Instructions for filling the eDoc folder structure”
- Burn a CD. Use the same structure
- Submit binders and CD by postOption: paperless submission:
- Print and sign the paper form “Confirmation electronic submission”
- Burn a CD with documents organized based on “Instructions for filling the eDoc folder structure”
- Submit the form and CD by post
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
Swissmedic – see in particular
- Human medicine / Clinical trials / Clinical trials on medicinal products
- Medical devices / Clinical trials / Authorisation procedure
- Services & Lists / eGOV services
- Services & Lists / submissions
FEDLEX – laws are available online under numbers
- 810.305 ClinO
- 810.306 ClinO-MD
ClinO – see in particular articles
- Art. 30 Exemption from mandatory authorisation
- Art. 31 Application
ClinO-MD – see in particular articles
- Art. 7 Exemption from mandatory authorisation
- Art. 16 Application