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.

More

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

External Links

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

Swiss Law

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
Abbreviations
  • BASEC – Business Administration System for Ethics Committees
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CTA – Clinical Trial Application
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FEDLEX – Publication Platform for Federal Laws
  • FOEN – Federal Office for the Environment
  • FOPH – Federal Office of Public Health
  • GMO – Genetically Modified Organisms
  • IMD – Investigational Medicinal Device
  • IMP – Investigational Medicinal Product
  • MD – Medical Device
  • SECB – Swiss Expert Committee for Biosafety
  • SP-INV – Sponsor Investigator
Development ↦ Ethics and Laws ↦ Ethics Application ↦ Submission
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Development ↦ Ethics and Laws ↦ Ethics Application ↦ Submission

Please note: the Easy-GCS tool is currently under construction.