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

Swiss Law

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
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • 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
  • IMD – Investigational Medical Device
  • IMP – Investigational Medicinal Product
  • ISF – Investigator Site File
  • SECB – Swiss Committee for Biosafety
  • SP-INV – Sponsor Investigator
  • TMF – Trial Master File
Development ↦ Ethics and Laws ↦ Federal Office of Public Health ↦ Approval
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 ↦ Federal Office of Public Health ↦ Approval

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