What is it? Why is it important?

Swissmedic is a federal institution acting as a surveillance authority for medicines and medical devices. Swissmedic is thus the regulatory authority of Switzerland.

Any medical product aimed for humans or animals use, needs approval from Swissmedic prior to being distributed on the Swiss market.

Based on ClinO, the following studies must obtain approval by Swissmedic prior to implementation:

  • Medical Device category C studies
  • Investigational Medicinal- and transplant products with a category B or C study
  • Gene therapy, genetically modified pathogenic organism, and ionising radiation with a category B of C study

More

Swissmedic:

  • Authorizes market access to new therapeutic products based on internationally acknowledged criteria, guaranteeing quality, safety and efficacy
  • Specifies conditions of sale (e.g. on prescription only; packaging, labelling, record keeping)
  • Approves information for healthcare professionals and patients.

As an inspection authority, Swissmedic focuses on:

  • Quality and Safety of IMP/MD
  • GCP and GVP
  • Risk Management
  • Quality of study site(s)
  • GMP

What do I need to do?

In the event your study must be submitted to Swissmedic, visit the Swissmedic website for guidance.

  • Useful information guides you through the Clinical Trial Application (CTA) process
  • Requirements needed to compile a complete CTA dossier are listed
  • As a SP-INV you can simultaneously submit an application to Swissmedic and the EC

The EC and Swissmedic do coordinate their assessments regarding incoming study applications.

For more information refer to Ethics and Laws in this Study Guide.

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

External Links

www.swissmedic.ch

References

ClinO – see in particular article and annex

  • Art. 23 Coordination and information in authorisation procedures
  • Art. 30-34 Swissmedic Submission, Timelines and Approval Process including Studies with Radiation Source
  • Annex 4 Application documents to swissmedic
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • CTA – Clinical Trial Application
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • GMP – Good Manufacturing Practice
  • GVP – Good Pharmacovigilance Practice
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • IMP/MD - Investigational Medicinal Product / Medical Device
  • SP-INV – Sponsor-Investigator
Development ↦ Management ↦ Study Approval ↦ Swissmedic
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 ↦ Management ↦ Study Approval ↦ Swissmedic

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