What is it? Why is it important?

Swissmedic is the Swiss authority responsible for licensing, authorization, and/or monitoring of therapeutic products, including:

  • Human medicine
  • Veterinary medicine
  • Complementary & herbal medicine
  • Medical devices

 

Core competencies include to:

  • Approve clinical studies. In comparison to the Ethics Committee (EC) who approves studies of all risk-categories (i.e. A, B, and C), Swissmedic only approves studies with risk-categories B and C, such as:
  • Issue licences for the manufacturing of MPs
  • Authorise MPs to be sold on the Swiss market
  • Inspect studies to assess compliance with regulatory requirements and guidelines (e.g. Swiss Law, ICH GCP, ISO 14155)
  • Monitor the safety and quality of MPs/MDs in studies and on the open market
  • Inspect manufacturing companies to evaluate the quality of MPs/MDs
  • Issue information aimed at healthcare professionals and patients
  • Cooperate with national and international agencies

More

In comparison to MP authorisation requirements, MDs do not undergo official Swissmedic authorisation procedures. For MDs, Switzerland has adopted the EU system of compliance and assessment certification. Following the compliance assessmen, MDs are granted an CE label, which permits MDs to be placed / sold on the Swiss market.

 

Swissmedic is attached to the Federal Department of Home Affairs.

What do I need to do?

As a SP-INV with a risk-category B or C study, submit an application dossier for approval to Swissmedic over the Swissmedic application portal.

 

Submission can be done concurrently with the EC submission. EC submission is required for all studies irrespective of the risk-category of the study.

 

As a SP-INV keep in mind to notify to Swissmedic any:

Where can I get help?

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

External Links

Swissmedic - see in particular

  • Human medicines / Clinical trials
  • Medical devices / Clinical trials

References

ICH GCP E6(R2) see in particular article

  • Art. 1.49 Definition regulatory authorities

KOFAM: Coordination portal for human research – see in particular

  • Online wizard for risk categorisation

Swiss Law

ClinO – see in particular articles 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
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CE – Conformité Européenne
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • EU – European Union
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • KOFAM – Coordination Office for Human Research
  • MD – Medicinal Device
  • MP –de Medicinal Product
  • SP-INV – Sponsor Investigator
Development ↦ Management ↦ Study Approval ↦ Swissmedic
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Statistic Methodology
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Statistic Methodology
Set-Up Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Statistic Methodology
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistic Methodology
Completion Drug or Device
Current Path (click to copy): Development ↦ Management ↦ Study Approval ↦ Swissmedic

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