What is it? Why is it important?

Main foreign agencies are for the:

  • European Union: the European Medicines Agency (EMA)
  • US: the Food and Drug Administration (FDA)
  • Canada: the Health Canada
  • United Kingdom: the Medicines & Healthcare Products Regulatory Agency (MHRA)

What do I need to do?

When planning an international study, you will be required to not only submit the study for approval in Switzerland (e.g. EC, Swissmedic, FOPH) but also to the applicable foreign agency.

Regulations outside Switzerland can be significantly different. Ask support from your local CTU or international partners.

Where can I get help?

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

References

EMA – see in particular topics

  • Human regulatory / Research and development
  • Human regulatory / Overview / Medical devices

FDA – see in particular topics

  • Drugs / Drug development and review process
  • Regulatory information / FDA Guidance Search / Search for FDA guidance documents
  • Medical devices / Device advice: comprehensive regulatory assistance / How to study and market your device

FOPH – see in particular topics

  • Medicine & Research / Research involving humans
  • Medicine & Research / Research involving human embryonic stem cells
  • Laws & Licences / Notifications and authorisations in the field of biosafety
  • Laws & Licences / Exceptional licences and licences for banned narcotics

Health Canada – see in particular topics

  • Drugs and health products / Drug products / Applications and submissions – Drug products
  • Drugs and health products / Medical devices / Legislation and guidelines – Medical devices

MHRA – see in particular topics

  • Clinical trials and investigations detailed information
  • Medical devices regulation and safety detailed information
Abbreviations
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • EMA – European Medicines Agency.
  • FDA – Food and Drug Administration
  • FOPH – Federal Office of Public Health
  • Health Canada – Canadian department of Health
  • MHRA – Medicines & Healthcare Products Regulatory Agency
Basic ↦ Ethics and Laws ↦ Authorities ↦ International
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): Basic ↦ Ethics and Laws ↦ Authorities ↦ International

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