What is it? Why is it important?

Main foreign agencies are 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?

As a SP-INV in Switzerland planning an international study, requires that the study be submitted and approved both in:

  • Switzerland by the Ethics Committee and if applicable Swissmedic (e.g. for risk category B and C studies) and the Federal Office of Public Health (FOPH)
  • Abroad by an applicable foreign agency according to the respective regulatory requirements depending on the participating countries


Submission and approval regulations outside Switzerland can be significantly different. Ask support from your local CTU or international partners. As a SP-INV, keep in mind to have a legal representative as applicable by foreign law.

Where can I get help?

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


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

MHRA – see in particular topics

  • Clinical trials and investigations detailed information
  • Medical devices regulation and safety detailed information

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
  • 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
  • SP-INV – Sponsor Investigator
Basic ↦ Ethics and Laws ↦ Authorities ↦ International

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Basic ↦ Ethics and Laws ↦ Authorities ↦ International

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