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
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.ctc.usz.ch
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