CASubmissionFee object

Fees for trial submission mandatory

Yes

Fees

Evaluation of Clinical Trials:
New Notification of clinical drug trial- new application: 1000.- CHF
Additional work for evaluation of answers after first review: 200.- CHF/ hour.
Notification of clinical trials with transplants: 1000.- CHF
Approval of ATMP clinical trials: 5000.- CHF
Approval of clinical trials on gene therapy with transplants containing GMOs: 2000.- CHF
Evaluation of Amendments of Clinical trials with
IMP, and other additional submissions: 200.- CHF/ hour
ATMP: 1000.- CHF
somatic gene therapy with transplants containing GMO: 5000.-
transplants: 200.- CHF
Response to extensive inquiries (not related to a submitted or approved study): 200.- CHF

Waiver for academic (non-commercial) studies possible

No

Official guidance on required fees

Fees are provided on Swissmedic website in section: Home > Licensing Clinical trials > Clinical trials on medicinal products > Clinical Trial Application.

Applicable national legal framework/ Reference

Heilmittel-Gebührenverordnung, HGebV (Ordinance on Fees levied by the Swiss Agency for Therapeutic Products), Appendix 5, version dated 01.01.2013. The document and external website are only available in German, French or Italian.

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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