Submission of applications

1. All information on the technical requirements for the submission of applications* for clinical trials for medicinal products is provided here:

*These include

• Clinical trials with medicinal products
• Clinical trials with ATMP (advanced therapy medicinal products, such as transplant products, gene therapy products, somatic cell therapy products, products with genetically modified organisms)
• Complex clinical trials
• Applications for temporary licences to use medicinal products in accordance with Art. 9b para. 1 TPA
• Plus all submissions during the execution of the trials, such as
  • changes
  • reports
  • reporting of matters such as suspected unexpected serious adverse reactions (SUSAR)

2. Fee reduction for academic clinical trials

Sponsors of clinical trials with medicinal products, medical devices and novel therapies that are not financed by commercial third-party funding may apply for a fee reduction. Fees will be reduced by 80% for the processing of applications and reports in the context of such clinical trials. This reduction is based on Art. 12 of the Ordinance on the Fees charged by the Swiss Agency for Therapeutic Products (FeeO-Swissmedic [SR 812.214.5])

If possible, please submit the documents for the fee reduction application together with your new request (CTA). If the clinical trial is already underway, please submit the application together with your next change request or separately as a pure "Administrative Change". The reduction does not apply retrospectively to fees already charged for a trial. For applications that are already being processed, the reduction will be taken into account provided that the processing status allows this.

Application for a fee reduction for clinical trials with medicinal products and ATMPs**

1. Complete the application form: [Application form]

2.  Attach the signed self-declaration to the application form (according to [template (DOCX, 366 kB, 01.07.2024)])

3.  Submit the application form and the self-declaration with a submission form completed as follows (FO submission form) as follows:

a. Submission Type: 2. SUBMISSION to an AUTHORISED Clinical Trial

b. Reason for Amendment / Submission: "Request for fee reduction" (manual entry)

c. Select Form Type: 2.1 CHANGE

d. Please select from topics: Other Administrative Change

e. No selection for: “Change of Contact Persons or Contact Details”

4. The two forms and the signed self-declaration must be filed in folder "00F" as per the eDok structure.

Change in funding source(s): If a clinical trial subsequently receives partial or full commercial third-party funding during its implementation, this circumstance must be reported to Swissmedic immediately as an "Other Administrative Change", stating the relevant information under "Reason for Amendment / Submission".

**These include:

• Clinical trials with medicinal products
• Clinical trials with ATMP (advanced therapy medicinal products, such as transplant products, gene therapy products, somatic cell therapy products, products with genetically modified organisms)
• Complex clinical trials