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

3. Fast-Track Pilotprojekt

The Fast-Track Pilot Project aims to significantly reduce the processing times for applications for clinical trials with medicinal products under certain conditions. The aim is to accelerate the development of innovative therapies and enable faster access to potentially life-saving treatments, especially when there is a high medical need. The pilot phase will start on 1 July 2025 and offer the pharmaceutical industry and research institutions the opportunity to efficiently advance promising projects.

At least one of the following criteria must be met:

1. High medical need: Trials addressing therapies for serious or life-threatening diseases for which there are no approved treatment options in Switzerland.
2. Known investigational medicinal products: Clinical trials testing active substances, combinations of active substances or investigational products that have already been reviewed and authorised by Swissmedic in previous clinical trials in Switzerland.

Fast-track processing is limited to initial applications for authorisation of a clinical trial with medicinal products. Applications for amendments are excluded from fast-track processing.

The following applications are also not eligible for fast-track processing:

• Clinical trials with the following products: medical devices, advanced therapy medicinal products, complementary and herbal medicinal products
• Complex clinical trials
• Combined trials of medicinal products and medical devices/in vitro diagnostic devices
• Radiopharmaceuticals
• Temporary authorisations
• Other clinical trials, ClinO Chapter 4

Registration as a fast-track application:

• Applications for high medical need must be submitted for preassessment with Swissmedic for review of the criteria.

Preassessment procedure:

a.     Complete the application form: Application Form Fast Track (DOCX, 372 kB, 23.07.2025)

b.     Submit the accompanying letter and protocol synopsis together with the application form as follows:

i.     By post: CD/DVD with the documents in the eDok folder structure, application form under 00F

ii.     Portal: Portal zip file with the documents in the eDok folder structure, application form under 00F

Submission as new delivery – Case type = application for new case/authorisation

During the preassessment, Swissmedic checks whether the criterion of ‘high medical need’ is met. Once this has been completed, Swissmedic forwards its decision (confirmation as fast track or rejection) to the applicant, who can then submit the actual application as a new clinical trial in the usual manner.

• Applications for known investigational medicinal products can be submitted as normal, without advance submission for preassessment.

a. Complete the application form: Application Form Fast Track (DOCX, 372 kB, 23.07.2025)

b. Submit the application as normal as a new clinical trial. File the Fast Track application form under 00F, in addition to the KLV application form

c. Upon receipt of the application, Swissmedic will check whether the criterion of ‘known investigational medicinal product’ is met during the formal review.

Application processing by Swissmedic

The processing of new clinical trials that meet the fast-track criteria is faster than the deadlines specified in the ClinO:

• Applications pursuant to Art. 33 para. 2 are processed within 20 days instead of 30 days.
• Applications pursuant to Art. 33 para. 3 are processed within 40 days instead of 60 days.

The shortened deadlines in the fast-track procedure are not legally binding, but represent a performance promise by Swissmedic. Swissmedic makes every effort to meet these deadlines, but delays may occur in exceptional cases.