Clinical Trial Application

Here you will find useful information that will guide you through the Clinical Trial Application (CTA) process at Swissmedic. All Swissmedic requirements for a complete CTA dossier are listed in the guidelines published below.

Since 01.01. 2014, CTAs for categories B and C clinical trials can be made in parallel to Swissmedic and to the lead Ethics Committee (Category A clinical trials of therapeutic products are exempted from the requirement for authorisation from Swissmedic, art. 30 ClinO, RS 810.305). Both authorities review their respective dossier and issue separate approvals. The trial cannot start before both approvals have been obtained (art. 45 HRA, SR 812.21; art. 54 TPA, SR 812.21).

Format for submitting a new Clinical Trial Application:
Would you like to help protect our environment? Please comply with the submission format specified below. We regret that we will be obliged to dispose of any stationery, etc. that we did not specifically request.

Please submit all documents on paper and CD (including cover letter and application form) in accordance with our requirements. 

Format: One copy of each document (A4), punched and placed in the order described in the “Clinical Trial Application Dossier” Guideline, in a ring binder (2 perforations, spine width 7 cm) with a 20-tab numbered file divider (see below for binder colour).
Contents should be inserted in sections 1-10 in accordance with the instructions provided, while sections 11-20 must be left empty for official use. 

Please do not submit individual documents in pocket folders or loose-leaf binders.

Please use white ring binders when making submissions between December 2019 and November 2020.
The binder color for earlier submissions can be found here.

https://www.swissmedic.ch/content/swissmedic/en/home/humanarzneimittel/clinical-trials/clinical-trials-on-medicinal-products/clinical-trial-application.html