Switzerland

Switzerland

Swiss National Clinical Trials Portal (SNCTP)

Verified on September 9, 2021

Switzerland has a supplementary federal database, Swiss National Clinical Trials Portal (SNCTP). The regulation requires that sponsors must register their protocol in a World Health Organization (WHO) primary registry or ClinicalTrials.gov. SNCTP is not a WHO recognized primary registry. The sponsors must register the additional information than what is posted on WHO primary registry or ClinicalTrials.gov, in a Swiss national language on SNCTP as per Ordinance on Clinical Trials in Human Research. Posting protocol registration in SNCTP is mandatory. There is no provision for posting results.

Registries at a Glance
Registry PHUSE Categorization Information to be Entered By Route of Data in Registry Study Type Language
SNCTP National- or Registry that Supplements information from other Registries Sponsor Clinical Trial Application

Interventional

(phase 1 to 4)

Observational

German
French
Italian
English
BASEC Mandatory National Database (includes Ethics Requirement) Ethics Clinical Trial Application

Interventional

(phase 1 to 4)

Observational

German
French
Italian
English
Registration and Results Requirements
Registry Activity Legal Requirement Timing
SNCTP Registration

Yes

Phase 1 clinical trials: Up to 1 year after the completion of the clinical trial. Phase 2 to 4 clinical trials: Before the clinical trial starts.
Results

n/a

Not applicable (NA)
BASEC Registration

Yes

Phase 1 clinical trials: Up to 1 year after the completion of the clinical trial. Phase 2 to 4 clinical trials: Before the clinical trial starts.
Results

No

NA

Registry Updates


  • September 2021: Switzerland Update - New Application (VO) Form and New Format for Authorisation Applications and Changes/Notifications/Reports Regarding Clinical Trials with Medicinal Products as of 13 September 2021 According to an update posted by Swissmedic (Swiss Agency for Therapeutic Products), authorisation applications and changes/notifications/reports regarding clinical trials with medicinal products must be submitted to structure (“eDoc” structure), a new application … Continue reading "September 2021: Switzerland Update"
  • August 2021: CTIS Webinar Update - European Medicines Agency updated the Clinical Trials Information System (CTIS) webinar: How sponsor organisations can prepare for CTIS event page with details pertaining to the webinar that took place on July 29, 2021. It includes the following details provided for easy understanding of the working and functionalities of EU CTIS; Event Summary Documents inclusive of the agenda, … Continue reading "August 2021: CTIS Webinar Update"
  • August 2021- CTIS Highlights - The fourth issue of CTIS Highlights was published on August 06, 2021. It briefly discusses the new timeline for CTIS, confirming the go-live date of CTIS and the initial submission date followed by a three-year transition period for submission of ongoing trials through CTIS. Additionally, the newsletter spans over the training programme updates, CTIS Sponsor handbook details, … Continue reading "August 2021- CTIS Highlights"

References


  1. Ordinance on clinical trials with medical devices. https://www.fedlex.admin.ch/eli/cc/2020/553/de#chap_5. Published July 01, 2020. Accessed June 14, 2021.
  2. Medical device regulation. https://www.fedlex.admin.ch/eli/cc/2001/520/de. Published October 17, 2001. Accessed June 14, 2021.