News
Possible problems with clinicaltrials.gov due to US government shutdown: alternative trial registries
17.10.2025
According to reports from Swiss researchers, since 1 October 2025 there have been problems with new registrations and updates to existing registrations of clinical trials on clinicaltrials.gov due to the US government shutdown.
Read moreSwissmedic is conducting a pilot project to reduce the processing time for applications
17.07.2025
On July 1, 2025, Swissmedic launched a pilot project to reduce the processing times for applications for clinical trials with medicinal products under certain conditions. This pilot project applies to clinical trials that meet at least one of the following criteria:
Read moreUpcoming fee changes from July 1, 2025
17.06.2025
Please be advised of the following important change. From July 1, 2025, the fees charged by the ethics committees for the assessment of applications and requests submitted will be increased by 5%.
Read moreswissethics is looking for a projekt manager and serving as deputy managing director (60-80%)
26.05.2025
swissethics is looking a projekt manager and serving as deputy managing director (60-80%), starting September 1, 2025 or at later date.
The job offer is published here.
Annual safety and general progress trial report for clinical trials with medical devices
05.05.2025
As announced on February 18 (see News 18.2.2025 below), swissethics is today publishing a new template for writing the annual safety and general progress trial report for clinical trials with medical devices.
Read moreArtificial Intelligence and research involving human beings: Issues to consider when submitting a project to a research ethics committee
17.04.2025
swissethics published a guiding document on issues to consider when submitting a project on artificial intelligence (AI) to a research ethics committee. The purpose of this document is to support research involving AI through a set of indicative questions outlining the basic AI-specific issues that ethics committees expect to be covered in research protocols.
Read moreElection of the President and Vice-Presidents at the General Assembly on March 18
25.03.2025
At the general assembly, Dr. Susanne Driessen, St.Gallen, was re-elected as president of swissethics. Three new vice-presidents were elected: Prof. Dr. Maja Beck Popovic, Lausanne, Dr. med. Beatrice Giberti Gai, Bellinzona and MLaw Regula Steiner, Bern.
Read moreGCP-courses recognition by swissethics: Adaptation to the Principles and Annex I of the revised ICH E6(R3), to the Declaration of Helsinki and to ISO/DIS 14155
25.02.2025
swissethics reminds GCP course providers to update their courses to the Principles and Annex 1 of the revised ICH E6(R3), to the updated Declaration of Helsinki of October 2024, and to ISO/DIS 14155 «Clinical investigation of medical devices for human subjects – Good clinical practice».
Read moreAdoption of ICH Guideline E6(R3)
24.02.2025
On 6 January 2025, the Principles and Annex 1 of the revised ICH Guideline E6(R3) were adopted at the international level. They will come into effect in the EU region on 23 July 2025. In line with this schedule, the Principles and Annex 1 are also to come into effect in Switzerland in summer 2025. Annex 2 will be adopted at a later date, coming into effect in the EU and in Switzerland no earlier than the beginning of 2026.
Read moreAnnual Safety and General Progress Trial Report
18.02.2025
swissethics publishes a new template for writing the Annual Safety and General Progress Trial Report. The report must be submitted to the competent ethics committee as per the revised article 43 ClinO. The report is submitted once yearly. The start of the submission of the progress report is the date of approval of the clinical trial. The template for clinical trials of medical devices according to ClinO-MD will be published at a later date.