News

Clinical trials on medicinal products for human use in the EU/EEA

The EU Clinical Trial Regulation (EU-CTR) will apply to clinical trials on medicinal products in the EU/EEA from 31 January 2022. The ClinO will continue to apply unchanged in Switzerland.

  • The legal provisions governing clinical trials on medicinal products for human use will change in the European Union and the European Economic Area (EU/EEA) from 31 January 2022. From this date, EU Regulation No. 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use (Clinical Trial Regulation EU-CTR) will apply.
  • This change has no direct impact on the conduct of clinical trials with medicinal products in Switzerland, where the Clinical Trials Ordinance (ClinO, SR 810.305) will continue to apply.
  • The existing electronic information systems operated by the Swiss enforcement authorities (cantonal ethics committees and Swissmedic where applicable) should continue to be used to submit applications for clinical trials on medicinal products in Switzerland.
  • Some modifications in line with the EU-CTR will be considered when the implementing ordinances relating to the Human Research Act are revised.

You can find further information regarding the EU-CTR on the website of the Federal Office of Public Health (FOPH).

Reports on the activities of the ethics committees and human research 2020

The coronavirus pandemic had an impact on human research projects in 2020, as shown by the activity report of the ethics committees. Besides the increased volume of research projects submitted for review, the cantonal ethics committees also encountered the following specific features:   

  • switch to remote working from home;
  • the associated challenges and solutions in examination and approval practice (e.g. online circulation processes for efficient application handling);
  • approval of an eConsent approach for facilitated granting of electronic (instead of paper-based) consent by subjects in difficult epidemiological circumstances;  
  • processing times for examining and approving applications, which were maintained compared with previous (pre-pandemic) years, and in the case of coronavirus-related applications, were even significantly reduced.

The impact of the pandemic can also be seen in the ‘Statistical report on Human Research in Switzerland 2020’, which contains detailed information and comparisons between COVID-19 projects and non-COVID-19 projects and between the pandemic year of 2020 and previous years. The analyses compiled in collaboration with swissethics and the Basel Clinical Trials Unit (CTU) on the basis of BASEC data (Business and Administration System for Ethics Committees) show, among other things, that: 

  • of a total of 3,033 applications submitted in 2020, 420 (just under 14%) were for COVID-19-related or SARS-CoV-2-related projects;
  • the ethics committees in French- and Italian-speaking Switzerland received proportionally more COVID-19 applications than the other ethics committees, and that the ethics committee in Ticino saw the total number of applications submitted double compared with the previous year;
  • in the month following the first confirmed SARS-CoV-2 infection in Switzerland, a significant number of projects were submitted, and this cluster of applications did not decline again until August 2020;
  • the larger number of applications compared with previous years – there were 24% more applications than in 2019 – was not only due to research projects related to COVID-19 or SARS-CoV-2, but to other, non-COVID-19-related projects.

Human research

Key points in a nutshell

A brief summary of the key points on human research in Switzerland


Applications & procedure

Requirement to obtain authorisation, categorisation and submission of applications

All information on the requirement to obtain authorisation, categorisation and submission of applications is available here:


SNCTP Portal

Search for studies

Search for registered clinical trials in Switzerland.

Categoriser

Online wizard for categorising human research projects

The categoriser provides help in assigning and categorising your research project according to the provisions of the Human Research Act – good preparation for the submission of your application!

Case studies

A selection of real human research projects

The case study module provides a selection of real human research projects, each with a brief summary. The projects can be filtered according to various criteria.