News
Information on the coronavirus: new and updated document “Guidance of Swissmedic and swissethics on the management of clinical trials with medicinal drug products in Switzerland during the COVID-19 pandemic”
26.03.2020
The spread of the new coronavirus (SARS-CoV-2) also poses a major challenge for clinical trials of medicinal products in Switzerland.
Swissmedic and swissethics have therefore published a joint document ("Joint Guidance of Swissmedic and swissethics on the management of clinical trials with medicinal drug products in Switzerland during the COVID-19 pandemic"), which describes the most important recommendations for the treatment of patients in clinical trials of medicinal products. The document can be viewed on the respective Swissmedic and swissethics websites.
Information on the corona virus
24.03.2020
Please consult the dedicated COVID-19 website on swissethics.ch for news on the corona virus, guidance documents on the conduct of clinical trials and research projects in Switzerland, and other information. The COVID-19 website is updated regularly with new information, as it becomes available.
To promote transparency and facilitate the coordination of research on COVID-19, swissethics now publishes all approved and all submitted clinical trials and research projects on the dedicated COVID-19 website. Researchers are kindly asked to find out which projects are already underway in order to avoid national duplications. Should you oppose to that, please contact swissethics at info@swissethics.ch before you submit the project.
Information on the coronavirus
18.03.2020
Sponsors, investigators and project leaders of clinical trials and research projects in Switzerland must ensure that the studies are conducted in line with the COVID-19 Ordinance 2 (available in German (PDF), French (PDF) and Italian (PDF), issued by the federal government on 16 March 2020.
In particular, participants over the age of 65 and participants with underlying medical
Read moreInformation on the corona virus
16.03.2020
The corona virus also does not stop at the ethics commissions. Not all the scheduled committee meetings can be held regularly at the various locations. This means that there may be delays in the decision-making process and therefore deadlines cannot always be met. The ethics committees thank you for your understanding.
Nevertheless, the reviews and approvals of studies investigating the disease or investigational medicinal products for COVID-19 are of course treated with priority.
We thank you for your cooperation in this critical situation. In individual cases, the ethics committees are available to answer questions on this matter directly.
Quality assurance, or research project subject to approval?
04.02.2020
Sometimes it is not really clear when submitting an application whether it is a research project to be approved by the ethics committee or a pure quality control, which according to the HRA is not subject to approval and therefore does not have to be submitted to the ethics committee.
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