In vitro diagnostic (IVD) medical devices - Clinical performance studies: Expected changes in the legal requirements and BASEC
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”
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 coronavirus
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
Information on the corona virus
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?
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.Read more
Changes to the project registry of swissethics
Since 2016, swissethics has regularly published clinical trials and research projects that have been approved by the competent ethics committees in Switzerland. The focus was on "ongoing" clinical trials and research projects (RoPS, Registry of ongoing projects in Switzerland).
From now on, all clinical trials/projects will be published. Consequently, those that have already been completed can also be found in the register. Thus, the registry has been renamed RAPS: Registry of All Projects in Switzerland