SWITZERLAND Law and Practice Contributed by: Oliver Brupbacher, Markus Schott, Markus Wang, Djamila Batache and Christine Schweikard, Bär & Karrer AG
2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial In order to secure authorisation for the conduct of a clinical trial, the investigator must submit an application to the ethics committee in the canton in whose territory the study is conducted (Arti- cles 24 et seq of the ClinO and Articles 10 et seq of the ClinO-MD). This is followed by: • acknowledgment of receipt/possible deficien- cies’ notification within seven days (medicinal products) or ten days (medical devices); and • decision within 30 days (medicinal products) or 40 (medical devices) days and information of Swissmedic in the event that an authorisa- tion by Swissmedic is necessary – in case of multi-centre clinical trials with medicinal prod- ucts, the deadline is extended to 45 days. The submission of the application to Swiss- medic is made by the sponsor – following which: • acknowledgement of receipt/possible defi- ciencies’ notification within seven (medici- nal products) or ten (medical devices) days respectively; • as a general rule, decision within 30 days (medicinal products) or 45 days (medical devices); and • in certain circumstances, Swissmedic must obtain the opinions from the Swiss Expert Committee for Biosafety (SECB), the Fed- eral Office for the Environment (FOEN) or the FOPH before granting the authorisation. 2.3 Public Availability of the Conduct of a Clinical Trial Sponsors of authorised clinical trials with medic- inal products are subject to registration obliga- tions (Articles 64–67 of the ClinO). Before con- ducting a clinical trial with medicinal products, the sponsor must enter the clinical trial either
in a primary register recognised by the World Health Organization (WHO) or in the register of the National Library of Medicine of the United States of America as well as in the supplemen- tary Swiss federal (from March 2025: cantonal) database using a Swiss national language. The publicly accessible portal SNCTP (Swiss National Clinical Trials Portal) displays studies that are being conducted in Switzerland as soon as they have been approved by the cantonal eth- ics committee and released for publication by the researchers. The data originates from the cross-cantonal application submission platform BASEC (Business Administration System for Ethics Committees) and the international study database International Clinical Trials Registry Platform (ICTRP) (WHO database comprising 17 worldwide primary registers). The data listed in Annex 5 number 2.1 to 2.14 of the revised ClinO ( “revClinO” ) will be made automatically accessible to the public at the lat- est within six months from the grant date of the trial authorisation (Article 64 paragraph 5 of the revClinO). This will include a brief description of the clinical trial, the site(s) where the clinical trial is conducted, the criteria for the participation in the clinical trial, the disease category, and the health condition investigated, as well as an indi- cation of whether the clinical trial includes rare diseases. The Registry of All Projects in Switzerland (RAPS) of the Swiss Association of Research Ethics Committees ( “swissethics” ), the umbrella organisation of cantonal ethics committees, also publishes clinical trials that have been approved by an ethics committee. Sponsors of clinical trials must, in principle, reg- ister a summary of the results of the clinical trial
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