CATrialAuthorisation object

Competent Authority/-ies (CA)
Ethics committee(s)

Clinical trials on Medicinal Products of categories B and C

National CA

Yes

All clinical trials need to be registered in a national registry (Art. 64-67 KlinV/ClinO).
An official portal is expected to be available by the end of 2015; entries in www.clinicaltrials.gov will continue to remain acceptable in Switzerland.
More information is provided on the kofam website of FOPH.
Email: kofam(at)bag.admin.ch

Verordnung über klinische Versuche; KlinV (de)/ Clinical Trials Ordinance; ClinO (en)

Clinical trials of medicinal products are categorised into A, B or C (Art. 19 KlinV/OClin).
Category A trials are exempt from submission obligation (Art. 30 KlinV/ClinO).

NB! ! NB: Special submission requirements apply to clinical trials on:

(1) Gene therapy/ GMO clinical trials: Additional application documents for Category B and C clinical trials of gene therapy and of genetically modified or pathogenic organisms are required and provided in Annex 4(4) KlinV/ClinO.
Further respective guidelines, checklists and standard forms are provided on the Swissmedics website in section: Licenses > Clinical trials > Clinical trials on transplant products / gene therapy / genetically modified organisms.
Enter Link: "Swissedic_Clinical trials on transplant products / gene therapy / GMOS" https://www.swissmedic.ch/bewilligungen/00155/00242/00328/index.html?lang=en

(2) Radioactive substances, with regard to radiological protection for trial participants: The sponsor must submit the trial to the CA, the EC and, in addition, to the Radiological Protection Division of the Federal Office of Public Health (FOPH).
Link: "FOPH": http://www.bag.admin.ch/themen/strahlung/index.html?lang=en
Additional application documents for clinical trials of therapeutic products capable of emitting ionising radiation are required and provided in Annex 4(5) KlinV/ClinO.

(3) Combination trials on IMP(s) and transplant products (organs, tissues, cells) must also be additionally submitted to the BAG. Details for submission can be found on their website.
(Link: "BAG": http://www.bag.admin.ch/)