The competent Authority for clinical gene therapy trials in Switzerland is the Swiss Agency for Therapeutic Products (Swissmedic)
. The agency ensures that only high-quality, safe and effective medicines and medical devices are placed on the market in Switzerland according to the Swiss Law on Therapeutic Products
. A single application for a gene therapy clinical trial is submitted to Swissmedic and circulated to different agencies, including the Swiss Expert Committee for Biosafety (SECB)
, the Federal Office of Public Health (FOPH)
and, in case of an in vivo gene therapy clinical trial to the Federal Office for the Environment (FOEN)
. In parallel the application is submitted to the Ethics Committee.
A limited number of gene therapy clinical trials have been conducted in Switzerland. The Ordinance on Clinical Trials with Therapeutic Products describes the specific information that is required to obtain a consent for a clinical gene therapy trial. The positive opinion of all involved parties is required for Swissmedic to issue a Decision within 90 days after submission of the application.
(Last reviewed by the Competent Authority: 17 June 2011)