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. A single application is entered and is circulated to different agencies, including to the Federal Coordination Centre for Biotechnology of the Bundesamt für Umwelt (BAFU). A limited number of gene therapy trials have been conducted in Switzerland. The Verordnung über klinische Versuche mit Heilmitteln describes the specific information that is required to obtain a consent for a clinical gene therapy trials. The opinion of BAFU is required for Swiss Medic to issue a consent.
