The competent authority for clinical trials of gene therapy and their approval is Swissmedic.
For questions regarding the submission of clinical trials, please contact: Swissmedic, clinical trials
In gene therapy, specific genes are inserted into the cells of an individual to try to cure diseases. Gene therapeutic intervention distinguishes between intervention in body or somatic cells (somatic gene therapy) and modifications to the human germline, i.e. sperm or eggs (germline gene therapy). This latter is prohibited in Switzerland. Clinical trials of gene therapy and authorisations have to be approved by Swissmedic.
Somatic gene therapy is divided into in vivo and ex vivo gene therapies.
- In vivo gene therapy trials, i.e. trials in which the genes to be transferred are directly inserted in the patient's body by means of vectors, are governed by the Federal Law on Therapeutic Products which came into force on 1 January 2002, and specifically by the Ordinance on Clinical Trials in Human Research. The Swiss Agency for Therapeutic Products (Swissmedic) is responsible for approving experimental gene therapy and also submits the dossier for consideration to the SECB, the Federal Office for the Environment (FOEN) and the Federal Office of Public Health (FOPH). The SECB issues Statements on the biological safety of the preparation for the proband as well as for human beings and the environment in general.
- Ex vivo gene therapy trials i.e. trials in which the therapeutic gene is transferred in vitro to cells or tissue before insertion in the patient's body, are governed by the Federal Ordinance on Transplantations and the Federal Ordinance on Xenotransplantations, and require approval by the FOPH. The SECB is also requested to issue Statements in this regard.
In addition, approval for gene therapy trials requires the consent of the local ethics committee.
The guidelines of Good Manufacturing Practice (GMP) in accordance with the European Guide to Good Manufacturing Practice (1997) must be observed for the manufacture of gene therapy products.