Regulation of Gene Therapy in Canada
Gene therapy research and trials are ongoing in the U.S., Canada and the world. There has been considerable progress in the legislation and regulation of gene therapy research. Since 1995, Canada has chosen to regulate gene therapy through its Food and Drugs Act, that is, gene therapy is overseen by the same regulation and legislation drugs and pharmaceuticals. To this day, gene therapies are considered "biologics" and are approved by, and tightly regulated by Health Canada under this act. Before marketing a gene therapy, the producer must receive a Notice of Compliance from the Health Canada Biologics and Genetic Therapies Directorate (BGTD), and in order to do so must submit rigorous and compelling scientific evidence proving benefit. Any future clinical trials must go through a clinical trials application with the BGTD. 
Regulation of gene therapy in america
In the United States, the Department of Health and Human Services (DHHS) has been charged with oversight of clinical trials. Two organizations within DHHS, the Office for Human Research Protections (OHRP) and the U.S. Food and Drug Administration (FDA), have specific authority described in the Code of Federal Regulations (CFR). All investigators, must comply with these regulations when conducting clinical gene therapy trials. The OHPR mandates that all research involving human subjects undergo Institutional Review Boards (IRB) review and approval. An IRB is charged with evaluating research risk to subjects and must approve research protocols and informed consent documents prior to beginning a study.