The ISSCR welcomes the new policy guidance from Health Canada that clarifies the regulation of autologous cell products in Canada. Last year, the ISSCR urged Health Canada to harmonize Canada’s regulations with the international community to prevent the premature marketing and commercialization of cell therapies whose safety and effectiveness have not yet been established in clinical trials. The new policy guidance aligns Canada’s regulations with the U.S. Food and Drug Administration’s 2017 Regenerative Medicine Framework and the Australian Therapeutic Goods Administration’s 2018 Autologous human cell and tissue product regulations.
“With this new policy guidance, Health Canada joins the growing list of regulators that have put businesses selling unproven stem cell-based interventions on notice that these practices cannot continue,” said ISSCR President Doug Melton. “The new guidance provides much needed regulatory clarity to assure patients that products cannot be legally sold in Canada until the completion of clinical trials to demonstrate the safety and effectiveness of the product. Health Canada must immediately initiate enforcement actions to protect Canadian patients from unproven stem cell clinics peddling snake oil.”
The ISSCR urges regulators around the world to ensure that all stem cell therapies are regulated as drugs or biologics. Stem cell therapies are complex products that must be rigorously tested through well-regulated clinical trials to demonstrate safety and effectiveness prior to regulatory approval.