Personalized Medicine in Cancer: An Overview with Chimeric Antigen Receptor Therapy and Health Canada Regulatory Insights

Health Canada and the FDA have adapted regulatory frameworks to balance innovation and safety in CAR-T therapy, from revising risk management strategies to enforcing manufacturing standards. However, gaps in post-market surveillance, real-world data, and equitable access persist. Enhancing surveillance systems, investing in infrastructure, and fostering regulatory collaboration can unlock CAR-T’s potential while mitigating risks, redefining cancer treatment in Canada and beyond.