The regulation of cell therapy products in Canada.

This article provides a high level view of how cell therapy products are regulated in Canada and addresses the regulatory framework, pathways and underlying regulatory authority. The regulatory approach involves, primarily, two major sets of regulations; and the scientific basis for product categorization and the application of each of these pathways is discussed. Products that undergo more than minimal levels of processing, or meet certain other criteria, are regulated as biological drugs under the applicable parts of the Food and Drug Regulations. Other cellular products, primarily those for allogeneic transplantation and with an established therapeutic use, are regulated under the more recently promulgated Safety of Human Cells, Tissues and Organs for Transplantation Regulations, which incorporate a standards-based approach. Various concerns and challenges for these classes of products are discussed and information is provided on current sources of relevant guidance, including specific Health Canada guidance currently being developed. Health Canada strongly supports and participates in efforts aimed at international regulatory convergence and harmonization.