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.

Health Canada/BIOTECanada Summit on regulatory and clinical topics related to subsequent entry biologics (biosimilars), Ottawa, Canada, 14 May 2012.

In May 2012, Health Canada and other participants held a National Summit on Subsequent Entry Biologics (SEBs). Health Canada released a guidance document in March 2010 describing policy positions and data requirements for approval of SEBs. While Health Canada and health agencies in other regulatory jurisdictions are aligned on many scientific principles related to biosimilar drugs, Health Canada's specific requirements may not be widely understood by many Canadian stakeholders. The Summit provided an opportunity for education and dialog among physicians who prescribe biologics, provincial payers, and industry on the following topics: preclinical and clinical comparability studies; manufacturing and other product differences; extrapolation of indications; substitution and interchangeability of SEBs with reference biologic drugs in clinical practice; payers' current perspective; pharmacovigilance and naming. It is anticipated that the consensus reached at this meeting will further educate Canadian healthcare professionals, provincial payers, and insurers about the appropriate use of SEBs, and may be of general interest to others internationally.