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Cytotherapy. 2019 Jun 10. pii: S1465-3249(19)30041-6. doi: 10.1016/j.jcyt.2019.03.005. [Epub ahead of print]

Current state of Health Canada regulation for cellular and gene therapy products: potential cures on the horizon.

Author information

1
Cell Therapy Program, University Health Network, Toronto, Ontario, Canada; Arthritis Program, University Health Network, Toronto, Ontario, Canada.
2
International Society for Cellular Therapy North American Legal and Regulatory Affairs Committee (NA LRA), Vancouver, British Columbia, Canada; Illumina Cambridge Ltd., Cambridge, UK; DRI Biotechnologies, London, UK.
3
Cell Therapy Program, University Health Network, Toronto, Ontario, Canada; Arthritis Program, University Health Network, Toronto, Ontario, Canada; International Society for Cellular Therapy North American Legal and Regulatory Affairs Committee (NA LRA), Vancouver, British Columbia, Canada; Institute of Biomaterials & Biomedical Engineering, University of Toronto, Toronto, Ontario, Canada. Electronic address: sowmya.viswanathan@uhnresearch.ca.

Abstract

We provide an overview of the regulatory framework, pathways and underlying regulatory authority for cell, gene and tissue-engineered therapies in Canada. Canada's regulatory approach uses three sets of regulations, namely, the Cells, Tissues and Organs Regulations, the Food and Drug Regulations and the Medical Devices Regulations. We provide an overview of each these sets of regulations as they apply to clinical investigation to post-market product lifecycle stages. Information is provided on the current sources of relevant Health Canada guidance documents. We highlight several regional success stories including Prochymal, a cell therapy product that achieved Canadian regulatory approval using the conditional marketing approval system. We also examine the perceived gaps in the Canadian regulations and how those gaps are being addressed by interactions between the government, stakeholders and international bodies. We conclude that the risk-benefit approach used by Health Canada for regulatory approval processes is sufficiently flexible to enable to development of novel cell and gene therapy products in Canada, yet stringent enough to protect patient safety.

KEYWORDS:

Health Canada; advanced therapies; cell therapy; gene therapy; market approval; medicinal products; regenerative medicine; regulation; tissue engineering

PMID:
31196821
DOI:
10.1016/j.jcyt.2019.03.005

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