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Current state of Health Canada regulation for cellular and gene therapy products: potential cures on the horizon.
Chisholm, Jolene; Ruff, Crystal; Viswanathan, Sowmya.
Afiliação
  • Chisholm J; Cell Therapy Program, University Health Network, Toronto, Ontario, Canada; Arthritis Program, University Health Network, Toronto, Ontario, Canada.
  • Ruff C; 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.
  • Viswanathan S; 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.
Cytotherapy ; 21(7): 686-698, 2019 07.
Article em En | MEDLINE | ID: mdl-31196821
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.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Transplante Homólogo / Terapia Genética / Terapia Baseada em Transplante de Células e Tecidos Tipo de estudo: Guideline / Prognostic_studies Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: Cytotherapy Assunto da revista: TERAPEUTICA Ano de publicação: 2019 Tipo de documento: Article País de afiliação: Canadá País de publicação: Reino Unido

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Transplante Homólogo / Terapia Genética / Terapia Baseada em Transplante de Células e Tecidos Tipo de estudo: Guideline / Prognostic_studies Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: Cytotherapy Assunto da revista: TERAPEUTICA Ano de publicação: 2019 Tipo de documento: Article País de afiliação: Canadá País de publicação: Reino Unido