WebAug 3, 2015 · Regulations for cell therapies: cells, tissues & organs for transplantation. Minimally manipulated allogeneic cells, tissues and organs that meet certain criteria fall under the CTO regulations []; no specific evidence of efficacy need be provided to Health Canada under these regulations.Minimal manipulation is defined as processing that …
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WebThe CTO Regulations apply to all individuals and establishments that handle, process, distribute or import human organs, or minimally manipulated cells and tissues for homologous use, for transplantation in another individual in Canada. In order to fully comprehend these Regulations, the Food and Drugs Act (F&DA) as well as the most … WebAlthough the CTO Regulations exclude investigational products and autologous cell therapies from their scope, infectious disease screening and testing principles, labelling, as well as principles for quality systems contained within the Regulations are applicable to all therapies involving the use of human cells. cu ballet sleeping beauty
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