Stem Cell Therapy Regulation in Canada: Implications of the Prochymal Approval

On May 17, 2012, Health Canada issued marketing approval for Prochymal, a stem cell therapy used to treat children with acute Graft versus Host Disease (aGvHD). The development was heralded as the first stem cell product approved by regulatory authorities in the world.

In this case, Health Canada outpaced the USFDA, which is still requesting further clinical data from the manufacturer, Osiris Therapeutics Inc.

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