OTTAWA, July 26, 2019 /CNW/ - In follow up to Health Canada's communication on unauthorized stem cell therapies on May 15, 2019, Health Canada would like to clarify for patients and practitioners that Platelet Rich Plasma (PRP) treatments, including Platelet Rich Fibrin treatments, are not the same as cell therapies and, as a result, are not subject to Health
PRP meets the definition of a "drug" under the Food and Drugs Act. The preparation of PRP falls under the scope of the practice of medicine and dentistry and is regulated provincially and territorially when it is a) conducted by "practitioners," including physicians and dentists; b) obtained from a patient; and c) administered back to the same patient in a single procedure. Anyone who wishes to sell PRP outside of these conditions must receive authorization from Health Canada, either through a clinical trial or drug authorization.
A "practitioner" is a person who is entitled under the laws of a province or territory to treat patients with prescription drugs in that province or territory. These are the only practitioners that are permitted to prepare and administer PRP.
To date, Health Canada has not received any applications to market PRP nor conduct clinical trials. As a result, the Department has not reviewed scientific evidence on the safety, efficacy and quality of PRP for any therapeutic uses.
Health Canada is responsible for enforcing the Food and Drugs Act, and can enforce matters related to non-compliant sale, deceptive advertising and unsanitary manufacturing of any drugs, including PRP. Health Canada will not hesitate to take action, as necessary, to protect the health and safety of Canadians.
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SOURCE Health Canada
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