Health Canada clarifies position on Platelet Rich Plasma treatments
- Starting date:
- July 26, 2019
- Type of communication:
- Information Update
- Source of recall:
- Health Canada
- New safety information
- General Public, Healthcare Professionals
- Identification number:
Last updated: 2019-08-26
OTTAWA – 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 Canada’s Policy Position Paper on Autologous Cell Therapy Products.
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.
- PRP is obtained by spinning a sample of the patient’s blood at high speed to separate the red blood cells from the plasma, and obtaining a platelet-rich plasma fraction or fibrin matrix.
- PRP is used under the practice of medicine or dentistry to promote wound healing, relieve joint pain or for cosmetic purposes.
What you should do
- Talk to your practitioner if you are considering PRP treatments.
- Report potential non-compliant sale, deceptive advertising, and unsanitary manufacturing of any drugs, including PRP by submitting a complaint to Health Canada using the online complaint form.
- Check Health Canada’s Recalls and Safety Alerts database for advisories on illegal health products that have been found on the Canadian market.
- Report any health product-related adverse reactions or complaints to Health Canada.
- Stay connected with Health Canada and receive the latest advisories and product recalls.