Health Canada Policy Position On Autologous Cell Therapy Products
Because autologous cell therapy involves the use of a patient’s own cells, it can lead to assumptions that these therapies present minimal to no risk to recipients or that they would not be subject to the regulatory oversight given to drugs or other treatments. Some physicians may assume that autologous cell therapies are not governed by the Food and DrugRegulations – particularly when a cell therapy product involves less complicated processing steps, such as those prepared in a clinical setting using authorized medical devices. There is further uncertainty surrounding the practical means of meeting federal product safety regulatory requirements for cell therapies that aren’t mass produced; and, for this reason, how safe and effective products can be accessed by Canadians.
As part of its commitment to work with cell therapy stakeholders with a view to enabling these technologies to advance, Health Canada is working to address these issues from a federal regulatory perspective.
Statement 1: Autologous cell therapy products meet the definition of “drug” and persons who prepare (manufacture) and administer (distribute) them must comply with sections 8 and 11 of the Food and Drugs Act.
Statement 2: Autologous cell therapy products, except lymphohematopoietic cells which have been minimally manipulated and are intended for homologous use in transplantation, like other new drugs, are regulated under the Food and Drug Regulations and must be authorized by Health Canada. As new drugs, they are subject to Division 8 of Part C of the Food and Drug Regulations, and as investigational drugs they are subject to clinical trial requirements under Division 5 of the Food and Drug Regulations. Clinical trialds authorized by Health Canada are the mechanism through which patients can have access to investigational products where much remains to be known about safety and efficacy.
Statement 3: Health Canada considers that there is the potential for life threatening or life altering risks from treatments with autologous cell therapies that have not been developed and studied in accordance with the Food and Drugs Act and the Food and Drug Regulations.
Statement 4: There exists confusion regarding the regulatory status of autologous cell therapy products that are processed using equipment that has an authorized medical device licence. Clarity is needed and Health Canada plans to develop separate criteria to address this issue. Regardless, a medical device licence for a piece of manufacturing equipment does not by default constitute authorization for cell therapy products that are processed using an authorized medical device. Unless a device has received Health Canada authorization for specific therapeutic indications for the cell therapy output, the pertinent Food and Drug Regulations requirements apply to the cell therapy manufacturer.
Statement 5: Health Canada is working to identify and overcome challenges specific to meeting regulatory requirements for the manufacturing and sale of autologous cell therapy products, including those prepared at the bedside. Policy interpretations of existing regulations will be pursued until regulatory amendments are clearly required, and it can be expected that cell therapy products will be authorised when evidence is presented to Health Canada that demonstrates a product is safe, of good quality, and efficacious.
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CDA Oasis Team