The following is Health Canada's statement to W5 on phage therapy
Health Canada is the federal regulator of therapeutic products in Canada. Phage therapy is considered a drug therapy regulated under the Food and Drugs Act and its Regulations and is used to treat infections caused by antimicrobial-resistant bacteria.
To date, the Department has not authorized any phage therapies in Canada.
Patients can obtain phage therapy in Canada on an experimental basis through a physician. If a physician wishes to use phage therapy to treat antimicrobial-resistant infections in a patient, the physician would be required to file a clinical trial application with Health Canada.
The application could either be as a conventional clinical trial or as an open-label individual patient study (OLIP). A conventional clinical trial involves comparing a drug against a placebo or another drug in large groups of people; an OLIP facilitates access to an investigational treatment (e.g., phage therapy) intended to treat a specific individual, for whom other treatment options have been exhausted and for whom other access methods, such as the Special Access Program or a traditional clinical trial, are not possible.
Although physicians and clinical trial investigators have contacted Health Canada for information and expressed an interest in conducting a clinical trial in Canada, the Department has not yet received any clinical trial applications for phage therapy for use in a clinical setting.
