Health Canada's full statement on phage therapy
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.