Health Canada announced a number of new and updated guidance documents and policies in September 2026, including the following.
Notifying Health Canada of foreign actions
Health Canada issued revised guidance on notifying Health Canada of foreign actions, effective October 1, 2026. The revised guidance clarifies the requirements to notify Health Canada of certain foreign regulatory actions specified in subsection C.01.050(2) of the Food and Drug Regulations in the specified foreign jurisdictions, which involve a serious risk of injury to human health and are relevant to the safety of the drug.
Summary reporting requirements
Health Canada issued updated guidance for summary reporting requirements for marketed drugs and natural health products, effective October 1, 2026. Key changes include clarifying that annual summary reports need only be provided upon written request from Health Canada, describing how to notify the Minister of significant changes to a product’s risk-benefit profile using a new form and setting out the threshold for notification.
Compliance & enforcement
Health Canada updated its Compliance and enforcement policy for health products (v 10), effective September 15, 2026. The policy describes Health Canada’s national compliance and enforcement approach for health products regulated under the Food and Drugs Act. Among other changes, the updated policy:
- updates the scope of products and activities covered;
- expands the guiding principles for Health Canada’s compliance and enforcement activities;
- clarifies roles and responsibilities for regulated parties, health care professionals, health care facilities, retailers and consumers; and
- describes additional enforcement actions.
Access Consortium joint reviews
Health Canada announced a pilot on September 14, 2026, allowing it to request new and updated safety and efficacy data during joint reviews with Access Consortium partners through the consolidated list of questions phase of the review cycle. The pilot applies to new and ongoing submissions under the New Active Substances Work-Sharing Initiative for innovator drugs and the Generic Medicines Work-Sharing Initiative for generics.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group or the Pharmaceutical Litigation Group.
The preceding is intended as a timely update on Canadian intellectual property and life sciences regulatory law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.