On June 17, 2026, Health Canada published the Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Shortages and Discontinuation of Sale of Drugs and Medical Devices) (the “Amending Regulations”), introducing amendments to the Food and Drug Regulations (“FDR”) and the Medical Devices Regulations (“MDR”). The amendments are designed to strengthen Health Canada's ability to anticipate, monitor and mitigate shortages of drugs and medical devices that may pose risks to patients and the healthcare system. For manufacturers, the amendments signal increased regulatory oversight of supply continuity and shortage management and provide Health Canada with additional tools to address actual and potential shortages.
What is Changing?
Expanded Authority Over Drug Shortages
One of the most significant changes is the expansion of Health Canada's authority to monitor and manage drug shortages.
Historically, the shortage framework applied primarily to prescription drugs, controlled substances, biologics and certain non-prescription drugs administered under the supervision of a healthcare professional. The Amending Regulations now give Health Canada greater flexibility to extend certain shortage-related authorities to additional categories of drugs where a shortage could present a risk to human health.
To support this approach, Health Canada may establish and maintain a list of drugs that can become subject to certain shortage-related requirements. As a result, products that have traditionally fallen outside the core shortage reporting framework could be brought within its scope without the need for further regulatory amendments.
While the amendments do not immediately expand reporting obligations for additional products, they create a flexible mechanism allowing Health Canada to respond more quickly to emerging supply risks. Over time, manufacturers of products that are not currently subject to the shortage framework may become subject to additional oversight if Health Canada determines that shortages of those products could present risks to human health. Manufacturers should therefore monitor developments in this area and consider whether existing supply-chain monitoring and compliance processes would support future reporting obligations.
New Authority to Extend Drug Expiry Dates
To provide additional flexibility during supply disruptions, the Amending Regulations introduce a new mechanism that allows certain drug expiry dates to be extended in appropriate circumstances. Under the new framework, Health Canada may extend the expiry date of specific lots of authorized drugs where doing so is necessary to prevent or alleviate a shortage and where sufficient evidence demonstrates that the product will continue to meet applicable safety, efficacy and quality requirements throughout the extended period.
This authority may allow products that would otherwise become unavailable to remain on the market for a longer period during shortage situations. Manufacturers should be prepared to provide stability, quality and other supporting data where Health Canada is considering an expiry date extension and may wish to assess whether existing stability programs would facilitate timely engagement with the regulator if shortages arise.
Enhanced Exceptional Importation Framework
The Amending Regulations further strengthen Health Canada's exceptional importation framework, which allows certain foreign-authorized drugs and medical devices to be imported and sold in Canada during shortage situations. The goal is to ensure that patients continue to have access to needed therapies and medical devices when domestic supply cannot meet demand.
Manufacturers operating in therapeutic areas vulnerable to supply disruptions should be aware that foreign-authorized alternatives may play an increasingly important role in shortage mitigation efforts. The amendments provide Health Canada with additional flexibility to manage exceptional importation measures, reinforcing the regulator's ability to address supply concerns through alternative sources when domestic supply is insufficient.
Changes to Drug Shortage and Discontinuation Reporting Requirements
The Amending Regulations revise several aspects of the existing shortage and discontinuation reporting framework.
Manufacturers must now notify Health Canada if they have not sold a drug in Canada for a period of twelve months. This requirement is intended to give the regulator greater visibility into products that may effectively have left the Canadian market, even where a formal discontinuation has not been declared.
Although many of these changes are technical in nature, they provide greater clarity regarding when reporting obligations are triggered and give Health Canada better visibility into actual and potential supply concerns, including products that may have effectively exited the Canadian market without a formal discontinuation.
The new twelve-month notification requirement is particularly noteworthy, as it may capture products associated with dormant DINs or limited commercial activity. Manufacturers should review existing portfolio management processes, inventory tracking systems and product lifecycle governance frameworks to ensure that prolonged periods of non-sale are identified and assessed for potential reporting obligations.
More broadly, manufacturers should ensure that regulatory affairs, quality, supply-chain and commercial teams are aligned on shortage identification, escalation and reporting procedures.
New Medical Device Shortage and Discontinuation Framework
The Amending Regulations also introduce important changes to the shortage and discontinuation reporting framework for medical devices.
Unlike most of the drug-related amendments, however, these changes will not come into force until June 17, 2027. Until then, the current reporting requirements remain unchanged.
Manufacturers, importers and distributors of medical devices should use this transition period to assess their reporting practices, update internal procedures and prepare for compliance with the new requirements.
Key Takeaway for Manufacturers
The Amending Regulations reflect Health Canada's growing focus on supply chain resilience and product availability as matters of public health. These measures are expected to increase regulatory scrutiny of shortage management. Manufacturers should consider whether their current systems are sufficient to monitor and identify potential shortages at an early stage and respond efficiently to Health Canada information requests.
The amendments signal a shift toward a more proactive and risk-based approach to shortage oversight. Manufacturers should consider whether their existing governance frameworks, forecasting capabilities, business continuity plans and supply-chain monitoring systems are sufficient to support timely identification, escalation and management of shortage risks.
Manufacturers should also ensure that documentation supporting shortage assessments, supply forecasts, inventory decisions and communications with Health Canada is maintained and readily accessible. As Health Canada continues to expand its oversight of product availability, organizations that can demonstrate robust internal controls and effective cross-functional coordination will be better positioned to manage both compliance obligations and operational risks associated with shortages and discontinuations.
