On December 28, 2024, Health Canada published a regulatory proposal in the Canada Gazette, Part I, Volume 158, Number 52, introducing amendments to the Food and Drug Regulations, CRC, c 870 and the Medical Devices Regulations, SOR/98-282, under the Food and Drugs Act, RSC 1985, c F-27. This proposal comes in response to increasing challenges posed by drug and medical device shortages, which have been exacerbated by global supply chain disruptions and public health crises. These changes are designed to address the challenges posed by shortages of drugs and medical devices in Canada and to better protect people in Canada from the harms posed by certain therapeutic product shortages.
Stakeholders and the public can submit comments to Canada Gazette, Part I until March 8, 2025, at 11:59 PM EST.
Objectives of the Proposed Amendments
These amendments aim to enhance reporting frameworks; strengthen compliance measures; ensure better preparedness for potential shortages; and provide Health Canada and its regulated parties, stakeholders, and provincial/territorial partners with more and better tools to prevent, mitigate, and respond to drug and medical device shortages. These changes also aim to improve the quality of, and user experience for, existing administrative processes such as drug and medical device shortage reporting and applications for exceptional importation.
Overview of the Proposed Amendments
For drugs, the proposed amendments would introduce:
- Safety Stock Requirements: Market authorization holders will be required to maintain adequate supplies of select drugs where a shortage could pose a serious and imminent risk to human health.
- Shortage Prevention Measures and Mitigation Plans: Market authorization holders will be required to develop and maintain plans to address shortages for drugs that could present serious health risks.
- Reporting Demand Surges: Drug importers and wholesalers will be required to report significant demand increases to the Minister of Health for drugs where a shortage could present a serious risk of injury to human health.
- Expanded Scope of Regulation: The Minister of Health will have the authority to expand the scope of drugs subject to shortage regulations and require information be provided on shortages of a wider range of drugs in certain circumstances.
- Expiration Date Extensions: The Minister of Health will have the discretion to extend the expiration dates of Canadian-authorized drugs during shortages to increase supply availability.
For both drugs and medical devices, the proposed amendments would introduce:
- Exceptional Importation Framework Updates: The framework for exceptional importation and sale will be updated to cover a broader range of circumstances, with a focus on mitigating safety risks.
- Improved Reporting Frameworks: Enhanced regulations will ensure better reporting of drug and medical device shortages and discontinuations.
Health Canada is publishing both new and updated draft guidance to assist regulated parties in understanding and responding to the amended regulatory requirements. This includes guidance for reporting shortages and discontinuations of drugs and medical devices and guidance related to exceptional importation and sale of drugs and medical devices.
Implementation timeline
The proposed amendments will be rolled out in three phases to allow stakeholders time to adapt to their implementation:
- Amendments in Force Six Months After Publication in Canada Gazette, Part II:
- Minister’s authority to expand the scope of drugs subject to shortage regulations;
- Minister’s authority to extend expiration dates for drugs to address shortages; and
- Updates to exceptional importation and sale frameworks for drug and medical devices.
- Amendments in Force Twelve Months After Publication:
- Requirement for drug market authorization holders to maintain shortage prevention and mitigation plans; and
- Requirement for importers and wholesalers to report demand surges in certain circumstances;
- Updates to reporting frameworks for drug and medical device shortages and discontinuations.
- Amendments in Force Eighteen Months After Publication:
- Requirement for drug market authorization holders to maintain safety stocks in certain circumstances.
The phased implementation timeline allows stakeholders time to adapt to the new requirements. However, Health Canada will provide additional resources, including training and guidance documents, to ensure smooth adoption and compliance.
Enforcement approach
Compliance will be assessed under Health Canada’s Compliance and enforcement policy for health products (POL-0001), which employs an evidence- and risk-based strategy. Such an approach promotes fairness, consistency, impartiality, and transparency to both help protect public safety and prevent deception that would create a false or misleading impression of health products amongst people in Canada.
Enforcement measures may include compliance promotion activities, targeted oversight of risks through proactive compliance monitoring, and the utilization of rapid response and enforcement to address detected public health risks.
In addition to the measures outlined, Health Canada will collaborate with industry stakeholders to promote understanding and adherence to the new regulations, including conducting regular audits and evaluation activities to assess the effectiveness of Health Canada programs, including the department’s Health Product Shortages Program.
Next Steps: Public Consultation
Stakeholders and the public can submit comments to Canada Gazette, Part I. All comments will be posted online after the consultation period closes. The consultation period is open for 70 days, ending on March 8, 2025, at 11:59 PM EST.
The input gathered through this consultation process will help Health Canada:
- Design systems and procedures that promote readiness and a rapid response to shortages;
- Detect when there is a risk of a shortage and intervene to help avoid the shortage before it happens; and
- Detect early shortage signals to minimize their impacts when they occur and restore access to needed products quickly.
[View source.]
