UPDATE: On December 28, 2024, Health Canada published proposed related amendments to the Food and Drug Regulations and Medical Devices Regulations.
On June 25, 2024, Health Canada published a notice of intent and Building resilience: Health Canada’s plan to address health product shortages, 2024 to 2028, relating to Health Canada’s plan over the next 4 years to address health product shortages, including proposed amendments to the Food and Drug Regulations and Medical Devices Regulations. The consultation on both was open until July 25, 2024. Amendments to the regulations will be published in the Canada Gazette Part I this fall for additional comment.
Health Canada’s plan includes measures for (1) identifying and addressing shortage risks; (2) enhancing and sharing supply chain information (for example, by enhancing regulatory responses and reporting requirements); and (3) improving access to health products by modernizing regulatory frameworks.
As stated in the notice of intent, the proposed measures in the amendments to the regulations would help prevent shortages of drugs and medical devices for human use, and reduce the impacts of shortages that cannot be prevented.
The proposed amendments to the Food and Drug Regulations include:
- applying the regulations that deal with shortages to additional drugs or classes of drugs
- expanding the use of the exceptional importation framework
- allowing the exceptional sale of a foreign-authorized, domestically manufactured drug to address a shortage, and
- requiring manufacturers to ensure that 3 months of safety stock is maintained in Canada for drugs that are critical and vulnerable to shortage, based on historical demand.
The proposed amendments to the Medical Devices Regulations include:
- using the exceptional importation framework in a more targeted way to help reduce safety risks, such as by specifying that the framework can be used to address a shortage or a risk of a shortage that could cause harm, and
- requiring importers to notify Health Canada when the foreign authorization of an exceptionally imported medical device is suspended or cancelled.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance 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.