On November 29, 2024, the Regulations Amending Certain Regulations Made under the Food and Drugs Act (Agile Licensing) were published in the Canada Gazette, Part 2. These amendments introduce a series of updates to the Food and Drug Regulations (the “FDR”) and the Medical Devices Regulations to modernize them, increase alignment with international regulatory schemes, codify existing Health Canada policies, and put in force new regulatory agilities piloted during the COVID-19 pandemic.

The key amendments are as follows:

  • Terms and conditions (“T&Cs”) on drugs and medical devices: T&Cs can be imposed by the Minister of Health (the “Minister”) on a drug or medical device to optimize its benefits and manage the risks and uncertainties associated with it. While T&Cs were previously used in relation to specific drugs and the testing of medical devices, the new amendments have expanded their scope of use to include all drugs, as well as matters related to medical devices other than tests. T&Cs can be imposed, amended, or removed at any time. When imposing T&Cs, the Minister must first consider whether less burdensome alternatives are available. Public health emergency drugs are already subject to T&Cs, with broader implementation being phased in over time (see timelines below).
  • Expanding and clarifying the use of Risk Management Plans (“RMPs”): An RMP identifies a drug’s potential risks and uncertainties and indicates how a manufacturer intends to manage them. The amendments related to RMPs codify pre-existing Health Canada guidance on their use. Under the amendments, RMPs are now required for certain new drug submissions, DIN applications, and supplements to new drug submissions. Additionally, for drugs already authorized for sale, the Minister may request an RMP – if one has not already been provided – when there is significant uncertainty regarding the drug’s risks or if the drug presents a serious risk of injury to human health and warrants measures beyond labelling to reduce the risk. New RMPs may also be requested for authorized drugs with existing RMPs if the risks are significantly different from those described or if the manufacturer’s intended risk management measures have changed significantly.
  • Expand public health emergency drug flexibilities: During the COVID-19 pandemic, regulatory flexibilities were introduced for establishment licensing activities and for the pre-positioning and market authorization of designated COVID-19 drugs. The new amendments extend these flexibilities to other public health emergency drugs added to the “list of conditions” incorporated into the FDR by reference. The Minister can add conditions to this list if they pose a significant risk to public health of Canadians. These flexibilities include streamlined licensing and authorization processes for emergency drugs, pre-positioning of drugs to address emerging public health risks, and rolling review submissions that enable faster regulatory approval. It is important to note that these flexibilities do not apply to generic drugs or biosimilars.
  • Strengthened drug quality standards during manufacturing: The amendments reinforce that drug quality must be maintained throughout fabrication, packaging/labelling, testing, storage, and transportation. These requirements apply to all licensed fabricators, packagers/labellers, testers, and wholesalers, as well as Canadian importers and distributors. The amendments align with and uphold the expectations set out in current Health Canada guidelines and the current interpretation of the FDR.
  • Modernizing requirements for biologics: Previously, the FDR included product-specific requirements for biologics (products derived from living tissues or organisms) in Part C, Division 4. Due to the rigidity of these requirements, the FDR could not keep pace with advancements in science and technology that have developed over time. Recent amendments have removed the product-specific requirements and replaced them with more general requirements focused on the underlying safety objectives of the FDR. Other updates include the removal of outdated storage requirements for manufacturers, amendments to the lot release program for biologics to support a more risk-based, tiered approach, formalizing the periodic reporting of biological product reports, and updating labelling requirements for biologics to reflect current practices. Additionally, the amendments grant the Minister greater flexibility in investigating risks associated with individual lots. If a lot is under investigated by the Minister, no drugs from that lot may be sold until the Minister grants permission. Importantly, these amendments are intended to minimally impact current manufacturers of biologics and do not alter existing industry practices and guidance requirements.
  • New rules for drug submissions: The amendments clarify that the Minister may consider external information when reviewing new drug submissions. While this aligns with current practices, it was not previously reflected in the FDR.  Additionally, in certain cases, clinical data submitted by manufacturers must be broken down by population subgroups. Notably, this is only required when the information has already submitted in a disaggregated form to the U.S. Food and Drug Administration or the European Medicines Agency. This step aims to address health disparities affecting underrepresented minority groups and better aligns Canadian regulations with those of the U.S. Food and Drug Administration and European Medicines Agency.
  • Updating the rules regarding the use of manufacturer standards: Manufacturers using a manufacturer’s standard for a new drug (i.e., a drug regulated under Part C, Division 8 of the FDR) are permitted to use different limits for purity and potency than those listed under Schedule B, provided they are deemed acceptable by the Minister. Additionally, most drugs (except for radiopharaceuticals) are no longer required to include the standard used on the package label.

Related guidance documents and notices

In relation to these changes, Health Canada has published the following guidance documents and notices:

Coming into force: Key dates

While most changes took effect on November 29, 2024, the following amendments have staggered implementation timelines:

  1. Modernizing requirements for biologics (July 1, 2025);
  2. T&Cs for Class II, III, and IV medical devices (January 1, 2026);
  3. T&Cs for all drugs (April 1, 2027); and
  4. Risk management plans (April 1, 2027).

These changes represent a significant step forward in making Canada’s regulatory framework more agile, transparent, and responsive to evolving public health needs. If you have any questions on how these amendments may impact your organization, please contact any member of the Miller Thomson LLP Marketing, Advertising and Product Compliance team.