Canada has made wide-ranging amendments to the Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR). The amendments are intended to deliver on Health Canada’s modernization commitments, codify long-standing policies and practices, and implement regulatory agilities piloted during the COVID-19 pandemic. Some of the amendments are already in force, while others come into force later in 2025, 2026, and 2027.
Background
In December 2022, Health Canada launched a consultation on draft amendments to the FDR and MDR (see our report here). The consultation ran until April 2023. Health Canada received approximately 2,800 comments, including about 60 from pharmaceutical and medical device companies, industry associations, Health Technology Assessment organizations, associations representing health care professionals, and academics.
Key changes to the FDR and MDR
Terms and Conditions. Under the amendments, the Minister of Health (Minister) can impose terms and conditions (T&Cs) on a drug or medical device after considering certain factors, including objectives such as managing the drug’s risks and uncertainties and optimizing its benefits. The Minister must also consider “whether there are less burdensome ways for those objectives to be met”. T&Cs can be imposed, amended, or removed at any time. The T&C-related amendments come into force in three waves:
- Since December 18, 2024, under certain FDR amendments, the Minister has been able to impose T&Cs on public health emergency drugs (see definition below).
- On January 1, 2026, the MDR amendments and new guidance come into force. The amendments broaden the Minister’s use of T&Cs beyond testing on Class II, III, and IV medical devices.
- On April 1, 2027, the other FDR amendments come into force. Notably, these amendments will replace Health Canada’s Notice of Compliance with Conditions policy, which generally allows for conditional approval of promising new drugs for serious, unmet medical needs.
Risk Management Plan. A Risk Management Plan (RMP) summarizes the pharmacovigilance activities and other measures a manufacturer will use to manage a drug’s identified risks and uncertainties. The FDR amendments make changes that reflect Health Canada’s current RMP guidance. For instance, a new drug submission must include an RMP if the drug has a significant degree of uncertainty of risk, or presents a serious risk to human health that warrants measures other than labelling. The RMP amendments will come into force on April 1, 2027 and have transitional provisions for existing RMPs filed with Health Canada (see here).
Biologics. The FDR amendments remove product-specific regulations for biologic drugs and replace them with more general requirements meant to assure product safety. The amendments also address lot release, quality reporting, and labelling of biologic drugs. These amendments will come into force on July 1, 2025.
Rolling reviews extended to other emergency drugs. The FDR amendments extend the flexibilities introduced for COVID-19 drugs to other new drugs that address a public health emergency. Such drugs must relate to a condition on the List of Conditions that Threaten Public Health. Currently, the list only includes COVID-19, but the Minister can add a new condition if it presents “a significant risk to public health” requiring “immediate action”. Under the amendments, approval of public health emergency drugs is facilitated through, among other measures, the option of a “rolling review”. A rolling review allows a manufacturer to submit certain information on a rolling basis while the submission is being reviewed, potentially making the drug available sooner. These amendments have been in force since December 18, 2024.
Other FDR amendments: Other FDR amendments have been in force since December 18, 2024:
- Outside information. The amendments clarify the Minister’s authority – while Health Canada is reviewing a drug submission – to examine information and material: provided by “any person under the Act”, obtained from a drug fabrication or packaging/labelling site, or obtained from a foreign regulatory authority.
- Breakdowns of clinical trial data. The amendments require that new drug submissions include disaggregated clinical trial data where such data has already been submitted to the U.S. Food and Drug Administration or the European Medicines Agency. This data is meant to allow Health Canada to better assess a drug’s safety and effectiveness in different subgroups (e.g., sex, race, ethnicity).
- Quality assurance. The amendments clarify expectations that drugs are to be fabricated, packaged/labelled, tested, and stored, including during transportation, in a manner that assures their quality.
- Drug standards. Where a manufacturer uses its own standard for a new drug and that standard is acceptable to the Minister, the amendments exempt it from having to meet the most stringent limits for purity and potency set out in Schedule B of the Food and Drugs Act. In addition, drug package labels no longer have to indicate the standard used. Notably, these two changes do not apply to radiopharmaceutical drugs.
Links:
- The FDR and MDR amendments were published in Canada Gazette, Part II, Vol. 158 on December 18, 2024 (link)
- Notices and guidance documents related to the amendments were published by Health Canada on December 18, 2024: