Changes to Canada’s Food and Drug Regulations and Medical Devices Regulations

The Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing) (the Regulations) introduce changes to the Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR) intended to provide Health Canada with additional flexibility in its approach to regulatory approvals. The Regulations are coming into force in a staggered manner to account for changes that require time to operationalize.

What you need to know

• The Regulations give Health Canada greater flexibility and additional tools to grant earlier market access for drugs and medical devices. This is through, for example, expanding Health Canada’s authority to impose terms and conditions (T&Cs) on regulatory approvals and expanding the scope of public health emergency drugs, including the option for rolling reviews of submissions.
• The Regulations also modernize regulatory processes to reflect current practices and Health Canada guidance, such as by replacing out-of-date regulations for biologics with current practice and mitigating risks through imposing T&Cs.
• Manufacturers and importers may need to implement processes to meet new regulatory obligations. New requirements to provide Health Canada with disaggregated clinical trial data and to develop risk management plans will impact manufacturers’ and importers’ regulatory workflows.

What are the Regulations?

The Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing) (the Regulations) were published in Canada Gazette, Part II on November 29, 2024. This means that the Regulations are now law; however, they are coming into force on a staggered basis.

The Regulations introduce changes to the Food and Drug Regulations (FDR) and Medical Devices Regulations (MDR) as part of Health Canada’s ongoing efforts to improve and modernize the framework overseeing drugs and medical devices.

The Regulations contain a robust set of changes that aim to update the regulatory framework to align with current policies and make improvements related to the safety and quality of drugs and medical devices in Canada.

While the Regulations include multiple changes, they can be summarized under a number of broad groups, as set out below.

Expanding the scope for Health Canada to impose terms and conditions for drugs and medical devices

The Regulations have broadened the authority of Health Canada to impose T&Cs on the market authorization of a drug or medical device. For example, a drug manufacturer may be required to undertake further studies to confirm effectiveness and/or undertake safety monitoring activities once a drug is marketed. For medical devices, Health Canada can now impose T&Cs on authorizations for class II, III, and IV medical devices (previously, they could only impose conditions related to their testing).

When considering whether to impose T&Cs, Health Canada will take into account the objective of managing uncertainties, whether T&Cs are technically feasible, and whether the objectives could be achieved through other existing requirements under the Act or its regulations.

Formalizing requirements for risk management plans

Risk management plans (RMPs) summarize the risks and uncertainties related to a drug, and the safety measures that a manufacturer intends to implement to manage those risks.

Health Canada’s prior practice has been to request, through guidance and policy, that manufacturers provide RMPs for certain drugs. The Regulations have now largely formalized previous guidance into law. This includes requirements for RMPs to contain sufficient information to enable Health Canada to identify and characterize risks associated with the drugs, and to conclude whether the plan, if implemented, would prevent/reduce those risks or address uncertainties associated with the drug. Many drug regulators, including in the U.S. and EU, already impose similar requirements.

The Regulations also dictate when an RMP (or an update) must be included in a new drug submission (NDS) or a supplement to new drug submission (SNDS). This includes where there is a significant degree of uncertainty respecting the risks associated with a drug, or where a drug may present a serious risk of injury to human health that warrants measures being taken to reduce the probability or severity of such an injury. Health Canada has recently issued guidance on submitting RMPs, which will come into effect on July 1, 2025¹.

Introducing flexibility in public health emergencies

Provisions regarding establishment licensing and pre-positioning for COVID-19 drugs in the FDR have been expanded to apply to any public health emergency in relation to drugs whose indications are on a specified list² (the List).

The Regulations expand the flexibilities, previously applied to designated COVID-19 drugs only, to any public health emergency drug. This includes the option of rolling review for regulatory submissions, where a manufacturer would provide some but not all the required information at the time of filing a submission, with safety and efficacy data being submitted as the data become available. To take advantage of these flexibilities, the purpose and conditions of use specified in the submission must relate only to a condition described on the List. These options are not available to an NDS or SNDS for a generic or subsequent entry drug.

All public health emergency drugs may now be pre-positioned in Canada (i.e., imported into Canadian storage facilities before receiving market authorization) if the drug is the subject of an NDS, SNDS, or an application made to a foreign regulator and the drug is imported by a drug establishment licence (DEL) holder.

Clarifying expectations for drug manufacturing and labelling

The Regulations clarify that a drug must be fabricated, packaged/labelled, tested or stored in a manner that assures drug quality. Where references are made to drug “storage”, the Regulations clarify that this includes storage during its transportation.

Previously, while the FDR set out requirements for quality control responsibilities with respect to methods and procedures, there was no clear requirement that storage activities must be conducted to maintain and assure the quality of the drug.

Modernizing requirements for biologics

Many of the previous regulations related to biologics did not reflect the current state of science and technology. The Regulations have removed many of the outdated regulations for biologics, including product-specific regulations, and replaced them with those that reflect current guidance and practice. This includes replacing prescriptive requirements for biological starting materials and auxiliary materials used in the manufacture of biologics with more flexible, outcome-based regulations.

Provisions regarding the lot release program have been amended to align more closely with previous guidance, to better support a risk-based, tiered approach. This includes enabling Health Canada to ask for information, samples, or other materials as required.

The Regulations have also updated some labelling requirements for biologics, which reflect current practices and are not expected to impact approved labels. This includes the requirement for the label to indicate whether any of the drug’s medicinal ingredients are derived from a human source or animal source, including species of origin. Some flexibility has also been introduced for biologic labelling: for example, the expiration date on a label can be omitted when biologics are sold between different levels of government for use in emergency situations, if the date is communicated by alternative means.

Formalizing the use of outside information

Before these Regulations, the FDR did not clearly indicate that information other than that filed with Health Canada could be considered when Health Canada examines the authorization of a new drug. In line with current practice, the Regulations clarify that Health Canada can examine information or material (i) provided by any person under the Act; (ii) obtained from sites at which the new drug or any active ingredient of the new drug is fabricated, packaged/labelled, or tested; and (iii) obtained from a foreign regulatory authority.

Requirement to provide disaggregated clinical trial data

The Regulations introduce the requirement for manufacturers to submit disaggregated clinical trial data where such data has already been submitted to the USFDA or the EMA.

Before these Regulations, there was no requirement for disaggregated data to support new drug submissions. Given that different effectiveness and safety profiles can result from the use of a drug between diverse subgroups (e.g., gender, ethnic minorities, age groups), Health Canada has expressed that disaggregated data is important to best evaluate a new drug. Health Canada may move towards imposing additional disaggregated data requirements to better understand how drugs work in diverse populations.

Implementation of the Regulations

The following Regulations came into force upon publication in the Canada Gazette, Part II on November 29, 2024:

• Public health emergency drugs (including T&Cs, rolling reviews and pre-positioning);
• Assuring drug quality during manufacturing;
• Information considered to support the examination of drug submissions; and
• Disaggregated clinical trial data for new drug submissions and supplements to new drug submissions.

The Regulations related to the following require additional time to operationalize and will be delayed coming into force:

• Modernizing requirements for biologics – on July 1, 2025;
• T&Cs for Class II, III and IV medical devices – on January 1, 2026;
• T&Cs for all drugs – on April 1, 2027; and
• Risk management plans – on April 1, 2027.