Health Canada increasing oversight of marketed drugs and medical devices

Health Canada recently proposed amendments to the Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR) to strengthen post-market oversight of drugs and medical devices. The proposed amendments are not yet law, and stakeholders can provide feedback on the proposed amendments until June 29, 2023.

What you need to know

If enacted, the proposed amendments would increase Health Canada’s post-market oversight of drugs and medical devices. The proposed amendments:

• introduce reporting obligations for both recalls initiated by the manufacturer/importer of a drug or medical device, as well as recalls ordered by Health Canada;
• provide a flexible list of designated regulatory authorities outside of Canada, which will allow holders of drug establishment licenses (DELs) to leverage the outcomes of inspections by other regulatory authorities, reducing the burden on importers and promoting access to drugs in Canada;
• exempt finished product testing for certain drugs that cannot practically or reasonably be subject to finished product testing; and
• impose terms and conditions to a Medical Device Establishment Licence to provide additional oversight of potential risks and uncertainties related to the medical device or licensed activities.

Proposed amendments to the Food and Drug Regulations

Improved recall framework

Voluntary recalls

The proposed amendments to the FDR would codify certain recall reporting requirements currently set out in Health Canada’s guidance document, the Drug and natural health products recall guide, for manufacturers and importers that decide to recall a drug in dosage form or an active ingredient, without being ordered to do so by Health Canada (i.e., a voluntary recall). For example, as per the proposed amendments, the manufacturer or the importer must initially report the recall within 24 hours of making the decision to recall. They would also need to provide information on (i) the product, (ii) quantity and distribution, (iii) details about the recall, and (iv) an assessment of the effect that the recall may have on the manufacturer’s or importer’s ability to meet demand for the drug in Canada for drugs in dosage form. Within 72 hours after making the decision to recall, additional information must be provided to Health Canada, including the recall strategy and a description of the corrective and preventive actions intended to be taken to prevent a recurrence of the issue that led to the recall.

Recalls ordered by Health Canada

The proposed amendments would also introduce a reporting framework for recalls ordered by Health Canada. In this situation, the recalling party must provide Health Canada with details on (i) the quantity of drugs being recalled and their distribution, (ii) an assessment of the risk of injury posed by the recalled drug, (iii) the recall strategy, and (iv) a description of corrective and preventive actions. Health Canada would direct the timing and format for reporting, assessed on a case-by-case basis depending on the serious or imminent risk of injury to health posed by the drug.

For both voluntary recalls and for recalls ordered by Health Canada, all customer communications would need to be provided to Health Canada for review before they are distributed. After the recall is initiated, Health Canada could request copies of any additional communications that are intended to be used or are used in relation to the recall. In addition, within 30 days after completing the recall, Health Canada would also need to be provided with the results of the recall and a description of the corrective and preventive actions that have been or will be taken to prevent a recurrence of the situation that led to the recall.

Designated regulatory authorities

In Canada, any licensable activity for a drug (i.e., fabrication, packaging/labelling, importation for sale, testing, distributing or wholesaling) must be conducted under a DEL issued by Health Canada¹. To be issued a DEL, the applicant must demonstrate compliance with good manufacturing practices (GMP). Compliance may be in part determined through an inspection and assessment of GMP evidence by Health Canada or by providing compliance certification from a regulatory partners under a Mutual Recognition Agreement (MRA) with Canada (i.e., a Designated Regulatory Authority, or DRA).

The proposed amendments would repeal the currently outdated table of DRAs² and incorporate, by reference, a flexible list of DRAs, which would include all regulatory authorities within countries that have an MRA with Canada³. The flexible list of DRAs would reflect current and any new regulatory partners that enter into an MRA with Canada, allowing DEL holders to leverage the outcomes of inspections by the applicable DRA, reducing the burden on importers and promoting access to drugs in Canada.

Finished product testing

Under the current GMP requirements set out in the FDR, finished product testing on a drug sample must be conducted, subject to certain exceptions⁴. This requirement has become increasingly impractical for novel therapeutic products (e.g., gene and cell therapies and radiopharmaceuticals) where the supply of small batch drugs or drugs with a very short shelf life (measured in hours) may be impacted by the finished product testing. These therapeutic products would be exempt from finished product testing under the proposed amendments.

Proposed amendments to the Medical Devices Regulations

Improved recall framework

The proposed amendments to the MDR would amend the definition of recall to include both recalls initiated by a manufacturer, importer or distributor of medical devices (i.e., a voluntary recall), as well as a recall ordered by Health Canada.

Voluntary recalls

As per the proposed amendments, the MDR would require that voluntary recalls (Reportable Voluntary Recall) be reported within 24 hours of making the decision to recall and provide (i) information on the medical device and manufacturer, (ii) details about the recall, and (iii) a preliminary assessment of the risk associated with the defectiveness or potential defectiveness of the medical device.

If the medical device is likely to cause injury, or could cause serious injury, to the health of a patient, user or other person (Reportable Voluntary Recall), the following additional information must be provided to Health Canada:

• distribution information,
• a copy of any communications regarding the recall,
• the recall strategy,
• a description of corrective and preventive actions, and
• the manufacturer or importer contact for the recall.

Recalls ordered by Health Canada

The proposed amendments would also introduce a reporting framework for recalls ordered by Health Canada, where the recalling party must report to Health Canada details about the (i) medical device, (ii) quantity and distribution information, (iii) recall strategy, and (iv) a description of the proposed corrective and preventive actions. Similar to the recall framework for drugs, all customer communications would need to be provided to Health Canada for review before they are distributed. After the recall is initiated, Health Canada could request copies of any additional communications that are intended to be used or are used in relation to the recall. Further, Health Canada would need to be notified within 24 hours of the beginning and completion of the recall.

For both Reportable Voluntary Recalls⁵ and for recalls ordered by Health Canada, within 30 days after completing the recall, Health Canada would also need to be provided with the results of the recall and a description of the corrective and preventive actions that have been or will be taken to prevent a recurrence of the situation that led to the recall.

New record keeping requirements⁶ would also be introduced by the proposed amendments that apply to manufacturers/importers⁷ and distributors⁸. Manufacturers would need to keep the applicable records for the projected useful life of the medical device plus two years or for as long as the medical device is being sold, whichever is longer. All other persons would need to keep records for at least the projected useful life of the medical device plus two years.

Medical Device Establishment License framework

Any person who imports into, or sells a medical device for human use in, Canada requires a Medical Device Establishment Licence (MDEL), subject to certain exceptions⁹. The proposed amendments would allow Health Canada to impose or amend terms and conditions on an MDEL at any time. Before imposing or amending terms and conditions to the MDEL, Health Canada would consider:

• whether there are uncertainties relating to the manner in which an activity is or will be conducted;
• whether the requirements under the Food and Drugs Act are sufficient to protect patients, users or other persons from risks to health or safety;
• whether compliance with the terms and conditions is feasible; and
• whether there are less burdensome ways to meet the objectives of the terms and conditions.

Situations where terms and conditions could be applied to an MDEL could, for example, include the following:

• restricting importation and distribution of medical devices in cases where an MDEL holder does not have adequate storage and handling procedures, putting the safety of a specific kind of medical device at risk;
• requiring an MDEL holder to provide Health Canada with sufficient evidence to demonstrate their ability to effectively conduct a recall where the MDEL holder’s compliance history demonstrates an inability to consistently or effectively conduct recalls; and
• requiring that an MDEL holder provide information to trace the medical device through the supply chain (e.g., shipping and receiving records, up-to-date distributor information, complaint records) if there are concerns regarding the safety and effectiveness of a specific medical device.

The imposition of terms and conditions to MDELs is intended to allow Health Canada to take targeted action to address specific areas of non-compliance related to the importation or sale of medical devices, while allowing compliant aspects of a business to continue.

What’s next?

The proposed amendments would come into force six months from the date of registration, except for amendments to the FDR relating to the DRAs and finished product testing, which would come into force immediately upon registration. Currently, there is no published timeline on when the proposed amendments to the FDR and MDR will come into force.

Comments on the proposed amendments to the FDR and MDR may be made until June 29, 2023. Stakeholders are encouraged to provide feedback for consideration by Health Canada before the final regulations are published.