Therapeutic Product Recall and Licence Reforms

Summary#

These are proposed changes to the Food and Drug Regulations and the Medical Devices Regulations from Health Canada that would tighten and clarify how drug and device recalls are reported and tracked. The changes would also modernize establishment licences and let some complex products skip routine finished-product testing in certain cases. The proposal was published on April 15, 2023 with a 75‑day comment period (deadline: June 29, 2023).

What it does#

• Makes written notifications to Health Canada mandatory and faster for many recalls:
  • Firms that voluntarily decide to recall a drug or a device must tell the Minister within 24 hours and provide more detailed information soon after (including a fuller report within 72 hours and a final report within 30 days).
• Creates clear rules for recalls ordered by the Minister:
  • Anyone ordered to carry out a recall must provide specified information and timing as directed by the Minister, and must submit communications about the recall before it starts.
• Changes how low‑risk device recalls are handled:
  • Manufacturers and importers would only have to report device recalls that are likely to cause injury (so many low‑risk “Type III” recalls would no longer be reported up front), but all recalls must be recorded and the records kept.
• Updates establishment licence rules:
  • Modernizes information required on medical device establishment licences (MDELs) and allows the Minister to add or change licence “terms and conditions” to target specific risks without shutting down all activities.
• Updates how foreign inspection outcomes are used:
  • Replaces a fixed table of foreign regulators in the Food and Drug Regulations with an ambulatory list (kept on the government website) so mutual recognition agreements can be reflected more quickly.
• Lets some hard‑to‑test products skip finished product testing in limited cases:
  • Conditional exemptions for certain radiopharmaceuticals, gene therapies, and cell therapies when testing would be impractical, provided firms keep evidence that testing was done earlier and storage/transport didn’t compromise quality.
• Timing:
  • Most changes would come into force six months after registration, except the designated regulatory authorities list and the finished‑product testing exemptions, which would be effective immediately on registration.

Who's affected#

• Manufacturers, importers, distributors, packagers and labellers of drugs and medical devices.
• Holders and applicants for drug establishment licences (DELs) and medical device establishment licences (MDELs).
• Health care providers and specialized clinics that handle short‑lived radiopharmaceuticals or one‑patient cell and gene therapies.
• Patients and the public, especially users of medically necessary niche products and vulnerable groups who rely on steady supplies.
• Health Canada (as regulator) and its inspection and compliance programs.

If the source is unclear about who is affected in a specific case (for example, exactly which products will qualify for testing exemptions), the regulations say Health Canada will set and explain the conditions.

Why it matters#

• Faster and clearer reporting gives regulators earlier, better information on safety problems. That helps protect patients by improving oversight of recalls and enabling quicker government action when needed.
• Requiring record‑keeping for all recalls preserves oversight of low‑risk fixes that won’t be reported up front. That reduces unnecessary public alarm while keeping the ability to check whether recalls were done properly.
• Allowing conditional exemptions from finished product testing for some radiopharmaceuticals and advanced therapies can reduce delays and costs that currently slow patient access to these treatments.
• Modernizing licence rules and letting the Minister add targeted licence conditions gives Health Canada more flexible tools to fix specific problems without shutting down whole businesses — which can help avoid device shortages.
• The department estimates a net monetized benefit of $39,536,684 (present value over 10 years), with annualized benefits of $5,817,052; industry costs are estimated to be modest. These are the government’s estimates and reflect assumptions described in the proposal.