Should Canada Accept Foreign Drug Approvals to Speed Up Access to Medications?

Official title: Canada Gazette, Part I, Volume 159, Number 51: Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs

Open Regulations & Permits Health & Safety
Health Canada wants to speed up drug approvals by trusting decisions from foreign regulators like the FDA or European agencies. Right now, every new medication needs a full Canadian review—even if it's already approved elsewhere. This proposal would let Health Canada skip parts of that review for certain drugs, potentially getting medications to patients faster.

Why This Matters

Waiting for a medication that's already available in the US or Europe? This could change that. Canada's small market means drug companies sometimes delay launching here. Faster approvals could mean earlier access to new treatments—especially for kids, pets, and rare conditions where options are limited.

What Could Change

Health Canada could accept drug approvals from trusted foreign regulators without repeating the full review. A new list would specify which drug categories and which foreign agencies qualify. Pediatric medications, companion animal drugs, and treatments for food-producing animals are early candidates. Canadian-specific elements like labelling would still be reviewed here.

Key Issues

  • Should Health Canada rely on foreign drug approvals to speed up access to medications in Canada?
  • Which drug categories and foreign regulatory agencies should be trusted for this streamlined process?
  • How can Canada maintain drug safety standards while accepting foreign decisions?

How to Participate

  1. Review the proposed Order in the Canada Gazette to understand the regulatory changes being proposed.
  2. Submit your comments by email to lrm.consultations-mlr@hc-sc.gc.ca within 70 days of publication.

Submit Your Input

Draft Email
Questions Being Asked (4)
  1. Do you support allowing Health Canada to rely on foreign regulatory decisions for certain drug approvals?
  2. Which drug categories should be prioritized for this streamlined approach?
  3. What safeguards should be in place to ensure drug safety when relying on foreign decisions?
  4. Are there specific foreign regulatory authorities you believe should or should not be included?

Key Documents