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 accepting decisions from trusted 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 or skip 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 foreign regulators like the FDA, EMA, or others on an approved list. Three pathways would be created: accepting existing foreign decisions, fast-tracking submissions filed within 120 days of foreign filing, and joint reviews with partner agencies. Canadian-specific elements like labelling would still be reviewed here.

Key Issues

  • Which foreign regulatory agencies should Canada trust for drug approvals?
  • What types of drugs should be eligible for streamlined approval?
  • How can Canada maintain safety standards while speeding up reviews?
  • Should this apply to veterinary drugs and pediatric medications?

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

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Key Documents