Reliance on Foreign Drug Decisions

Summary#

This is a proposed ministerial order from Health Canada called the Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs. It would let the Minister of Health treat parts of some drug review files as already examined when certain foreign regulators have already reviewed equivalent information, with the goal of speeding access to some products in Canada. The proposal is open for public comment for 70 days after publication (December 20, 2025).

What it does#

• Lets the Minister of Health "deem" that parts of the required review of a new drug submission are complete based on a decision or documents from specified foreign regulatory authorities (FRAs). The legal power comes from the Food and Drugs Act.
• Applies only to drug classes and FRAs listed in a separate list called the List of Classes of Drugs and Foreign Regulatory Authorities for the Purposes of Reliance on Decisions or Documents (short: IbR List). That list would be updated over time.
• Provides three ways deeming could be used:
  • General Deeming — rely on an FRA decision already made for some parts of a submission (chemistry & manufacturing, non‑clinical, or clinical).
  • 120‑day Filing — allow a Canadian submission to be filed within 120 days of the foreign filing so Health Canada can start work while the FRA reviews; deeming would follow if the foreign authority then authorizes the product.
  • Joint Reviews — where Health Canada and one or more FRAs jointly review a product, parts of those joint review conclusions could be used to deem some examination steps complete.
• Requires manufacturers to still file a full submission in Canada and to show any differences between the Canadian product and the foreign product would not harm safety or effectiveness. Health Canada would always review Canada‑specific items such as labelling, brand name checks, withdrawal periods for food‑producing animals, and other national requirements.
• Requires manufacturers to describe any post‑market measures imposed by the FRA (like confirmatory trials) and to notify Health Canada when those measures are fulfilled. Intellectual property protections and other Canadian regulatory safeguards would remain in place.
• The order is proposed (not yet in force). If made, it would come into force on publication in Canada Gazette, Part II; some added provisions (sections 10 and 11) would come into force on April 1, 2027.

Who's affected#

• Pharmaceutical and veterinary drug manufacturers, especially companies that already have approvals from foreign regulators that might be put on the IbR List.
• Multinational companies that market the same drug in several countries may gain the most from faster entry into Canada.
• Generic and biosimilar makers could be affected depending on whether comparative submission types are included in the scope later.
• Health Canada itself (its reviewers and resource planning) and related federal program areas that deal with post‑market oversight.
• Health Technology Assessment bodies and the pan‑Canadian Pharmaceutical Alliance (pCPA), because faster or different types of approvals could change timing for reimbursement reviews and pricing negotiations.
• Patients and clinicians, particularly those waiting for products that are not currently available in Canada (examples in the proposal include pediatric formulations and some veterinary drugs).
• Smaller Canadian manufacturers that mainly sell only in Canada may not benefit and could face increased competition over time.
• It is unclear, from this notice, exactly which drug classes and which foreign regulators will be on the IbR List at the start — that detail will determine who notices the change most.

Why it matters#

• It aims to shorten the time some drugs take to reach Canadian patients by reducing duplicate review work when trusted foreign regulators have already done comparable assessments.
• Health Canada estimates measurable savings and benefits: total minimum costs of $1.33 million (PV) and total minimum benefits of $3.69 million (PV), giving a projected net benefit of $2.36 million (PV) over 10 years (annualized benefits $525,825; annualized net $335,721). The department used a working estimate of at least 19 submissions per year using the deeming approach in its analysis.
• In practice this could mean earlier access for patients (for example, child‑friendly medicines not currently authorized in Canada) and allow Health Canada to focus its review resources on more complex or higher‑risk files.
• The approach keeps Health Canada responsible for Canada‑specific checks and for any parts where differences could affect safety; if differences raise concerns, a full Canadian review would still be required.
• The real effects depend on which drug classes and which foreign regulators are added to the IbR List, how often manufacturers use the options, and how Health Canada implements the process — those details are still to be decided and will be subject to consultation.