Canada’s Proposed Drug Reliance Order:

Posted on by Julien S.

Faster Access, but Questions Remain

Health Canada has proposed a new Order on Reliance on Foreign Regulatory Decisions (the “Order“), intended to speed up Canadians’ access to new medicines. The Order would allow Health Canada to rely on decisions or review documents from trusted foreign regulators when examining certain drug submissions.

The goal is straightforward: improve efficiency and reduce delays without compromising safety.

How It Works

The Order introduces three mechanisms for using foreign regulatory work:

  • General Deeming for drugs already authorized abroad
  • A 120‑Day Filing Option for early filing in Canada
  • Joint Reviews conducted with partner regulators

In these scenarios, parts of Health Canada’s review—clinical, non‑clinical, or manufacturing—could be “deemed” complete based on foreign evaluations. Health Canada would still review Canadian‑specific elements such as labelling and branding.

The Potential Benefits

If implemented, the framework could reduce administrative burden, streamline reviews, and bring new drugs to Canadians sooner, including pediatric and other high‑need therapies. Health Canada estimates a positive net benefit over 10 years due to increased efficiency.

But There Are Concerns

While promising, the proposal raises important questions for domestic industry:

Uncertainty for Local Manufacturers

Canadian manufacturers that focus primarily on the domestic market may not have foreign approvals to rely on. As a result, they may face longer, more traditional review pathways while multinational firms benefit immediately from reliance mechanisms.

Scope of the IbR List Still Unclear

The Order relies heavily on an Incorporated‑by‑Reference List (IbR List) that will define:

  • which drug classes are eligible
  • which foreign authorities qualify

However, at this stage, the actual scope of the IbR List remains undefined. Only limited classes and regulators are expected at first, with expansion occurring over time. The lack of visibility makes it difficult for industry—especially smaller domestic players—to plan ahead.

What Comes Next

The proposal is open for public comment until February 28, 2026. After reviewing submissions, Health Canada will refine the Order and publish the final version in the Canada Gazette, Part II. Additional guidance will follow to support implementation.