Without much fanfare, Health Canada announced in the Canada Gazette Part 1 on Dec. 22, 2025 that it was beginning a 70-day consultation period on using the decisions of foreign drug regulators such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to approve new drugs in Canada.
If the proposal is approved, Health Canada will evaluate reports from the other regulators, and provided those reports are satisfactory and that the drugs met certain conditions (for example, the drug being considered by Health Canada has the same strength, dosage form, route of administration, medicinal ingredient and indications as the foreign drug), the new drug will be approved.
This announcement appears to be a continuation of the federal government’s Red Tape Review launched in July 2025. According to a report on this initiative, Health Canada’s rationale for this change is that “industry stakeholders have indicated that they face undue burden due to overlapping or unclear regulatory requirements, complex regulatory approvals, and onerous reporting and information demands” and have “raised concerns about the time it takes to get products to market.”
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Health Canada states that “enhanced international regulatory alignment reduces burden for industry and can support increased health product submissions to Canada” and increase the number of new drugs available to Canadians.
These views reflected in the Red Tape Review align with those of the pharmaceutical industry. In its 2025 pre-budget submission to the federal government, Innovative Medicines Canada (IMC), the main pharma industry lobby group, said that “reliance on trusted foreign regulatory reviews where appropriate…will streamline drug approvals and enable Health Canada to be a global regulatory leader.”
Faster drug approvals would also mean a shorter timeline to revenue generation for drug companies.
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Benefits need to be evaluated
On the surface, this sounds like a reasonable initiative; countries with strong regulatory systems can draw on each other’s strengths so that tasks are not unnecessarily duplicated. In Canada’s case, our resources and capacity are limited compared with those of other leading regulatory authorities like the FDA and the EMA.
But before Canada starts using decisions from other jurisdictions, there is a need to evaluate whether this new way of approving drugs is actually going to be beneficial.
Australia has been using such a system since 2018. One of the benefits touted by the Australian government was that new drugs would be submitted faster to the Therapeutic Goods Administration (TGA), the equivalent of Health Canada.
But comparing the gap in the timing of submissions to the FDA and the TGA since Australia began using foreign regulator decisions doesn’t provide any convincing evidence that this has actually happened.
My new study, currently under peer review, looks at the 29 drugs that have so far used the Australian system. Twenty-two of those drugs have been evaluated by one or more organizations that look at how much additional therapeutic value new drugs provide compared to existing therapies. Sixteen of the 22 offered only minor new gains and just two were a major benefit.
FDA standards and approval pathways
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The U.S. approves more new drugs than Canada does. But a recent study that compared Canada and the U.S. found that many drugs available in the U.S., but not north of the border, already had existing alternatives that are therapeutically and chemically similar. The small number of drugs that were unique to the U.S. were not very clinically important.
The FDA has increased its reliance on what are called expedited drug approval pathways in recent decades. These allow drugs onto the market with lower levels of evidence. Although they were initially designed for drugs that treat rare conditions or life-threatening illnesses that don’t have effective treatments, researchers have found that these expedited pathways are being increasingly used for drugs that may not be innovative.
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Controversial Alzheimer’s drug highlights concerns about Health Canada approval process
If Canada were already using foreign decisions, aducanumab (brand name Aduhelm) might have been put on the market in Canada as a treatment for Alzheimer’s disease. In the U.S., the FDA approved aducanumab despite a lack of evidence that it would benefit Alzheimer’s patients, and despite and the negative vote of 10 of the 11 members of the FDA’s advisory committee — the 11th member abstained — and the subsequent resignation of three of the committee members. The manufacturer eventually pulled Aduhelm from the U.S. market because almost no doctors were prescribing it.
Different regulatory cultures, different decisions
We also need to think about the consequences of the homogenization of drug approval standards. Homogenization ignores the development of different regulatory cultures in different jurisdictions that arise from networks of individuals who produce regulatory policy, determine testing standards and ultimately decide on market access for new drugs.
When presented with essentially the same evidence, the FDA and the EMA often make different decisions about oncology drugs. A 2020 study found frequent discordance between the FDA and the EMA. Another study compared the approval of 42 cancer drugs between 1995 and 2008 by the FDA and the EMA, and showed that in almost 50 per cent of cases, there was a discrepancy between EMA and FDA decisions.
So far, there is no evidence to back up the claim that using decisions made by foreign drug regulators will lead to faster access to newer and better drugs. Before Canada proceeds down this pathway, Health Canada needs to show that it will improve public health.
