They say you have to swallow some bitter pills in life, and getting a new drug legally authorized can feel like one of them. For this, Health Canada drug approval is the federal gateway that every medication must pass through before it can be prescribed, dispensed, or covered by a public drug plan.
How does the Health Canada drug approval process work?
Within Health Canada, the Health Products and Food Branch (HPFB), through the Therapeutic Products Directorate (TPD), reviews and approves drugs for sale. Before a drug can legally be sold or marketed in Canada, it must:
- comply with the Food and Drugs Act (FDA), and
- receive:
- a Notice of Compliance (NOC), and
- a Drug Identification Number (DIN)
Drug approval, from lab to label
Developing and approving a new drug takes about 12 years on average, and the process moves through six stages:
- Preclinical testing: researchers test new compounds in tissue cultures and small animals; if results are promising and non-toxic, they apply for permission to start human trials
- Phase 1 trials: small doses go to healthy volunteers to establish safe dose ranges and identify early side effects
- Phase 2 trials: the drug goes to the target patient group over a longer period to test whether it works and refine dosing
- Phase 3 trials: a broader and more realistic patient population takes the drug, confirming Phase 2 findings at scale
- New Drug Submission (NDS): if all three phases show benefits outweigh risks, the drug sponsor files an NDS with HPFB, including all study data, manufacturing details, and proposed labelling
- Review and decision: Health Canada’s HPFB scientists evaluate the full NDS; if approved, the drug receives its NOC and DIN
Duration of Health Canada’s review
Standard reviews target 300 days. Priority reviews, for serious or life-threatening conditions with few existing therapies, target 180 days. A Notice of Compliance with Conditions (NOC/c) targets 200 days and is used when a drug shows strong promise, but confirmatory studies are still underway.
Health Canada used this pathway to approve Albrioza, also known as AMX0035, for amyotrophic lateral sclerosis (ALS). Canada became the first country in the world to authorize it, ahead of the United States.
Once on the market, Health Canada will:
- monitor adverse reactions,
- conduct market surveillance, and
- revoke an approval at any time, if warranted
Here’s a video that shows the different regulatory pathways used for drug development and approval by Health Canada:
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How do you check if a drug is approved in Canada?
To check if a drug is approved in the country, Health Canada’s drug approval database can be accessed in their website, free of charge. Their main tools are the following:
- Drug Product Database (DPD): a searchable record of all drugs in Canada, including those currently marketed, cancelled, or dormant
- NOC database: lists every drug that has received its NOC; this list is updated weekly
- Submissions Under Review list: a monthly snapshot of what is currently in Health Canada’s evaluation pipeline
- Summary Basis of Decision (SBD) documents: detailed public explanations of the scientific rationale behind specific approval decisions
- Regulatory Decision Summaries (RDS): shorter, accessible public records of what was decided and why
When the drug is not yet approved
Physicians can turn to the Special Access Programme (SAP) if a certain drug is not yet approved in Canada. The SAP allows health care providers to request unapproved drugs for patients with serious or life-threatening conditions, where conventional treatments have failed or are unavailable. In addition, the manufacturer must also agree to supply the product.
Is Health Canada stricter than the FDA?
Not exactly; but Canadians do consistently wait longer for new medicines under Health Canada’s drug approval process, and the reasons involve more than one party.
The numbers
In a 2026 Fraser Institute study, it tracked 194 drugs that were approved in both Canada and the United States between 2019 and 2025. It found that:
- the US Food and Drug Administration (FDA) granted approval an average of 636 days earlier than Health Canada for standard-review drugs
- the European Medicines Agency (EMA) approved those same drugs an average of 459 days earlier
- 145 drugs approved by the FDA and EMA during that period were never approved in Canada
Much of the gap comes from submission timing, and not just with the speed of the review. Many pharmaceutical companies file in the United States and Europe up to a year before they submit in Canada. Once Health Canada receives a file, it actually processes it faster than the EMA by about 42 days.
The access gap that matters more
The bigger problem for most patients arrives after Health Canada grants its NOC.
Liam MacDonald, director for policy and government relations at the Canadian Chamber of Commerce, said that “there can be no economic security without health security,” as his organization urged governments to fix a system where Canadians on public plans wait an average of 52 months from a drug’s first global launch before they can access it. That is the worst record in the G7 and well above the OECD average of 45 months.
To address this, Health Canada introduced a Ministerial Reliance Order in July 2026, allowing it to formally rely on approvals from trusted foreign regulators for certain drugs, such as the FDA and EMA.
Watch this video to see more of the regulatory compliance updates for the FDA and Health Canada:
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Has Canada approved a generic version of Ozempic?
An example of how Health Canada’s drug approval process is how it approved the generic version of Ozempic. On April 28, 2026, Health Canada authorized the first generic semaglutide injection, making Canada the first G7 country to approve a generic version of Ozempic.
Canadian manufacturer Apotex received the second approval three days later, on May 1, 2026, for its Apo-Semaglutide Injection. Further approvals followed:
- Aspen-Semaglutide (Aspen Pharmacare Canada), approved July 21, 2026, including 2 mg and 4 mg pen formats
- Sandoz Semaglutide (Sandoz Canada), approved September 18, 2026, covering 0.25 mg, 0.5 mg, and 1 mg doses
While Ozempic is the best-selling drug in Canada, many Canadians without drug coverage have been paying hundreds of dollars a month for it.
A generic equivalent of Wegovy, Novo Nordisk’s semaglutide product for chronic weight management, was also authorized. Health Canada approved Sevmia on June 29, 2026, making it the first generic version of that product in Canada.
One effect of faster drug approvals is that it is now reshaping pharmaceutical competition and intellectual property strategy, which could hopefully help Canadians get more access to cheaper, yet reliable, medicines.
Health Canada drug approval: the wait is not over yet
Getting past Health Canada’s review is only the start of the journey for most medicines. So far, legal reforms show real momentum toward faster, more internationally aligned approvals. But for patients still counting months before their province covers a drug they need, the wait remains a bitter pill. While the system is working on it, it’s just not always as quickly as Canadians need.
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