How a drug gets approved in Canada, step by step
Published October 26, 2026. Explainer based on Health Canada's own fact sheet, cited below.
Quick take: a drug needs Health Canada permission to be tested, then a full review before it can be sold. The proof of that is a Notice of Compliance and a DIN.
The 5 steps
| Step | What happens |
|---|---|
| 1. Clinical trial authorization | Health Canada reviews preclinical results, production methods and investigator details before a trial starts |
| 2. New Drug Submission | The sponsor files safety, effectiveness and quality data if the trial results show benefit outweighs risk |
| 3. Review | Health Canada evaluates safety, efficacy and quality, and the proposed label. A priority track exists for serious conditions with few treatments |
| 4. NOC and DIN | If benefits outweigh risks, the drug gets a Notice of Compliance and a Drug Identification Number, which permit marketing |
| 5. Post-market checks | Adverse reaction reports, inspections, complaints and recalls are monitored |
Why this matters when you read peptide news
If a peptide has no NOC or DIN, it has not completed this path for sale as a drug in Canada. See what Health Canada says about BPC-157 and what each trial phase proves.
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Common questions
What is a Notice of Compliance?
Health Canada's authorization that allows a drug to be marketed, issued when benefits outweigh risks.
What is a DIN?
A Drug Identification Number that is issued with the Notice of Compliance.
Does Health Canada check drugs after approval?
Yes. It monitors adverse reactions, inspects sites, investigates complaints and manages recalls.
Sources
Summarised in my own words. Read the originals for the full detail.