How are drugs approved?

Health Canada reviews

Health Canada reviews every new drug product before it can be sold in Canada. The process can take between one and two years. There are three main steps :

  1. The drug manufacturer must submit scientific proof to Health Canada that the product
    • is safe
    • does what it is supposed to do, and
    • follows all Canadian quality standards.
  2. Health Canada will review and approve the drug if it meets these conditions.  More complex products require a longer review period.
  3. Health Canada will issue a Notice of Compliance (NOC) and a Drug Identification Number (DIN) for all approved products.

    Learn more about the approval process from the Health Canada website.

    Important Note: Health Canada’s approval of a drug for sale in Canada does not automatically mean that Ontario’s drug programs will fund the drug.

    The next step for approval:

For More Information

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