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Drug Approval Process

Before a drug can be administered in Canada, it must go through a rigorous approval process with Health Canada. It is important to note that once the drug has been approved, it can take years before patients have access to it. To improve patient outcomes, Myeloma Canada works diligently with patients, the medical community and our partners to help accelerate access to new therapies.

Step one: Notice of Compliance

If the drug company’s submission is approved, Health Canada will issue a Notice of Compliance (NOC) and give the drug a Drug Identification Number (DIN). This means the company is now allowed to market the new drug in Canada. In some cases, Health Canada may award a Notice of Compliance with Conditions (NOC/c). A drug given NOC/c status is assigned a DIN, and the manufacturer must agree to special conditions before it can be made available to patients. 

Step two: Pan-Canadian Oncology Drug Review

Once a new cancer drug is approved for use in Canada, the manufacturer must make a submission to the pan-Canadian Oncology Drug Review (pCODR) for evaluation. The pan-Canadian Oncology Drug Review was set up by the provincial and territorial Ministries of Health to make recommendations as to whether new drugs should be covered under provincial formularies – the list of medications they will pay for. The hope is that it will streamline the drug review process and encourage greater consistency in cancer drug funding across the country.

Step three: Price Negotiations

The Pan-Canadian Pharmaceutical Alliance (PCPA) conducts joint price negotiations with the drug manufacturers on behalf of the federal, provincial, and territorial governments. All new, publicly funded drugs undergo this process.

Despite the national review processes that are in place, most provincially funded drug plans continue to decide which medications they will list on their formulary and pay for. As a result, coverage of new treatments often varies across the country. In some cases, even when a new drug is added to the formulary, the decision to pay for it is made on a case-by-case basis. This special authorization process requires physicians to write a letter to the drug plan, explaining why a particular medication is required. For more details, read our section on drug coverage.

For more information on the drug approval process in Canada, download our Multiple Myeloma Patient Handbook.