How are drugs approved for use in Canada?

Health Canada is responsible for authorizing the sale and use of new drugs in Canada. It takes 2 to 4 years for Health Canada to review drug safety and efficacy information from clinical trials before deciding to approve (or reject) the use of a new medication. However, even after a drug receives marketing approval, each province must still decide whether or not to reimburse the cost of the new medication.

Health Canada’s Drug Approval Process

Pharmaceutical companies who sponsor a new drug must follow a well-defined process to qualify for drug approval.

Step 1 > The developer of the drug submits an application to Health Canada to obtain permission to conduct clinical trials in Canada.

Step 2 > If clinical trials show that the new drug’s potential therapeutic value outweighs the risks of adverse effects, the pharmaceutical company may choose to submit a New Drug Submission to the Health Products and Food Branch (HPFB) of Health Canada.

Step 3 > Health Canada performs a thorough review of clinical trial data on drug safety and efficacy that the pharmaceutical company provides in the New Drug Submission.

Step 4 > If Health Canada findings reveal that the new drug’s benefits outweigh its risks, the HPFB issues a Notice of Compliance (NOC) and a Drug Identification Number (DIN), which allows the company to market the drug in Canada.

Early access is possible!

Sometimes, patients can obtain an experimental therapy through Health Canada’s Special Access Programme (SAP) [Link to “How can you access a new treatment?”] before the drug review process ends. In this case, the cost of treatment is not reimbursed.

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