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Introduction to the Current System
This content was archived on June 24, 2013.
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The current system of drug regulation in Canada focuses on pre-market activities and is point-in-time, not continuous. That is, the federal role only intersects with drugs at defined points in time, such as licensing or withdrawal. A manufacturer must submit a Clinical Trial Application (CTA) for authorization to conduct a clinical trial in Canada, and submit a New Drug Submission (NDS) to Health Canada to establish that a drug is safe, efficacious, and of high quality. Manufacturers must also meet requirements for the licensing of manufacturing sites and for good manufacturing practices, while Health Canada has corresponding powers of inspection.
A manufacturer selects promising molecules and moves them through drug development and clinical trial. When ready, the manufacturer files an NDS with Health Canada, which reviews the submission for its compliance with the Food and Drugs Act and Regulations. If the information complies under the proposed conditions of use (i.e., the indication, the dosage, and the population who may use it), Health Canada issues a Notice of Compliance (NOC). Along with issuing the NOC, Health Canada also authorizes labelling for the drug. The labelling includes a product monograph that summarizes the scientific and medical information about a drug.
Once the manufacturer has received an NOC, it can market the drug in Canada for specific use. The manufacturer may also apply for listing on drug formularies, which means that the drug will be covered for reimbursement, either in full or in part, by the healthcare plan that manages that formulary.
Manufacturers must satisfy the following obligations once they begin to market:
- Inform Health Canada of any reported serious adverse drug reactions;
- Adhere to the advertising restrictions in the Act and Regulations;
- Maintain the quality of their drug to the appropriate standards; and
- Apply for further authorization from Health Canada for significant changes to their product.
The Regulations provide Health Canada with tools for enforcement and compliance, including inspecting manufacturing compliance (discussion paper, Suspension of or Refusal to Issue Establishment Licences as a Means for Correcting Non-compliance) and removing a drug from the market for reasons of safety.
Contact information for the Progressive Licensing Project.
