Drug Quality Surveillance Program

Learn about the Drug Quality Surveillance Program, which monitors the quality of pharmaceutical products in Canada.

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What we do

Health Canada's mandate is to help maintain the health and safety of people in Canada.

One of the programs that helps us meet this mandate is the Drug Quality Surveillance Program. Our program has 2 goals, to:

  • test the quality of drug products in Canada
  • verify the analytical methods used by the company to assess quality
    • companies are those that hold a drug establishment licence (DEL)

We collect and test pharmaceutical (drug) products that are authorized for sale in Canada. These market-authorized products are identified by a drug identification number (DIN). They include active pharmaceutical ingredients (API) and finished products for human and veterinary uses.

About the laboratory program

Our surveillance program falls under the Health Products Laboratory Program. This program:

  • requests market-authorized products from DEL holders
  • monitors products to make sure they comply with the Food and Drugs Act and Food and Drug Regulations

Market surveillance is also an important part of the mutual recognition agreements that Health Canada has with international regulatory authorities.

Learn more:

ROEB laboratories

The Health Products Laboratory Program comprises the 3 laboratories operated by the Regulatory Operations and Enforcement Branch (ROEB):

  • 1 microbiology laboratory (Longueuil, Quebec)
  • 2 chemistry laboratories (Longueuil, Quebec, and Toronto, Ontario)

The laboratories test active pharmaceutical ingredients and finished products. When we find a deficiency with a document or product, we work closely with ROEB inspectors to support compliance and enforcement actions.

Learn more:

Contact us

For general enquiries, email us at dqsp-psqm@hc-sc.gc.ca.

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