About Generic Drugs

According to the CGPA, nearly 75% of all prescriptions filled by pharmacies in Canada are filled with generic drugs.1

With many popular drugs having come off patent, use of generics is expected to grow over the coming years. In addition, generic drug options allow greater access to quality healthcare for all Canadians.

A generic drug is a medication created to be equivalent to an existing approved brand-name drug in dosage form, safety, strength, route of administration, quality and performance characteristics. Health Canada is responsible for evaluating generic drugs for their safety, effectiveness and quality. The process for evaluating drug products is constantly being improved and updated to keep up with international standards of regulatory approval. Before drug products are authorized for sale in Canada, Health Canada reviews them to assess their safety, efficacy and quality.

Prior to being given market authorization, a manufacturer must present substantive scientific evidence of a product’s safety, efficacy and quality as required by the Food and Drugs Act and Regulations.

When a prescription or Over-the-counter product is offered for sale in Canada to treat or prevent diseases or symptoms, it is regulated as a drug under the Food and Drugs Act.

During the application process, each generic drug must, among other things, meet the same Health Canada quality, safety and effectiveness standards as the brand-name drug by demonstrating that:

  • The active ingredient is the same as that of the brand-name drug/innovator drug
  • The generic medicine is the same contains the same amount of medical ingredient
  • The medicine is the same type of product (such as oral dosage form or an injectable)
  • The medicine has the same route of administration (such as oral or topical)
  • It has the same therapeutic classification as the innovator drug
  • The inactive ingredients of the medicine are acceptable
  • It complies with Good Manufacturing Practices (GMP) to ensure that the drug meets the appropriate quality standards for their intended use prior to being sold
  • The container in which the medicine will be shipped and sold is appropriate

To learn even more about generic drugs, visit Health Canada.

Reference: 1. IQVIA, 12 months ending December 2022