Supporting greater availability of lower-cost generic drugs for Canadians

Thursday, April 4, 2019 Drug News
Email Print This Page Comment bookmark
Font : A-A+

Proposed changes offer Canadian patients more choices

OTTAWA, April 4, 2019 /CNW/ - Canadians want improved access

to a wider range of safe and affordable medications. Health Canada is exploring all options for reducing the cost of drugs for Canadians. Generic drugs can offer the same benefits as brand name drugs at a lower cost,
while maintaining safety. Drugs can be authorized as generics if they have the same effects as their brand name counterparts, as well as the equivalent dosage and strength. Approving more generic versions of brand name drugs is one way to help reduce costs for the healthcare system.

To help accomplish this goal, Health Canada is proposing regulatory amendments to the Food and Drug Regulations that would give generic drug manufacturers greater flexibility in how they develop drugs, while maintaining the safety, quality and efficacy of these drugs.

The proposed regulations would allow for the authorization of generic drugs that have the same active ingredients as brand name drugs but in different forms (e.g., different salts), provided they achieve the same dose and effect and maintain safety. This change would result in the greater availability of lower-cost generic drugs for Canadians.

Drug companies seeking authorization for a drug as a generic would still have to demonstrate that the ingredients used in their medications are equivalent to the brand name reference drug and that they do not affect the safety, quality or efficacy of the medication.

The proposed amendments would also clarify labelling requirements for medicinal ingredients in certain drugs. This clarification would help provide health professionals and Canadians with clearer and more accurate information about their medications.

The proposed regulations are available for comment via Canada Gazette, Part I until June 7, 2019. Health Canada will consider the comments received and will revise the proposal as needed before publishing the final regulations in Canada Gazette, Part II.

These actions are part of the Government of Canada's commitment to improving the accessibility and affordability of prescription drugs.

Quick Facts

  • Generic drugs account for almost three quarters of the medications dispensed in Canada, but only about one quarter of the expenditures.
  • Initially, approximately 3% of generic drug applications are expected to use this new approach to demonstrate that their generic drug can be substituted for the brand name.All drugs approved by Health Canada must clearly demonstrate that they meet all required criteria for safety, quality and effectiveness. Should new safety concerns arise with any drug, Health Canada will take prompt action.
  • Companies that wish to sell generic drugs in Canada must file a submission to Health Canada for authorization, providing information on:
    • the ingredients, with amounts and specifications;
    • how the drug will be made;
    • how the drug will be tested during manufacture; and
    • how each lot of the drug will be tested before being distributed or sold.


"We need to explore all options for lowering drug costs for Canadians as we improve access to safe medications and medical devices. These changes will allow greater flexibility for generics—and contribute to our goal of improving affordability."

The Honourable Ginette Petitpas TaylorMinister of Health

Associated Links

Access to Generic Drugs


SOURCE Health Canada

Post your Comments

Comments should be on the topic and should not be abusive. The editorial team reserves the right to review and moderate the comments posted on the site.
* Your comment can be maximum of 2500 characters
I agree to the terms and conditions

News A - Z


News Search

Medindia Newsletters

Subscribe to our Free Newsletters!

Terms & Conditions and Privacy Policy.

Find a Doctor

Press Release Category

Press Release Archive

Stay Connected

  • Available on the Android Market
  • Available on the App Store