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.
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 Taylor
Minister of Health