Proposed changes offer Canadian patients more choices
April 4, 2019 Ottawa, ONTARIO Health Canada
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.
