Proposed changes offer Canadian patients more choices
OTTAWA, April 4, 2019 /CNW/ - Canadians want improved accessto 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,
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.
"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 genericsand contribute to our goal of improving affordability."
The Honourable Ginette Petitpas TaylorMinister of Health
Access to Generic Drugs
SOURCE Health Canada
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