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All drugs that are authorized for sale in Canada must undergo a similar review process and be approved by Health Canada (the federal regulatory authority). This federal agency is responsible for assessing the safety, efficacy and quality of all medicines. There are no differences in the quality and safety standards that generic drugs and brand-name drugs must meet.
When a generic drug is reviewed, the manufacturer has to demonstrate that the generic drug performs similarly to the brand-name drug and that the generic drug delivers the same amount of medicinal ingredient at the same rate as the brand-name version.
In many cases, generic drugs match the size, shape, colour and taste of their brand-name counterparts. In other cases, there are slight differences. The important thing is that the generic medicines must have the same active ingredients and be “bioequivalent,” meaning they work the same way in your body as their brand-name counterparts. The differences in appearance do not affect the safety or effectiveness of generic medications.
The standards for bioequivalence in Canada are built upon internationally recognized standards and the criteria are among the highest in the world. Health Canada Scientists ensure that the standards for bioequivalence are adhered to and kept up to date as they work closely with an expert panel of Scientists, Physicians and Pharmacists from across Canada. Health Canada also regulates the non-medicinal ingredients, such as fillers and preservatives, for both brand-name and generic drugs and they are subject to the same approval process.
All provincial and territorial governments and hospitals in Canada recognize Health Canada’s declaration of equivalence and use generic prescription medicines wherever possible.
No. Brand-name drugs are developed under patent protection. In most cases, generic drug companies apply to Health Canada to sell a generic version after the brand-name drug's patent(s) expire.
Over the next few years, as more patents expire, generic versions of several top-selling brand-name drugs are expected to become available.
An active pharmaceutical ingredient (API) is the component of a drug responsible for the medication's effect. Generics are required by Health Canada to contain the same APIs as their brand-name counterparts.
Inactive ingredients, such as fillers and colourants, can give a drug its colour, size and shape. Generics must contain the same active ingredients as brand-name drugs but they do not have to be made with the same inactive ingredients, as these do not affect the therapeutic effect of the drug.