Generic vs. Brand-name Medicine Prescription Drug Development ... Health Canada’s Role

Making Patient Care Affordable Brand-name Medicine All prescription medication – both generic and brand-name – are reviewed by Health Canada and must meet the same standards for quality, safety, and effectiveness to be authorized for sale. [...] Generic prescription medicines have the same active ingredient, the chemical that produces the desired effect on the body, as the brand-name product. [...] The product formulations and test results are submitted to Health Canada for assessment and in some cases reviewed by external experts and advisory committees to ensure the quality, safety, and effectiveness of the proposed drug. [...] The literature – product descriptions, labels, packaging, and consumer brochures – is reviewed and assessed for accuracy and clarity to ensure they meet Health Canada’s health product communication and advertising regulations. [...] Health Canada’s role Health Canada plays an active role throughout the entire life cycle of a prescription drug - both brand-name and generics – setting manufacturing standards and monitoring and reviewing the product after it is available as a treatment.