subject: How Are Canada Drugs Reviewed? [print this page] How Are Canada Drugs Reviewed? How Are Canada Drugs Reviewed?
According to Statistics Canada, retail sales of Canada drugs that also include vitamins and other health supplements surpassed the $20 billion mark for the first time in 2005. All Canada drugs have to undergo a tough review process before they reach the market or are granted a market authorization certificate by the regulatory authorities. Various drug products sold through pharmacies include prescription and non prescription medicines, disinfectants and sanitizers. Canada Drugs Review Process Health Canada's Therapeutic Products Directorate or TPD is the national authority that regulates, evaluates and monitors the safety, efficacy and quality of therapeutic and diagnostic products sold in the country. The whole review process involves several steps.
Receipt of a New Drug Submission Application: When the sponsor of a drug decides that it would like to market a drug in Canada, it needs to file a new drug submission application with the TPD. This application should be accompanied by information that can prove the drug's safety, effectiveness and quality. This information includes the results of various preclinical and clinical studies, details related to the production process of the drug, packaging and labeling details and all information related to therapeutic claims and side effects.
Review of Submitted Information: This is done through an analysis of the information provided and with the help of external consultants and advisory committees.
Review of Information Related to Product Labeling: The TPD reviews the information that the sponsor proposes to provide to healthcare practitioners and consumers. This includes information on the label of the Canada drugs and the brochures to be distributed for creating awareness.
Comparison of Benefits and Risks: If the review reveals that the benefits outweigh the risks and that the risks can be mitigated, the drug is issued a Notice of Compliance (NOC) and a Drug Identification Number (DIN) which permits the sponsor to market the drug in Canada and indicates that the drug has been officially approved.
Conduct Laboratory Tests of Certain Products: Certain potential Canada drugs may be tested in Health Canada's laboratories before their market authorization has been granted.
A thorough review of the application and the accompanying information is done by the TPD before giving the necessary approval for the marketing of the drug. However, if there is insufficient evidence to support the safety, efficacy or quality claims, the TPD does not grant a marketing authorization of the drug. If the TPD decides not to grant a marketing authorization, the sponsor has the opportunity to supply additional information, to re-submit its submission at a later date with additional supporting data, or to appeal the TPD's decision.
