Clinical Trial Regulations

In most cases, Health Canada is not involved in conducting clinical trial research, but only in the regulation of the sale (distribution) and importation of non-approved drugs for use in human clinical trials. This applies to drugs not marketed in Canada and for approved drugs used outside of the parameters of the Notice of Compliance. As part of that regulatory function, the Therapeutic Products Directorate (TPD) and the Biologics and Genetic Therapies Directorate (BGTD), require that the sponsor (individual, corporate body, institution or organization) undertaking the research, obtain the approval of an appropriate Research Ethics Board before the clinical trial begins, in accordance with the Division 5 of the Food and Drugs Act and Regulations.

However, there may be circumstances where Health Canada will be involved in conducting clinical trials. In such situations, an application to Health Canada's Research Ethics Board (REB) for an ethical review of the proposed research by the REB will be required in order to proceed.

Guidance for sponsors of clinical trials including the process of filing a clinical trial application and the responsibilities of the sponsor can be found in the document "Guidance for Clinical Trial Sponsors".

ICH Harmonised Tripartite Guideline

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration. The "Guidelines for Good Clinical Practice" is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects, and is adopted by Health Canada which applies to drug and device studies undertaken by industry or with industry support.

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