Email: For medical devices: Bureau of Investigational Testing Authorization, Special Access Program and Post-Market Surveillance, Medical Devices Directorate. Email: For biologics and radiopharmaceuticals: Office of Regulatory Affairs, Biologic and Radiopharmaceutical Drugs Directorate. For pharmaceutical drugs: Office of Clinical Trials, Therapeutic Products Directorate.The REB does not provide advice to external researchers.įor further information regarding the regulatory requirements, investigators may contact: The Health Canada-PHAC REB only reviews clinical trials being undertaken and conducted by investigators from Health Canada or PHAC. Health Canada requires that the drug sponsor (individual, corporate body, institution or organization) and medical device manufacturer/importer undertaking the clinical study obtain institutional Research Ethics Board approval prior to opening the clinical trial in Canada, in accordance with Division 5 of the Food and Drug Regulations, Part 4 of the Natural Health Product Regulations or Part 3 of the Medical Devices Regulations. This includes health products not authorized/licenced in Canada, as well as Canadian market authorized drugs and licensed medical devices and natural health products that are being investigated for potential use outside their approved indication. Health Canada regulates the sale and importation of certain drugs, medical devices and natural health products that will be used in human clinical trials. Applicants are advised to follow these instructions closely when drafting their protocols. The research protocol instructions on the REB website provide additional information relevant to each of these elements. ![]() Thus, when assessing whether a proposal meets the ethical requirements for research involving humans, the REB focuses on the following five elements:Īpplicants should ensure that their research protocols provide sufficient detail so that the REB can appropriately assess the proposal against these criteria.
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