Health Canada to release clinical trial guidelines for novel coronavirus

Healthcare Canada released two guideline documents designed to streamline the clinical trials for medical devices and drugs related to the COVID-19. The guidance documents support an “Interim order (IO)” that reduces the administrative burden of clinical trials and promotes efficient investigation of drugs and medical devices to treat, prevent, mitigate, or diagnose COVID-19. The scope of the two guidance documents, one for drug clinical trials and one for medical devices, includes trials related to COVID-19 for pharmaceutical and biologic drugs, including blood and blood components; medical devices and combination products are also included.  Health Canada’s IO also reduces the administrative requirements for trials that involve new uses of drugs and medical devices that are already being marketed. Health Canada also stated that they retain oversight flexibility, and may intervene in trials when and if required to safeguard the best interests of clinical trial participants. The guidance documents for COVID-19-related clinical trials of drugs and medical devices will be effective for one year from the date it has been released and posted. 

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