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The purpose of this notice is to advise stakeholders that Health Canada is proposing to: maintain the flexibilities and regulatory oversight provided by the Interim order respecting clinical trials for medical devices and drugs relating to COVID-19 until at least the fall of 2021, and bring forward regulatory amendments that would allow the flexibilities under the Interim Order to continue after the fall of 2021.

Sponsors of COVID-19-related drug and vaccine clinical trials can choose between 2 different processes: existing process outlined in the Food and Drug Regulations or process outlined in the new interim order for clinical trials for medical devices and drugs related to COVID-19.

The table below lists the clinical trials authorized by Health Canada for COVID-19-related medical devices. Authorization is done through the Medical Device Regulations or the Interim Order No. 2 for clinical trials for medical devices and drugs related to COVID-19.

IO No. 2 supports Canada’s continued focus on dealing with the significant risk that COVID-19 continues to pose to the health and safety of Canadians.

Manufacturers of medical devices intended to treat COVID-19 can choose between 2 different processes to apply for a trial authorization: process for investigational testing outlined in the Medical Devices Regulations or process outlined in the new interim order for clinical trials for medical devices and drugs related to COVID-19.

Manufacturers of medical devices intended to treat COVID-19 can choose between 2 different processes to apply for a trial authorization: process for investigational testing outlined in the Medical Devices Regulations or process outlined in the new interim order for clinical trials for medical devices and drugs related to COVID-19.

Currently, the treatment of COVID-19 includes supportive care and treatment of any secondary infections, such as pneumonia. There are no drugs or vaccines approved, but there are now 18 clinical trials authorized in Canada with diagnostic equipment, supportive care and/or treatments for COVID-19.

The purpose of this document is to assist in planning immunization clinics for COVID-19 vaccines during the COVID-19 pandemic.

The Interim Order (IO) No. 2 continues to support the optional pathway introduced by IO No. 1 to facilitate clinical trials for potential COVID-19 drugs and medical devices.

The tables below list the COVID-19-related clinical trials which have been authorized by Health Canada through the Food and Drug Regulations or the Interim order No. 2 for clinical trials for medical devices and drugs related to COVID-19.