Canada – The Canadian application process and alternate pathway for COVID-19‒related clinical trials

This article offers an overview of the clinical trial application process and guidance on the regulatory obligations pursuant to Part C, Division 5, of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects” in Canada. The authors focus on clinical trial applications only for biologics (schedule D) and pharmaceuticals (schedule F). They provide information on a range clinical trial submission requirements and communication with Health Canada’s relevant directorates and offices…