Canada’s Minister of Health Patricia Hajdu ordered an extension last week giving Health Canada an additional 15 days to review clinical trial applications for therapies not related to SARS-CoV-2, the virus behind COVID-19, through November 16, 2020. This occurred because of the enormous volume of COVID-19-related clinical trial applications, which has made life for reviewers at Health Canada more challenging: they simply don’t have the added resources to keep an existing 30-day review period commitment.
30 Day Review Period
Typically, Health Canada takes up to 30 days to review any final clinical trial applications and amendments associated with drugs submitted in association with Division 5 of the nation’s Food and Drug Regulations, reports Michael Mezher with RAPS Regulatory Focus. Normally, if the Canadian agency offers no objection within that period, then the submission is authorized by default, reports Mr. Mezher.
Now, reports RAPS, the agency explained, “The influx of COVID-19-related clinical trials is making it difficult for Health Canada to review all applications and amendments in the 30-day period. Authorizing these by default could expose clinical trial participants to undue risk, as Health Canada would have been unable to complete the health and safety assessment.” Now Health Canada has a 45-day review period, which applies retroactively to those applications and amendments from August 13 till November 16, 2020. The bottom line: patient safety supersedes expediency in Canada.