Canada Profile Updated in ClinRegs

August 20, 2020

The Canada profile in ClinRegs now includes the following updates:

COVID-19 Related Information

On August 13, 2020, Health Canada issued a Ministerial Order that temporarily extended the default period to review non-COVID-19 clinical trial applications and amendments by from 30 days to 45 days. More information is available in a Notice issued on August 14, 2020.

On August 5, 2020, Health Canada updated Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors, which provides guidance related to protocol deviation, participant safety, site monitoring, participant eligibility, pausing a study, and shipment of investigational products directly to patients. The guidance now notes the following:

  • Until further notice, sponsors do not need to file clinical trial site forms for non-COVID trials
  • Until further notice, sponsors do not need to submit notifications for non-safety-related changes for non-COVID trials