Canada – Guidance : Public release of clinical information for drugs and medical devices in COVID-19 interim orders applications

This guidance is to provide Canadians with access to information on the safety and efficacy/effectiveness of products being used for the COVID-19 pandemic. These products are being imported and sold in Canada under 2 interim orders:

All personal and confidential business information (CBI) will be protected prior to release. The disclosed information will be made publicly available for non-commercial purposes after Health Canada completes its regulatory review process, while adhering to Canada’s Privacy Act.

Providing public access to this information supports Canada’s objective for transparent decision-making. Public access also provides valuable information that may help with the use or development of COVID19 drugs and medical devices.

This guidance document outlines the process for publicly disclosing information in a market authorization application under the 2 interim orders. The process includes:

  • procedures when releasing information
  • types of information that fall under the guidelines for CBI and that may be eligible for redaction
  • protection of personal information..