October 2020: Canada Regulatory Update

Health Canada published a guidance document, Public release of clinical information for drugs and medical devices in COVID-19 interim orders applications on October 07, 2020.

The document explains the process for the public release of safety and efficacy/effectiveness information reviewed under ‘interim order respecting the importation, sale and advertising of drugs for use in relation to COVID-19 (September 16, 2020)‘ and ‘interim order respecting the importation and sale of medical devices for use in relation to COVID-19(March 18, 2020)‘. Information in applications that have been authorized, including those authorized and then revoked, is in scope for public release. Information in applications that are refused and were never authorized is out of scope for public release.

A final redacted and anonymized package is published on Health Canada’s Clinical Information Portal within 120 calendar days from the day an authorization is issued. This process is in accordance with the timelines given in the Public Release of Clinical Information (PRCI) guidance document.

Publication of safety and efficacy information used to support drug interim order applications

  • The first 60 days of the 120-day publication process are allocated for the company to review the clinical information. The company uses the Proposed Redaction Control Sheet (Appendix E, Public Release of Clinical Information (PRCI) guidance document) to propose any redaction of confidential business information (CBI).
  • Within 30 days of receiving the proposal package, Health Canada will complete and return the assessment of the proposed CBI redactions and anonymization methodology for the protection of personal information.
  • The manufacturer will be given 15 days to make the revisions and resubmit.
  • The final assessment will be sent to the manufacturer within 5 days of receiving the revised package.
  • The manufacturer must format and submit the final redacted and anonymized clinical documents within 5 days of receiving the final assessment.
  • The final redacted documents will be published within 5 days of receiving the final sequence.

Publication of safety and effectiveness information used to support medical device interim order applications

  • The CBI and personal information from the interim order application, for which information request is received, will be assessed and redacted by Health Canada.
  • A copy of the release package will be sent for the manufacturer’s review. Any further proposed redactions by the manufacturer must be received within 14 calendar days.
  • Any further redactions proposed by the manufacturer will be assessed.
  • In-scope documents will be published within 120 days following receipt of the request.

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