CADTH Pharmaceutical Reviews Update — Issue 14

Canada's Drug Agency Program Updates

Pending Consultation on Aligned Canada's Drug Agency Review Procedures

In Spring 2020, Canada's Drug Agency will be consulting stakeholders on its aligned procedures for its drug reimbursement reviews. The new procedures will cover the Canada's Drug Agency pan-Canadian Oncology Drug Review, Common Drug Review, and Interim Plasma Protein Product Review processes. The Plasma Protein Product Review is a joint initiative with Canadian Blood Services. Details about the consultation will be announced in a future issue of the Pharmaceutical Reviews Update.

2. Revised Procedure for the Sponsor Review of Initial Canada's Drug Agency pCODR Reports

Initial Canada's Drug Agency pCODR reports will now be issued to the sponsor four business days before the target posting date instead of three business days before the target posting date. This revised process is effective for all submissions and resubmissions discussed at or after the March 2020 pERC meeting. There are no changes to the overall timelines for the review, and sponsors will continue to have three business days to review the reports for the purposes of validating the handling of confidential information and identifying any factual errors. This revision has been implemented to provide Canada's Drug Agency staff with additional time to prepare and post the documents following the sponsor’s review.

This revision is reflected in an updated version of the Procedures for the Canada's Drug Agency pan-Canadian Oncology Drug Review.

Previous Procedure

Three business days prior to the posting of the initial recommendation and Canada's Drug Agency reports, the sponsor and/or the manufacturer of the drug under review (if not the sponsor) will be provided with the clinical report and the summary of the economic report to be publicly posted.

Revised Procedure

Four business days before the posting of the initial recommendation document and Canada's Drug Agency reports, the sponsor and/or the manufacturer of the drug under review (if not the sponsor) will be provided with the clinical report and the summary of the economic report to be publicly posted.

3. Updated Procedural Document for the Canada's Drug Agency Common Drug Review and Interim Plasma Protein Product Review Processes

The Procedures for the Canada's Drug Agency Common Drug Review and Interim Plasma Protein Product Review have been reformatted and updated to correct a minor typographical error in Appendix 5 and to redirect several hyperlinks to alternative locations on the Canada's Drug Agency website. No other changes have been made to the content of the document.