CDR Update - Issue 32

February 8, 2007

In This Issue

  • Queuing of Submissions to the Common Drug Review (CDR)

The CDR order of review is noted in the Procedure for Common Drug Review (May 2006, Section 1.1.8, http://www.cadth.ca/media/cdr/process/cdr_procedure_e_may2006.pdf) and the Common Drug Review Submission Guidelines for Manufacturers (September 2006, Section 4.1.5, http://www.cadth.ca/media/cdr/process/CDR%20Submission%20Guidelines%20July%202007_final.pdf).

In brief, the documents indicate that the order in which the CDR reviews submissions is:

  • submissions or resubmissions that are assigned a priority review status
  • requests for reconsideration
  • manufacturers’ submissions, Advisory Committee on Pharmaceuticals (ACP) or drug plan submissions for new drugs or new combinations
  • ACP or drug plan initiated drug-related reviews
  • requests for advice
  • resubmissions

The purpose of this CDR Update is to remind manufacturers that in periods when the number of new submissions and/or resubmissions significantly exceeds the projected volumes, the CDR places the submissions in a tiered queue.

Submissions are processed in the order received (first-come, first-served basis) and in accordance with the above order of review. Typically, the CDR and CEDAC can accommodate a total of three new submissions or resubmissions per CEDAC meeting.

Even if a submission is received before the cut-off date noted on our web site with respect to a specific CEDAC meeting, in times of peak activity, the submission may be queued. Therefore, manufacturers are encouraged to file their submissions to the CDR as soon as possible rather than focusing on the cut-off dates.

The CDR removes submissions from the queue as soon as resources become available. The affected manufacturer is notified and the status on the CADTH web site is updated.

Advance Notification of Submissions; Pre-submission Meetings

To help the CDR plan for upcoming submissions, manufacturers are encouraged to notify the CDR Directorate through e-mail of pending submissions.

In order to facilitate the most efficient preparation and review of submissions, when appropriate, the CDR Directorate is available for one-hour pre-submission meetings with manufacturers to discuss submission requirements and issues specific to the drug. Requests for such meetings can be forwarded to Cheryl Fawcett, Executive Assistant for the CDR Directorate. Cheryl can be reached at: cherylf@cadth.ca or (613) 226-2553, ext. 251.

Personnel News

Barb Shea, formerly Vice-President of the CDR and the Canadian Optimal Medication Prescribing and Utilization Service (COMPUS) programs, now focuses exclusively on COMPUS.

Mike Tierney has been promoted from Senior Director to Vice-President of the CDR. He can be contacted at: miket@cadth.ca or (613) 226-2553, ext. 315.

Karen Lee has been promoted from Health Economist to Manager of Health Economics, CDR.

Cheryl Fawcett, who formerly supported both the CDR and COMPUS programs, is now Executive Assistant for the Vice-President, CDR.

The CDR Directorate is currently recruiting for a Clinical Reviewer. If you’re interested in joining our growing team of professionals, visit career opportunities on the CADTH web site.

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