CDR Update - Issue 29

Clarification Regarding Submissions for New Indications

The Common Drug Review (CDR) program wishes to notify stakeholders of a change to Section 4 of the CDR Submission Guidelines for Manufacturers. Section 4 of the current guidelines, dated May 2006, states:

“A Drug can undergo only one type of CDR Review during the same period. For example, if a Drug is at any stage of the review process as a Submission, the CDR Directorate will not review the Drug concurrently as a Resubmission.”

This particular section was written to address a resubmission based on new information (as defined in the submission guidelines), and there are additional details in the guidelines to cover that kind of situation. However, there may be grounds for an additional submission when a drug has received Health Canada approval for a new indication that differs substantially from an indication already submitted to CDR.

To accommodate such situations, Section 4 will be changed to read:

“A Drug can undergo only one type of CDR Review during a period. For example, if a Drug is at any stage of the review process as a Submission, the CDR Directorate will not review the Drug concurrently as a Resubmission. An exception to this may be made when the basis for the Re-submission is a new indication; CDR will assess this situation on a case-by-case basis considering factors such as: where in the CDR review process the previous submission is, how distinct the new indication is from the indication under review, and the resources required for the CDR to review the new indication.”

A new version of the CDR Submission Guidelines for Manufacturers that incorporates this change will be posted on the CADTH web site shortly.

Enhanced Web Search Tool for CDR Information

CADTH has refined its web search tool for accessing information from the CDR program and made the tool easier to find. It is now available directly from the main web menus for CDR, under the heading Search CDR Drug Database (http://www.cadth.ca/index.php/en/cdr/search).

The tool provides access to the database of formulary listing recommendations made by the Canadian Expert Drug Advisory Committee (CEDAC) to Canada’s public drug plans as part of the CDR process. Detailed reports on the status of drug submissions under review are also available in the database.

The search tool displays a summary of information for each submission to CDR, such as the drug’s generic name, brand name and manufacturer. It also lists what the drug is indicated for, the date the submission was received by CDR, the status of the submission (e.g. active versus completed), and the date the recommendation was issued. There are multiple options for displaying and sorting this information.

A particularly useful addition is the recommendation summary field which indicates, in brief, the CEDAC recommendation for each completed drug submission (e.g. “List” on public formularies versus “Do not list”). The full CEDAC recommendations, complete with reasons for the recommendations, remain available in pdf format.

Another notable addition to the search tool is a counter that displays, at a glance, the number of submissions in the queue. For example, clicking on the active tab shows the number of active submissions out of the total number of submissions received by CDR since the program’s inception. See the screen capture below.

If you have any suggestions for further improvements to the search tool for the CDR drug database, please contact: CDRinfo@cadth.ca.

CDR Industry Session

In the past few years, the CDR program has hosted an industry session in the fall. We have decided to postpone the next session until the spring of 2007 when there will be an opportunity to present program initiatives that are underway, but which are currently at too preliminary a stage to meaningful discuss. They include the addition of public members to CEDAC, the collaborative project between CDR and Health Canada regarding initiation of reviews pre-NOC (Notice of Compliance), and the experience with the recently implemented changes to the CDR Submission Guidelines for Manufacturers.

CDR continues to be interested in maintaining an ongoing dialogue with pharmaceutical manufacturers and industry stakeholders. We invite suggestions for other topics for the next CDR Industry Session (e-mail suggestions to CDRinfo@cadth.ca). Information regarding the date, location and agenda of the meeting will be released in the coming months.