CDR Consultations – July 2007

June 29, 2007

Purpose

The Canadian Agency for Drugs and Technologies in Health invites all interested parties to provide feedback on three potential areas for change in the Procedure for Common Drug Review (CDR) and the CDR Submission Guidelines for Manufacturers.

The issues to be addressed and the proposed solutions are outlined below. Please provide comments to cdrfeedback@cadth.ca by July 31, 2007.

Consultation Items

1. Priority Review

Issue: The CDR Priority Review designation currently impacts the submission review order but it does not reduce the CDR review timelines.

Proposal: Shorten the CDR priority review process by 8 business days through the following:

• decreasing the manufacturer’s time for comment to 3 business days (from 7 business days)
• decreasing the reviewer’s time for response to 3 business days (from 7 business days)
• reducing the length allotted for manufacturer’s comments on CDR review reports to 3 pages (from 6 pages).

2. Clinical Study Reports

Issue: Some submissions to CDR do not contain all of the trial data or trial design information required for the review.

Proposal: Include the Clinical Study Report for randomized controlled trials on the approved indication(s) and approved dose(s) in a searchable CD format as a Category 1 CDR Submission Requirement.

The Clinical Study Reports are helpful to CDR as they contain the detailed trial information required for CDR review purposes and are in a consistent format based on the International Conference on Harmonization (ICH).

3. Health Canada Reviewer’s Report

Issue: CDR routinely asks manufacturers to provide the Health Canada Reviewer’s Report as additional information.

Proposal: Designate the Health Canada Reviewer’s Report as a Category 1 CDR Submission Requirement.