CDR Update - Issue 68
Patient Input and Notification of Pending Submissions to CDR
The Canadian Agency for Drugs and Technologies in Health (CADTH) is requesting that manufacturers notify the Common Drug Review (CDR) Directorate at least two weeks in advance of submissions that will be filed to CDR. This request relates to the process for patient input to CDR that will be rolled out shortly.
In its consultation with stakeholders regarding the proposed patient input process, the most common feedback to CADTH was that the proposed time frame for submitting patient input (15 business days) was too short. However, the feedback also stated that the patient input process should not increase the overall CDR review time. The intent of the proposed process is to allow the CDR review team to receive the patient input in time to incorporate it into the development of the review protocol. This occurs 15 business days after a submission is received and it is a critical step in the CDR process that clearly focuses the direction of the CDR review. As such, it is essential that issues and outcomes of importance to patients be identified at this stage so that they may be meaningfully incorporated into the entire CDR review process.
As a way to increase the time patient groups have to prepare their submissions (without adding to the total CDR review time), manufacturers are asked to notify CDR of pending submissions at least two weeks before filing the submission. Pending and received submissions will be posted on a patient input section of the CADTH website. E-notification of these submissions will also be sent to people who subscribe to alerts for patient input opportunities. CDR recognizes that manufacturers cannot always predict exactly when a submission will be filed; thus, pending submission dates will be considered tentative.
We trust that this is a reasonable and acceptable approach to providing patient groups with additional time to prepare their submissions. We look forward to receiving notification from manufacturers when a submission is forthcoming.
Details on the information to provide in advance of filing a CDR submission will be included in a subsequent CDR Update in which the implementation of the process for patient input to CDR will be announced.
Confirmation of Materials Sent to CDR
CADTH would also like to advise manufacturers that it is customary practice for CDR to acknowledge the receipt of material within 24 hours. If such an acknowledgement is not received, the manufacturer may wish to follow up to confirm that the materials reached CDR.
Employment Opportunities
CADTH is currently seeking candidates for a variety of openings, including a Health Economist position. If you are interested in learning more about these career opportunities, please visit Careers/Job Listings on the CADTH website.