Filing a Submission

Submission Guidelines

The Common Drug Review Submission Guidelines for Manufacturers provide guidance to pharmaceutical companies preparing drug submissions to CADTH's Common Drug Review (CDR) Program.

The guidelines also identify specific submission requirements – consolidating all the requirements for the CDR and participating public drug plans.

The CDR reviews new drugs, new combination products, and drugs with new indications.

Pre-submission Meetings

To facilitate the efficient preparation and filing of submissions, pharmaceutical manufacturers may request a pre-submission meeting with CADTH’s CDR Directorate to discuss submission requirements. Manufacturers are also invited to provide information on drugs in their pipeline so that CDR may plan for future submissions. See Pre-submission Meetings for more details.

Templates

For the convenience of individuals preparing submissions, the following Microsoft® Word templates are provided to address the specific information required under the Submission Guidelines and for the patient input initiative.

• Table for Notice of Pending Submissions
• Table for listing published and unpublished studies
• Letter confirming disclosure of all known unpublished studies
• Letter confirming ability to supply
• Letter authorizing unrestricted sharing of information
• Letter of Authorization (Pre-NOC Priority Review Submissions only)
• Information to be Sent to CDR (Pre-NOC Priority Review Submissions only)
• Template for Combination Products (Funded Components)
  

Targeted CEDAC Meeting

The date that the Canadian Expert Drug Advisory Committee (CEDAC) is tentatively scheduled to consider the CDR review of a drug, is based on the date the drug submission is received by CDR, the date it is deemed complete, and other factors. The following table helps manufacturers determine the tentative date when their submission will be considered.

Please note that 10 business days are allotted for assessing resubmissions for completeness as opposed to five business days for submissions. Thus, to meet the “deemed complete” date listed in the table, the cut-off date for receiving resubmissions is five days earlier than for submissions.