It is important that applicants pay careful attention to CDR documentation to ensure a smooth and efficient process. Do not download and archive documentation, as it is subject to change. Please use the latest versions posted on this page.
Guidelines and Procedures
The Submission Guidelines for the CADTH Common Drug Review provide guidance to manufacturers in the preparation of applications for the review of submissions and resubmissions for drugs through the CDR process.
The Procedure for the CADTH Common Drug Review details the procedures to be followed by all participants in the review.
CADTH has implemented a new fee structure that applies to both the Common Drug Review and pan-Canadian Oncology Drug Review programs. The new Guidelines on Application Fees for CADTH Pharmaceutical Reviews replace the separate application fee guidelines which previously existed for each program.
The aforementioned two documents must be read in conjunction with one another, as well as any issues of the CDR Update subsequent to CDR Update – Issue 108. Revisions from all applicable CDR Update issues 86 to 108 are included in the August 2014 version of the Submission Guidelines for the CADTH Common Drug Review.
The following templates are to be used by applicants in accordance with the requirements outlined in the Submission Guidelines for the CADTH Common Drug Review.
- Pre-submission Meeting Request Form
- CADTH Common Drug Review Advance Notification Form
- New Combination Product Considerations Form
Templates for Category 1 Requirements
- Application Overview Template
- Executive Summary Template for a Submission
- Executive Summary Template for Resubmission
- Table of Studies Template
- Letter Confirming Disclosure of All Known Unpublished Studies
- Number of Patients Accessing New Drug
- Commitment to Honour Submitted Price Letter
- Unrestricted Sharing of Information Letter
- Letter for Sending NOC or NOC/c to CADTH
- Letter for Finalized Category 1 Requirements
- Biosimilars Declaration Letter