It is important that sponsors pay careful attention to CADTH documentation to ensure a smooth and efficient process. Do not download and archive documentation, as it is subject to change.
Guidelines and Procedures
The Procedure and Submission Guidelines for the CADTH Common Drug Review details the procedures to be followed by all participants in the review and provides guidance to sponsors in the preparation of submissions and resubmissions through the CDR process. This document must be read in conjunction with any CADTH Pharmaceutical Review Updates issued after the date of publication.
CADTH has implemented a fee structure that applies to both the Common Drug Review and pan-Canadian Oncology Drug Review programs. The Guidelines on Application Fees for CADTH Pharmaceutical Reviews replace the separate application fee guidelines which previously existed for each program.
The following templates are to be used by sponsors in accordance with the requirements outlined in the Procedure and Submission Guidelines for the CADTH Common Drug Review.
- Pre-submission Meeting Request Form
- Advance Notification Form
- New Combination Product Considerations Form
- Resubmission eligibility form
- Submission eligibility 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 for Sending NOC or NOC/c to CADTH
- Declaration letter template
- Number of Patients Accessing New Drugs
Templates for Comments, Redactions, and Reconsideration
- Reconsideration request template
- Sponsor comments template
- Identification of confidential information template