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. This document must be read in conjunction with any CADTH Pharmaceutical Review Updates issued after the date of publication.
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 applicants in the preparation of submissions and resubmissions through the CDR process. This document must be read in conjunction with any CDR Updates subsequent to CDR Update – Issue 137.
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 applicants in accordance with the requirements outlined in the Procedure and 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
- 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 for a standard or tailored review
- Declaration letter template for a biosimilar review
- Number of Patients Accessing New Drugs
Templates for Comments and Redactions
- Manufacturer comments for a standard or tailored review
- Identification of errors or omissions for a biosimilar review
- Identification of Confidential Information Template