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CDR Guidelines, Procedures, and Templates

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. 

Templates

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 Phase

Templates for Category 1 Requirements

Templates for Comments, Redactions, and Reconsideration

CDR Submission Templates