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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. 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.

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.

Templates

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 Phase

Templates for Category 1 Requirements

Tailored CDR Review Templates