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 Procedures for the CADTH Common Drug Review and Interim Plasma Protein Product 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 CADTH Common Drug Review and Interim Plasma Protein Product Review processes. 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 its drug review processes, please consult the Fee Schedule for CADTH Pharmaceutical Reviews for complete details.
The following templates are to be used by sponsors in accordance with the requirements outlined in the Procedures for the CADTH Common Drug Review and Interim Plasma Protein Product Review.
- Pre-submission meeting request form
- Advance notification form
- Resubmission eligibility form
- Submission eligibility form
- Tailored review application form
- Request for deviation from economic requirements form
Templates for Category 1 Requirements
- Application overview template
- Executive summary template for a submission
- Executive summary template for a resubmission
- Table of studies template
- Letter for sending NOC or NOC/c to CADTH
- Declaration letter template
- Number of patients accessing new drugs
- Implementation plan for a cell or gene therapy
Templates for Comments, Redactions, and Reconsideration
- Reconsideration request template
- Sponsor comments template
- Identification of confidential information template