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CADTH Procedures and Templates for the Common Drug Review and Interim Plasma Protein Product Review Processes

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. 

Templates

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 Phase

Templates for Category 1 Requirements

Templates for Comments, Redactions, and Reconsideration

CADTH Submission Templates