Category 1 requirements for products that undergo a tailored CDR review have been revised. Submissions for new combination products (funded components) and new combination products designated by CADTH to undergo a tailored CDR review will require completion of the revised New Combination Product Submission Template. This revised template includes additional space for results of key clinical studies and publicly available listing status for the individual components of the combination.
In addition, CADTH has issued Category 1 Requirements for New Combination Products with Funded Components or CADTH-Designated Tailored Reviews to replace section 5.1.2 and appendices 8C, 8D, and 9B of the August 2014 Submission Guidelines for the CADTH Common Drug Review. This document identifies new requirements for these submission including copies of sections 2.5, 2.7.1, 2.7.3, and 2.7.4 of the Common Technical Document modules (as applicable), and copies of any source documentation referenced in the tailored review template that are required to verify data provided in the completed tailored review template.
For more information, please see CDR Update – Issue 110 on the CADTH Website.