1. Revised Procedure for the CADTH Common Drug Review Resubmissions
In August 2017, CADTH invited stakeholder comments and feedback on a proposal to revise the resubmission requirements for its Common Drug Review (CDR) and pan-Canadian Oncology Drug Review (pCODR) programs. Based on feedback from stakeholders, CADTH has implemented the proposed revision to the resubmission eligibility criteria for the CDR process and a new randomized controlled trial is no longer required to be considered eligible to file a resubmission based on improved efficacy. During the consultation, stakeholders expressed the need for a process in which the eligibility of a resubmission can be confirmed by CADTH before filing a complete package of category 1 requirements. In response to this feedback, CADTH has implemented a new mandatory CDR process for evaluating the eligibility of potential resubmissions.
Applicants should consult the following document for complete details regarding the revised resubmission procedure: Resubmission Criteria for the CADTH Common Drug Review
To ensure fair access to the CDR process for new drug submissions, CADTH may limit the number of resubmissions that can be made and/or initiated within a defined period of time. This decision will be made by CADTH based on the availability of resources, and will be communicated to stakeholders via a CDR Update.
Important note: The revised process described in this update is for the CDR program; the revisions are not applicable to the pCODR program at this time.
2. Industry Fees are Applicable to all CDR Resubmissions
All resubmissions that are filed by manufacturers on or after January 2, 2018 will be subject to an application fee. A schedule B fee will apply for a resubmission based on new clinical information with or without new cost information and a schedule D fee will apply for a resubmission based only on new cost information.
3. Revised Table of Studies Template
CADTH has updated the table of studies template to accommodate non-randomized study designs. Applicants are required to use this updated template for all CDR submissions and resubmissions filed on or after January 2, 2018.