Revised procedure for the CADTH Common Drug Review resubmissions

CADTH

13 November 2017 - In August 2017, CADTH invited stakeholder comments and feedback on a proposal to revise the resubmission requirements for its Common Drug Review and pan-Canadian Oncology Drug Review programs. 

Based on feedback from stakeholders, CADTH has implemented the proposed revision to the resubmission eligibility criteria for the CDR process and a new randomised 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.

Read CADTH CDR Update

Michael Wonder

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Michael Wonder