On October 11, 2017, the Canadian Agency for Drugs and Technologies in Health (CADTH) released a new CDR Update (Issue 129). Based on feedback from stakeholders, CADTH will be implementing the proposed revision to the resubmission eligibility criteria and a new randomized controlled trial will no longer be required to be considered eligible to file a resubmission based on improved efficacy. Complete details of the revised resubmission process for CDR will be announced in November 2017 and will include the following:
- revised eligibility criteria for resubmissions based on new clinical information
- a revised process for evaluating the eligibility of potential resubmissions
- updated category 1 requirements to accommodate non-randomized study designs
Important note: The revised process will be for the CDR program; the revisions will not be applicable to the pCODR program at this time. Updates regarding the pCODR program will be communicated via a pCODR Update at a later date.
For further information, please refer to the CADTH website.