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 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. CADTH is currently finalizing the revised process for screening and reviewing resubmissions. 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 (e.g., table of studies)
Important note: The revised process targeted to be released in November 2017 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.