CDR Update — Issue 129

CADTH

11 October 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 will be implementing the proposed revision to the resubmission eligibility criteria and a new randomised controlled trial will no longer be required to be considered eligible to file a resubmission based on improved efficacy. CADTH is currently finalising the revised process for screening and reviewing resubmissions. Complete details of the revised resubmission process for Common Drug Review 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-randomised study designs (e.g., table of studies)

Read CADTH news article

Michael Wonder

Posted by:

Michael Wonder