Alignment of terminology

CADTH

9 January 2020 - CADTH is aligning the terminology in the single drug review processes as follows:

  • Submissions that are withdrawn and re-filed in the pCODR process will no longer be classified as resubmissions by CADTH and will be classified as submissions. Resubmissions will only apply in situations where CADTH has completed a review and issued a final recommendation for the drug and indication under review.
  • CADTH will now use the term ‘accepted for review’ rather than ‘deemed complete’ for pCODR submissions and resubmissions. This is reflected in the Fee Schedule for CADTH Pharmaceutical Reviews.
  • CADTH has aligned milestone 1 for its Common Drug Review (CDR) and pan-Canadian Oncology Drug Review (pCODR) processes in the Fee Schedule for CADTH Pharmaceutical Reviews (initiation of review is now used as milestone 1).
  • Submissions filed before market authorisation by Health Canada will be simply be referred to as pre-Notice of Compliance (NOC) submissions and those filed after market authorisation will be referred to as post-NOC submission (there will no longer be a distinction between NOC or NOC/c [with conditions] in the description of submission types).

These revisions are effective immediately and will be reflected on the CADTH website and in the procedural documentation for the single drug review processes.

Read CADTH Pharmaceutical Reviews Update — Issue 12

Michael Wonder

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Michael Wonder