Updates to Canada’s CDR Guidelines
On 9th June, CADTH issued an update to their CDR process, along with additional reminders for industry.
The updates include:
- revised notification period for the CDR advanced notification process from 120 calendar days to 30 business days
- revised date for confirmation of anticipated filing dates from one month in advance to 30 business days
- guidance for subsequent entry non-biological complex drugs
- revised documentation for CDR resubmissions
