Posted by Michael Wonder on 02 Oct 2017
Revised procedure for advance notification of pending CDR submissions and resubmissions
28 September 2017 - In September 2016, CADTH updated the advance notification procedure for the Common Drug Review.
Since implementation, CADTH has continuously evaluated the effectiveness of the 120-day advance notification procedure and has carefully considered all feedback that has been received from stakeholders participating in the CDR process. CADTH has received numerous inquiries regarding challenges interpreting and complying with the existing advance notification process.
As a result of these issues, CADTH reduced the advance notification requirement in June 2017 from 120 calendar days to 30 business days for drugs undergoing Health Canada review through an expedited review pathway. Since that time, CADTH completed a more detailed review of the advance notification procedure and identified an overall lack of accuracy with the advance notification data, including frequent and substantial changes to the anticipated filing dates.
