Standard Pre-submission Meetings
To facilitate the efficient preparation and filing of submissions for review under the CDR process, manufacturers may request pre-submission meetings with CADTH for pending submissions to be filed within six months. These meetings provide an opportunity for the manufacturer to introduce a drug to CADTH and discuss submission requirements.
Pre-submission meetings are intended to offer the opportunity for dialogue between CADTH staff and manufacturers and are not meant to be consultative in nature, outside of clarifying submission requirements. Manufacturers are also invited to provide information on drugs in their pipeline so that CADTH can plan for future submissions.
Pre-submission meetings are scheduled for a maximum of one hour and applicants are limited to one meeting per pending drug submission.
Early Pre-submission Meetings
CADTH offers opportunities for dialogue between CDR staff and manufacturers earlier in the pre-submission phase, 6 to 12 months in advance of filing, for drug submissions with all of the following characteristics:
- The drug is indicated for a relatively small patient population.
- Clinical data are limited to surrogate end points.
- The natural history of the disease is poorly characterized.
- There are a limited number of clinical trials and they have small sample sizes.
- Treatment has a high cost relative to appropriate comparators.
- The manufacturer has questions regarding the appropriate type of economic analysis to submit.
Manufacturers are advised to send CADTH supporting information for the points aforementioned and an overall rationale for requesting an early pre-submission meeting, as soon as possible after the drug submission has been accepted by Health Canada for review.
A decision to accept a manufacturer's request for an early pre-submission meeting will be made by CADTH on a case-by-case basis.
Pre-submission meetings are intended to offer the opportunity for dialogue between CADTH staff and manufacturers, and are not meant to be consultative in nature.