Filing a Submission

Submission Guidelines

The Common Drug Review Submission Guidelines for Manufacturers:

provide guidance for pharmaceutical companies preparing submissions to the Common Drug Review (CDR) at the Canadian Agency for Drugs and Technologies in Health.
set out the information required in a manufacturer’s submission, consolidating the requirements of CADTH and the participating public drug plans.

CADTH reviews new drugs, new combination products, and drugs with new indications through the CDR process.

Notice of Pending Submissions

To provide patient groups with additional time to file patient input submissions, manufacturers are asked to notify CADTH at least two (2) weeks prior to filing submissions. The Manufacturer’s Notice of Pending Submissions template should be used for providing the information about pending submissions. The information will be included in the Calls for Patient Input table on this website and in e-alerts to subscribers. (Note: Information about pre-NOC priority review submissions will be included in the table.)

Pre-submission Information

To facilitate the efficient preparation and filing of submissions, pharmaceutical manufacturers may request a pre-submission meeting with CADTH to discuss submission requirements. Manufacturers are also invited to provide information on drugs in their pipeline so that CADTH may plan for future submissions. See Pre-submission Guidance for more details.

Templates

For the convenience of individuals preparing submissions, the following Microsoft Word templates are provided to address the specific information required under the Submission Guidelines.

Targeted Canadian Drug Expert Committee Meeting

The date on which the Canadian Drug Expert Committee (CDEC) is tentatively scheduled to consider a drug is based on the date the drug submission is received by CADTH, the date it is deemed complete, and other factors. The following table helps manufacturers determine the tentative date for when their submission will be considered. When CADTH receives a large number of submissions within a short time frame, the organization may need to queue submissions in accordance with the Common Drug Review Submission Guidelines for Manufacturers, section 4.1.5. Manufacturers are therefore advised to file submissions as soon as possible rather than target the dates listed in the table that follows.

Please note that 10 business days are allotted for assessing resubmissions and pre-NOC priority review submissions for completeness as opposed to five (5) business days for submissions. The cut-off date for receiving resubmissions and Pre-NOC priority review submissions, then, is five (5) days earlier than for submissions.

For Submissions Received Between		If Deemed Complete By	Targeted CEDAC Meeting Date
2011-Jul-07	2011-Aug-23	2011-Aug-30	2012-Jan-18
2011-Aug-24	2011-Sep-21	2011-Sep-28	2012-Feb-15
2011-Sep-22	2011-Oct-26	2011-Nov-02	2012-Mar-21
2011-Oct-27	2011-Nov-22	2011-Nov-29	2012-Apr-18
2011-Nov-23	2011-Dec-20	2012-Jan-04	2012-May-16
2011-Dec-21	2012-Jan-31	2012-Feb-07	2012-Jun-20
2012-Feb-01	2012-Feb-28	2012-Mar-06	2012-Jul-18
2012-Feb-29	2012-Apr-30	2012-May-07	2012-Sep-19
2012-May-01	2012-May-28	2012-Jun-04	2012-Oct-17
2012-May-29	2012-Jul-03	2012-Jul-10	2012-Nov-21

section 4.1.5. Manufacturers are therefore advised to file submissions as soon as possible rather than target the dates listed in the table that follows.