Pre-submission Meetings

Advance Notification of Submissions

Pharmaceutical manufacturers are encouraged to notify CADTH’s CDR Directorate of pending submissions to allow the Directorate to plan for their review.  Notification within six months of the intended date of filing the submission can be sent to Trinh Luong, Director of Submissions and Operations, at trinhl@cadth.ca or (613) 226-2553, ext. 1492.

Pre-submission Meetings

To facilitate the efficient preparation and filing of submissions, pharmaceutical manufacturers may request pre-submission meetings with CADTH’s CDR Directorate to discuss and clarify submission requirements in general and/or how they relate to a specific drug. Manufacturers are also invited to provide information on drugs in the pipeline so that CDR may plan for upcoming submissions. 

The information and advice provided by the CDR Directorate will be based on the currently available CDR Submission Guidelines for Manufacturers and Procedure for Common Drug Review and will be non-binding.  Manufacturers should ensure that the submission conforms to the requirements in effect at the time the submission is filed. Manufacturers should note that the CDR Directorate may request additional information or material after receipt of the submission in order to complete the CDR review.   

Requests for meetings can be forwarded to Cheryl Fawcett, Executive Assistant for the CDR Directorate at cherylf@cadth.ca or (613) 226-2553 ext. 1251.

Types of Pre-submission Meetings: 

• Pending submissions (a submission to CDR is anticipated to occur within six months)
  The purpose of these meetings is to provide an opportunity for the manufacturer to introduce a drug to the CDR Directorate. Information may be sought from CDR on the submission requirements for the drug, including the approach to the economic evaluation.
• General CDR process meetings
  The purpose of these meetings is for the CDR Directorate to review the CDR submission requirements and procedures with manufacturers or consultants that have not previously submitted a drug to CDR. This information can typically be communicated through emails and teleconferences, with meetings reserved for exceptional situations.

General Guidance: 

• Manufacturers and consultants will be limited to one meeting per pending drug submission.
• Manufacturers are encouraged to discuss more than one submission per meeting and to provide information on drugs in their pipeline.
• All pre-submission meetings will be scheduled for a maximum of one hour.
• At the time of requesting the meeting, manufacturers will be required to provide the name of the drug and its indication, draft agenda, purpose of meeting, and proposed attendees.
• Two weeks before the meeting, manufacturers are required to submit a final agenda, list of attendees, presentation slides, and discussion points to allow CDR staff sufficient time to prepare for the discussion.