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CADTH » Search All Products » Common Drug Review » Filing a Submission » Pre-submission Guidance

Pre-submission Guidance

Advance Notification of Submissions

In addition to providing notice of pending submissions for patient input purposes, pharmaceutical manufacturers are encouraged to notify the Canadian Agency for Drugs and Technologies in Health (CADTH) at least three (3) to six (6) months prior to filing submissions so that CADTH may plan for their review. Please send these notifications by email to requests@cadth.ca or call 613-226-2553. 

Pre-submission Meetings

To facilitate an efficient submission preparation and filing process, pharmaceutical manufacturers may request a pre-submission meeting with CADTH.

Types of Pre-submission Meetings: 

  • Pending submissions (submission to be filed within six [6] months). These meetings provide an opportunity for the manufacturer to introduce a drug to CADTH and seek information about the Common Drug Review (CDR) submission requirements for the drug, including the approach to the economic evaluation.
  • General CDR process meetings. In these meetings, CADTH will discuss the CDR submission requirements and procedures with manufacturers or consultants who have not previously submitted a drug to CADTH. As this information can typically be communicated through emails and teleconferences, these meetings are reserved for exceptional situations.

To request a meeting, please send an email to meetingrequests@cadth.ca or call 613-226-2553.

General Guidance: 

  • Manufacturers and consultants are limited to one (1) 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.
  • Pre-submission meetings are scheduled for a maximum of one (1) hour.
  • When requesting the meeting, manufacturers are required to provide:
    • the name of the drug and its indication
    • a draft agenda
    • the purpose of the meeting
    • a list of the proposed attendees.
  • Two weeks before the meeting, manufacturers are required to submit:
    • a final agenda
    • the list of attendees
    • presentation slides
    • discussion points to allow CADTH staff sufficient time to prepare for the discussion.
  • The information and advice provided by CADTH during pre-submission meetings is based on the currently available CDR Submission Guidelines for Manufacturers and Procedure for Common Drug Review, and is 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 CADTH may request additional information or material after receipt of the submission in order to complete the CDR review.