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CDR Update — Issue 93

Last Updated: October 7, 2013
Result type: Reports
Product Line: CDR Update Newsletter

Hard Copy Category 1 CDR Submission Requirements Discontinued
— Effective October 9, 2013

As part of the Canadian Agency for Drugs and Technologies in Health (CADTH) initiative to establish a Common Drug Review (CDR) submission and review process that is based on electronic documents, manufacturers will no longer be required to provide hard copies of Category 1 CDR submission requirements. 

Effective for all CDR submissions received by CADTH on or after October 9, 2013, manufacturers will no longer be required to submit Category 1 CDR submission requirements in hard copy. Please note that this change to hard copy requirement does not affect the manner in which complete submissions are to be sent to CDR-participating drug plans in accordance with Appendix 1 of the Common Drug Review Submission Guidelines for Manufacturers (January 2013).

CDR Submission Requirement Hard Copy or Electronic Format CDR Submission Requirements
Current Effective October 9, 2013
Category 1 submission requirements to CADTH Hard copy and electronic copy as indicated in CDR Submission Guidelines for Manufacturers (January 2013) Electronic copy only as indicated in CDR Submission Guidelines for Manufacturers (January 2013)
Category 1 CDR submission requirements to CDR-participating drug plans As indicated in Appendix 1 of CDR Submission Guidelines for Manufacturers (January 2013) No change
Category 2 CDR submission requirements to CADTH Electronic copy as specified in CDR Submission Guidelines for Manufacturers (January 2013) No change
Category 2 CDR submission requirements to CDR-participating drug plans As indicated in Appendix 1 of CDR Submission Guidelines for Manufacturers (January 2013) No change

Reference to hard copy Category 1 submission requirements throughout the Common Drug Review Submission Guidelines for Manufacturers as well as the Procedure for Common Drug Review documents will be removed with the next revisions of these documents. Sections 4.1.3 and 4.1.4 of the Common Drug Review Submission Guidelines for Manufacturers are updated as follows, and will be incorporated into the next revision of the submission guidelines document. In the interim, any questions should be directed to requests@cadth.ca.

4.1.3 Filing of Submissions

  • Submissions or Resubmissions — with the exception of resubmissions based on a reduced price during the embargo period, which may be submitted by email — must be delivered to CADTH by mail or courier (Appendix 4). Submissions cannot be filed electronically at this time. When initially filing a submission, the manufacturer should deliver only one complete electronic copy of the Category 1 submission requirements to CADTH on CD, DVD, or memory stick with all of the submission requirements included (see Appendix 7F detailing specifications for electronic file format). (Note: Three additional CDs containing copies of the economic model in executable format are also required as part of the initial submission.) The manufacturer should wait until the submission has been deemed complete by CADTH before submitting the required number of electronic copies to CADTH as described in section 4.1.4.
  • When filing Category 2 submission requirements, the manufacturer should deliver one complete copy to CADTH in electronic format (CD, DVD, or memory stick), as specified in Appendix 7F.
  • When both Category 1 and 2 Submission Requirements have been deemed complete, the manufacturer should provide copies to the participating drug plans as described in
    Appendix 1.

4.1.4 Screening of Submission for Completeness; Required Number of Copies

  • An initial screening of the submission is conducted by CADTH within five days of receipt to ensure that it is complete. CADTH verifies whether the submission is complete in accordance with the Common Drug Review Submission Guidelines for Manufacturers.
  • If the submission is incomplete, CADTH sends a notice to the manufacturer advising what information is needed to complete the submission.
  • When the Category 1 requirements in the Manufacturer’s Submission are deemed complete, CADTH sends an acknowledgement to the manufacturer and advises the participating drug plans. Upon receipt of the acknowledgement, the manufacturer must ensure that CADTH is provided with:
    • five additional (for a total of six) complete copies of the Category 1 submission requirements in electronic format on CD, DVD, or memory stick using the folder structure as specified in Appendix 7F. (CADTH may request additional copies if required.) (Note: No further copies of the economic model in executable format that were submitted as part of the initial submission are required.)

      (Note: Only one complete set of the Category 2 Submission Requirements is required by CADTH in electronic format on CD, DVD, or memory stick. No additional copies are required by CADTH after the Category 2 requirements have been deemed complete.)

  • When both Category 1 and Category 2 requirements have been deemed complete, CADTH sends an acknowledgement to the manufacturer and advises the participating drug plans. Upon receipt of the acknowledgement, the manufacturer must ensure:
    • that each drug plan is provided with one or more copies of the submission, or part of it, as directed by the drug plans (Appendix 1).