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CADTH » Search All Products » Common Drug Review » CDR Update » CDR Update - Issue 27

CDR Update - Issue 27

CDR Procedures and Submission Guidelines Revised - to Take Effect September 1, 2006

The Procedure for Common Drug Review and the Common Drug Review Submission Guidelines for Manufacturers have been revised and posted on the Common Drug Review section of the CADTH web site. The documents are dated May 2006.

All submissions to CDR must comply with the new CDR submission guidelines as of September 1, 2006. However, manufacturers are encouraged to file submissions in accordance with the new guidelines starting immediately, if possible.

Proposed changes to the documents were presented to stakeholders, including participating drug plans, the pharmaceutical industry, CDR reviewers, the Canadian Expert Drug Advisory Committee and other interested parties in the fall. Feedback from these groups was incorporated into the final documents.

Key changes to both documents include:

  • clarification of “new information” for resubmissions
  • addition of procedures for withdrawals
  • addition of procedures for resubmissions
  • final versions of CDR reviews to be sent to manufacturers for information (in addition to earlier versions sent for comments)
  • extension to embargo period for requesting reconsideration available on request.

Additional changes to the CDR submission guidelines include:

  • revised guidelines for pharmacoeconomic submissions
  • Letter of Undertaking required for drugs receiving a Notice of Compliance with Conditions (NOC/c)
  • clarification of “current pricing”.

Revisions to the Procedure for Common Drug Review

Changes have been made throughout the Procedure for Common Drug Review and the formatting has been modified. The following outline lists the major revisions, in the order they appear in the document:

  • clarification – CDR can undertake only one kind of review of a submission at the same time (Section 1.1)
  • clarification – eligible submissions from manufacturers (definitions of new drug and new combinations revised, and clarification provided that any agent that is potentially funded by any of the participating drug plans is eligible for submission to CDR) (Section 1.1.2)
  • clarification – eligible resubmissions (definition of “new information” clarified) (Section 1.1.5)
  • addition – procedures for handling withdrawals (due to loss of market authorization or due to voluntary withdrawal) (Section 1.2)
  • addition – procedure for handling temporary suspension of a review (Section 1.3)
  • addition – resubmission procedures (including increased timeframe, to 10 business days, for CDR Directorate to determine if resubmission contains “new information” and is complete) (Section 3)
  • change – Reviewers’ reports sent only to manufacturer for comments (no longer sent to ACP/drug plans for information during this phase of the process) (Section 5.1)
  • change – increase in number of pages allowed for manufacturers’ comments on clinical and pharmacoeconomic reports (to six pages total) (Section 5.2)
  • addition – final version of CDR reviewers’ reports sent to manufacturer for information (at the same time as the confidential initial CEDAC recommendation and reasons for recommendation) (Section 5.4)
  • addition – description of CDR process for requesting permission to use confidential unpublished information in the CEDAC reasons for recommendation (Section 6.2.2)
  • change – extension to embargo period for requesting reconsideration (20 business days may be requested in addition to the usual 10 business days, providing a total of 30 business days to submit a request for reconsideration) (Section 6.4.1).

Revisions to Common Drug Review Submission Guidelines for Manufacturers

The revisions to the Common Drug Review Submission Guidelines for Manufacturers are widespread and include the reorganization of contents. Users are therefore encouraged to review the whole document when filing a submission or resubmission.

Some highlights include:

  • clarifications
    • CDR can undertake only one kind of review of a submission at the same time (Section 4
    • eligible submissions from manufacturers (definitions of new drug and new combinations revised, and clarification provided that any agent that is potentially funded by any of the participating drug plans is eligible for submission to CDR) (Section 4.1.2)
  • changes to the Category 1 requirements (Section 4.2.1)
    • cover letter
      • names of the primary and back-up contacts that CDR can contact about the submission must be supplied
      • clarification of the “current price” submitted
    • Notice of Compliance with Conditions (NOC/c) – Letter of Undertaking is required when a drug that has received NOC/c is submitted
    • efficacy, effectiveness and safety evidence – clarification that when submitting the Clinical Summary from the Common Technical Document, Modules 2.7.1, 2.7.3, 2.7.4 and 2.7.6 are required
    • table listing all completed and ongoing Canadian and international unpublished studies
      • the “Study Title and/or Description” column, the duration of treatment is required
      • a column has been added for listing abstracts and any publications related to unpublished studies (e.g., published reports on interim findings)
    • economic and epidemiologic information
      • Appendix 12 has been added to provide guidance on the types of economic analyses to submit
      • clarification that budget impact analyses must be provided as a Category 1 requirement, if a request for priority review is based on cost savings
    • bibliography and search strategies – only the search strategy and not the results is required
    • template table and letters may be found in Appendices 8, 9, 10 and 11
    • letter confirming ability to supply has been modified to indicate that the manufacturer must be able to meet demand for the product at the time the submission is filed
  • changes to the Category 2 requirements (Section 4.2.2)
    • requirement to provide Pharmaceutical Advertising Advisory Board approved promotional materials – if the manufacturer requests to waive this requirement, an indication of the timeframe is required (e.g. there will be no promotion of the product for one year)
  • changes to the Additional Information requirements (Section 4.2.3)
    • the manufacturer has the responsibility of advising the CDR Directorate of all data on harm related to the drug under review, including new data that arises during the review process
  • changes to the Resubmission requirements (Section 5.1)
    • clarification – eligible resubmissions (definition of “new information” clarified) (Section 5.1.)
    • number of copies to supply to CDR Directorate (Section 5.1.3)
    • changes to the Resubmission Requirements (Section 5.2):
      • guidance for filing resubmissions when withdrawn market authorization is reinstated, or following voluntary withdrawal
      • signed cover letter – names of the primary and back-up contacts who CDR can contact about the Resubmission must be supplied
      • product monograph (most recent) required
      • Drug Notification Form – a completed, dated and signed copy of the most recent form is required
      • Letter Authorizing Unrestricted Sharing of Information is required
  • Appendix 1 updated – when forwarding submissions to BC, Alberta and Ontario, the need for any different requirements should be checked on their web sites
  • Appendix 6 – pages in the submission should be numbered consecutively from the beginning to the end of the document, or numbered consecutively within clearly labeled sections
  • Appendix 7 – expanded to include a checklist for resubmissions
  • Appendix 12 – added to provide guidance on types of economic analyses to submit.