CDR Update - Issue 47

In This Issue

• Changes to the CDR Submission Guidelines for Manufacturers
• Changes to the Procedure for CDR

The Common Drug Review routinely reviews and revises its Submission Guidelines for Manufacturers and the Procedure for CDR as part of ongoing efforts to ensure that they are as current and clear as possible. Listed below are revisions to the two documents.

Changes to the CDR Submission Guidelines for Manufacturers

Section 4.1.2 Eligible Submissions from Manufacturers

• Clarification of the description of line extensions

Section 4.1.4 Screening of Submission for Completeness; Required Number of Copies, and
4.2.2 Category 2 Requirements

• Change: only one complete set of Category 2 Requirements is required by the CDR Directorate. No additional copies of the Category 2 Requirements need to be sent to the CDR after they are deemed complete.

Section 4.2.1 Category 1 Requirements

(a) Signed Cover Letter

• Change: manufacturers must indicate in the cover letter if they wish to have the copies of confidential submission information returned at the end of the review (at the manufacturer’s expense). Unless so advised, the CDR Directorate will destroy copies of confidential submission information by shredding and will retain one complete set of documents on file for as long as there may be a need to consult them.

(d) Product Monograph

• Clarification: the maximum number of pages for the Product Profile is three. (Note: each side of a page is counted as one page.)

(e) Efficacy, Effectiveness and Safety Evidence

• Change: a copy of the Clinical Overview (Module 2.5) and Clinical Summary (Modules 2.7.1; 2.7.3; 2.7.4; and 2.7.6), from Module 2 of the Common Technical Document, can now be provided in searchable PDF or Microsoft Word format on CD. (Note: A hard copy is still required.)
• Change: when submitted, the Clinical Studies section of the Comprehensive Summaries can now be provided in searchable PDF or Microsoft Word format on CD. (Note: A hard copy is still required.)
• Change: the tabulated list of studies included in the submission should include all Phase 3 studies mentioned in the Common Technical Document.
• Change: for submissions of drugs available on the Canadian or international market for 10 years or more, manufacturers should contact the CDR Directorate for guidance on which published and unpublished studies to include in the table of studies under the category “studies not included in the submission”.

Section 5.2 Resubmission Requirements

Table 2: Guidance for Filing Resubmission

• Clarification: what the manufacturer must submit to the CDR has been clarified for:
  • resubmissions filed after re-instatement of a previously withdrawn market authorization
  • resubmissions filed after voluntary withdrawal.

(a) Signed Cover Letter

• Change: manufacturers must indicate in the cover letter if they wish to have copies of confidential submission information returned at the end of the review (at the manufacturer’s expense). Unless so advised, the CDR Directorate will destroy copies of confidential submission information by shredding and will retain one complete set of documents on file for as long as there may be a need to consult them.

(d) Information about a Drug with Notice of Compliance with Conditions (NOC/c)

• Change: added requirement that manufacturers are to provide the status of confirmatory studies listed in the Letter of Undertaking and to provide the most recent interim analysis results for the confirmatory studies.

Appendix 1 Participating Federal, Provincial, and Territorial Drug Plans

• Change: updated contact information for Newfoundland and Labrador.
• Correction: mailing addresses for the Royal Canadian Mounted Police and the Correctional Service of Canada have been amended.

Appendix 5 Confidentiality Guidelines

• Change to Sections 6 and 7: description of archiving and disposal of confidential information. Unless the manufacturer indicates in the cover letter accompanying a submission or resubmission that copies of confidential documents are to be returned to the manufacturer for disposal, the CDR Directorate will destroy the copies by shredding. The CDR Directorate retains one complete set of documents on file, related to a submission or resubmission, for as long as there may be a need to consult them.

Appendix 7: Submission and Resubmission Checklists

• Change: checklists have been revised to reflect changes in submission and resubmission requirements.

Appendix 8: Table Template for Listing Canadian and International Published and Unpublished Studies

• Change: footnotes have been added to reflect changes described above for Section 4.2.1(e)

Changes to the Procedure for CDR

Section 1.1 General Information about the CDR Procedures

• Clarification: description of the exception for when a drug can undergo review as a submission and resubmission concurrently (i.e. when the basis for a resubmission is a new indication).

Section 1.2.1 Withdrawal of Market Authorization by Health Canada

• Clarification: a review of a submission or resubmission under this circumstance is stopped, not suspended.

Section 1.2.2 Voluntary Withdrawal of a Submission or Resubmission

• Clarification: this section has been rewritten to describe the procedure more clearly.

Section 8: Phase IV — Disposition of Submission and Resubmission Documents

• Change: this section has been added to describe the CDR procedures for disposition of documents after the completion of the CDR review of a submission or resubmission. This corresponds to the changes made in the Confidentiality Guidelines.

Appendix 3: Confidentiality Guidelines

• Change to Sections 6 and 7: a description of archiving and disposal of confidential information. Unless the manufacturer indicates in the cover letter accompanying a submission or resubmission that copies of confidential documents are to be returned to the manufacturer for disposal, the CDR Directorate will destroy the copies by shredding. The CDR Directorate retains one complete set of documents on file, related to a submission or resubmission, for as long as there may be a need to consult them.