Changes, Updates and Reminders Related to CDR Guidelines
On Friday, June 9th, CADTH issued a CDR Update with a number of changes, updates, and reminders that are worth reviewing. The key highlights are:
- Two Process Changes
- Guidance for Subsequent Entry Non-Biological Complex Drugs
- Revised Documentation for Resubmissions
- Two Reminders (In-person CDR Meetings/Confidential Prices)
- Communication with Consultants
Further detail, which has been drawn from the CDR Update, can be found below.
Two Process Changes
- Revised Advanced Notification Process for CADTH Common Drug Review for Drugs Undergoing Expedited Health Canada Review
Effective immediately, CADTH is reducing the mandatory advance notification requirement for drugs that are undergoing review through Health Canada’s expedited review pathways from 120 calendar days to 30 business days. Important Note: This change is effectively immediately and is only applicable for submissions being filed through the CDR process. The advanced notification process for the pCODR process remains unchanged.
- Revised Date for Confirmation of Anticipated Filing Date
This revision introduces the following efficiencies:
- Provides clarity regarding the required timing of confirmation by setting a clear target in business days
- Provides separation of the timing for confirming the date of filing and the timing for posting patient group input.
Previous Confirmation Procedure
- A manufacturer is required to advise CDR by email (email@example.com) of changes in the anticipated date of filing a submission or resubmission as soon as possible, and to similarly confirm the anticipated date of filing the complete submission or resubmission one month in advance.
Revised Confirmation Procedure
- A manufacturer is required to advise CDR by email (firstname.lastname@example.org) of changes in the anticipated date of filing a submission or resubmission as soon as possible, and to similarly confirm the anticipated date of filing the complete submission or resubmission 30 business days in advance.
Guidance for Subsequent Entry Non-biological Complex Drugs
Submissions for subsequent entry non-biological complex drugs will undergo a tailored CDR review. CADTH currently follows a tailored review process for all CDR submissions involving new combination products (funded components) and for biosimilars. Submissions for subsequent entry non-biological complex products may be filed on a pre-NOC or post-NOC basis using the current processes described in section 2.2 of the Procedure for the CADTH Common Drug Review (August 2014).
The template for the subsequent entry non-biological complex drugs can be found here, and the submission requirements will follow the requirements outlined for the biosimilars in section 5.1.3 of the Submission Guidelines for the CADTH Common Drug Review (August 2014). Subsequent entry non-biological complex drugs will follow schedule C of the application fee schedule. All manufacturers should contact CADTH before filing a CDR submission for a subsequent entry non-biological complex drug (email@example.com).
Revised Documentation for CDR Resubmissions
Effective immediately, the Number of Patients Accessing New Drug document is no longer a category 1 requirement for resubmissions. The CDR Update summarizes the revised section the Submission Guidelines for the CADTH Common Drug Review. The Number of Patients Accessing New Drug template on the CADTH website has been updated to reflect this change. Applicants currently preparing resubmissions should follow the new requirements.
- In-Person Meetings Regarding CDR Submissions
Due to the volume of requests and the need to optimally utilize limited resources, CADTH is unable to offer in-person meetings to manufacturers who have questions regarding the CDR process, and encourages manufacturers who have questions regarding the CDR process to submit a written inquiry to firstname.lastname@example.org and a written response will be provided in a timely manner.
- Confidential Prices Are Not Accepted in CADTH’s CDR and pCODR Processes
CADTH would like to remind manufacturers that confidential prices are not permitted in submissions and resubmissions filed for review through the CDR and pCODR processes. The submitted price will be disclosed in all applicable CDR and pCODR review reports, as well as CDEC and pCODR Expert Review Committee (pERC) recommendation documents posted on the CADTH website.
Communication with Consultants
Consultants working on a CDR submission or resubmission on behalf of a manufacturer are advised to copy an official contact for the manufacturer on all email correspondence with CADTH. CADTH will not respond to any email correspondence from a consultant if an official contact for the manufacturer has not been copied.
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