On June 9, 2017, the Canadian Agency for Drugs and Technologies in Health (CADTH) released a new CDR Update (Issue 122) describing the following changes.
1. Revised Advanced Notification Process for CADTH Common Drug Review
Drugs Undergoing Expedited Health Canada Review
Effective immediately, the mandatory advance notification requirement for drugs that are undergoing review through Health Canada’s expedited review pathways (i.e., priority review or Notice of Compliance with Conditions [NOC/c] at the outset) has been reduced from 120 calendar days to 30 business days. The revised notification process will apply to submissions that are filed on either a pre-Notice of Compliance (NOC) or post-NOC basis. This change is only applicable for submissions being filed through the CDR process. The advanced notification process for the pCODR process remains unchanged. In order to be eligible for this revised process, the drug must have been accepted for review by Health Canada on or after June 1, 2016. For details of the revised process, please consult the following document: Revised advance notification process for pending CDR submissions.
As a result of this revision, the advance notification forms have been updated to allow manufacturers to identify whether or not the pending submission is for a drug that has received a priority review designation from Health Canada or has been accepted for review for a NOC/c at the outset. All manufacturers are requested to use the following updated form: CADTH Pre-Submission Information Requirements Form for a Submission.
Revised Date for Confirmation of Anticipated Filing Date
A manufacturer is required to advise CDR by e-mail (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 30 business days (as opposed to one month) in advance.
2. Subsequent Entry Products for Non-biological Complex Drugs
CADTH, in consultation with CDR-participating drug plans, has determined that subsequent entry non-biological complex drugs are eligible for review through the CDR process. Submissions for these products 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. 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 (firstname.lastname@example.org).
3. 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 template on the CADTH website has been updated to reflect this change. Applicants currently preparing resubmissions should follow the new requirements.
4. Reminder: In-Person Meetings Regarding CDR Submissions
CADTH has recently been receiving an increasing volume of requests for in-person meetings, in addition to the aforementioned pre-submission meetings that are offered, to discuss inquiries related to the CDR process. 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 email@example.com.
5. Reminder: Confidential Prices Are Not Accepted in CADTH’s CDR and pCODR Processes
This is a reminder to 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. This procedure came into effect on April 1, 2016.
6. 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 e-mail correspondence with CADTH. CADTH will not respond to any e-mail correspondence from a consultant if an official contact for the manufacturer has not been copied.
For further information, please refer to the CADTH website.