Sponsor Engagement in the Drug Review Process
The Ministry has initiated an enhanced drug review process. An added attribute of the new process is the opportunity for sponsor engagement at four (4) separate stages of the drug review process.
Upon receipt of a drug submission, the Ministry will provide the sponsor with the following points of engagement:
Larger version of sponsor engagement diagram (opens in a new window)
The sponsor may review the reports of the Drug Review Resource Teams (DRRT) and submit written DRRT report comments to the Ministry within ten (10) business days of receiving the reports. These comments will be included in the documentation forwarded to the DBC for review. The comments should
New clinical evidence included in Manufacturer comments will not be considered by the DBC. If the manufacturer would like new clinical evidence considered by the DBC, the Manufacturer will need to resubmit the drug submission to the Common Drug Review (CDR) for a CDR submission or to the Ministry for a non-CDR submission.
The sharing of the embargoed DBC Recommendation and Reasons for Recommendation is intended to improve the dialogue between the Ministry and the sponsor. The sponsor will be provided with an embargoed copy of the DBC Recommendation & Reasons for Recommendation after the DBC meeting subject to requirements of a confidentiality agreement.
At the time the embargoed DBC recommendation is released, the sponsor may file a Request for Reconsideration based on grounds that either:
This written request, directed to the Director of Formulary Management, must be filed within five (5) business days of receiving the embargoed copy of the DBC Recommendation and Reasons for Recommendation.
The request for Reconsideration will comprise the reason and grounds for the request, the relief sought, and supporting evidence. A Request for Reconsideration cannot be made solely because the sponsor disagrees with the Recommendation. The Request must identify the aspect(s) of the DBC Recommendation with which the sponsor disagrees.
No new information will be considered in the reconsideration as new information requires a resubmission.
Requests are examined by the Ministry DBC Secretariat in consultation with the DBC Chair to determine whether the issue(s) raised can be resolved in discussions with the sponsor. If the Ministry is unable to address the issues, then the Request will be forwarded to the DBC for reconsideration.
If the Ministry does not receive a request for reconsideration after five (5) business days, the embargoed Recommendation and Reasons for Recommendation will become final.
Once a DBC Recommendation and Reasons for Recommendation document is made final, a sponsor may engage the Ministry within ten (10) business days of this final document being issued by submitting a written statement to firstname.lastname@example.org to request a meeting with the Ministry before the listing decision and its implementation occurs.
The Ministry, at its discretion, may also initiate discussions with the sponsor.
If and when discussions are initiated, the target time frame to complete discussions is within 25 business days after the final DBC Recommendation is released. The target timeline may be adjusted upon mutual agreement.
The sponsor may file a resubmission if new information becomes available that addresses the reasons for the decision. The resubmission should be made to the Common Drug Review (CDR) process for CDR drug submissions.
For non-CDR drug submissions, the Ministry has the discretion to determine whether the drug review reports will be made publicly available (i.e. posted on the Ministry website) once a listing decision has been made. Prior to posting publicly the submission sponsor will have 15 business days to review the final reports to request the non-disclosure of any specific portions that it deems to be of a confidential or proprietary nature. The time frame may be adjusted on mutual agreement.
If the submission sponsor requests the confidential information be deleted, the Ministry will remove the confidential information by using “blacking out” redaction techniques.