Notice - Reconsideration of Decisions Issued for Human Drug Submissions

April 1st

Notice

Our file number: 15-103791-905

Release of the revised: Guidance Document: Reconsideration of Decisions Issued for Human Drug Submissions

Health Canada is pleased to announce the release of the revised Guidance Document: Reconsideration of Decisions Issued for Human Drug Submissions.

This document is intended to describe the appropriate mechanisms to address drug submission-related disputes. It has been updated as part of Health Canada's Regulatory Transparency and Openness Framework to reflect a redesigned reconsideration process with increased transparency and impartiality.

A revised document was released for a 60-day consultation starting in August 2014. The 2015 version has been updated to reflect feedback from stakeholders.

The revised Guidance has been reorganized to improve flow and readability. It includes administrative changes to increase clarity in the roles and responsibilities for the management of the reconsideration process. Specifically, responsibility for the management and administration of the process is being transferred to the Food and Drugs Act Liaison Office (FDALO), located in the Communications and Public Affairs Branch of Health Canada. The Guidance Document clarifies when human drug submission decisions that are eligible for reconsideration become final. Another procedural improvement is the introduction of clear timelines for Review Bureaux to communicate with sponsors following a favourable reconsideration decision.

Based on feedback received in the consultation, Health Canada has maintained eligibility for reconsideration of the Priority Review Request under the Priority Review Policy and the Request for Advanced Consideration under the Notice of Compliance with Conditions Policy.

The Department will discontinue preparing the Summary Basis of Reconsideration Decisions (SBRD). The intent of the SBRD was to inform stakeholders of reconsideration decisions. This mechanism was very rarely used and difficult to prepare given the possible disclosure of confidential business information for a submission that has not yet received market authorization. Health Canada is committed to communicating regulatory decisions and policy changes to stakeholders and will use the most appropriate mechanisms (as identified by the individual Directorates) to do so, following the final decision. For applicable drugs, reconsideration decisions will continue to be described in Summary Basis of Decision and/or Regulatory Decision Summary documents as this process forms part of the rationale for a decision to issue market authorization.

The Department will discontinue using Scientific Advisory Committees (SAC) as a mechanism to resolve a dispute under reconsideration in specific drug submissions. SACs are intended to provide advice to Health Canada on pharmaceutical science and clinical pharmacology issues and meet infrequently, on an as needed basis.

This Guidance takes effect on April 1, 2015. FDALO will be responsible for the administration of all reconsideration processes initiated as of that date for the Therapeutics Products Directorate and Biologics and Genetic Therapies Directorate.

A summary of the consultation comments and how they were addressed can be obtained by contacting FDALO.

At this time, all reconsideration processes for non-prescription drugs regulated by the Natural and Non-Prescription Drugs Directorate (NNHPD) will carried out by that Directorate. FDALO, in conjunction with NNHPD, will carry out a review and revision of the reconsideration process for non-prescription drugs and natural health products in 2015-2016.

For More information:

Food and Drugs Act Liaison Office
200 Eglantine Driveway
Address Locator 1915C
Ottawa, Ontario
K1A 0K9

E-mail: fdalo@hc-sc.gc.ca
Telephone: 613-957-4284
Toll free: 1-866-339-4998
Facsimile: 613-946-3585
Teletypewriter: 1-800-465-7735 (Service Canada)