Health Canada Proposes ‘Pause the Clock’ Mechanism for Premarket Submissions
Health Canada recently released for consultation a plan to establish a mechanism that allows for the review clock on premarket submissions to be formally paused.“A pause the clock policy will be implemented in parallel with the new user fees for drugs and medical devices, by April 2019,” Health Canada said.
The consultation, which is part of the user fee proposal, seeks to pause the review clock during a review only when pre-specified conditions (triggers) are met. The consultation seeks feedback on what those triggers should be.
“Within the proposed model, it is anticipated that clock pauses would be triggered only under defined circumstances; therefore would not routinely add to the total time to decision,” Health Canada said. “In some circumstances, a pause could avoid the submission receiving a negative decision (i.e. a pause the clock could avoid the need for a submission/application to receive a Notice of Non-compliance, such as when the sponsor is unable to respond to a clarifax within 15 days).”
On the pharmaceuticals side, Health Canada proposes a pause “when there is Health Canada approval of a sponsor’s request for an extension to a clarification or Minor Information Request beyond the number of days that they have to respond in accordance with applicable guidance documents.”
Another trigger that could apply under this mechanism would be when Health Canada determines the need to use an expert advisory panel/committee.
On the device end, Health Canada proposes, among other provisions, using a trigger when the review of one device application is complete except that the review of an additional device application it is linked to remains outstanding.
Feedback on the consultation will be collected until 9 October.
Health Canada