Posted by Michael Wonder on 17 Aug 2018
Health Canada proposes ‘pause the clock’ mechanism for pre-market submissions
15 August 2018 - 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.
