Health Canada Asks for Feedback on ‘Pause the Clock’ Proposal for Premarket Submissions

Health Canada is seeking feedback on its plan to “pause the clock” during drug reviews without penalizing sponsors for extended review times.

The mechanism would help sponsors meet review deadlines and to clarify any issues that arise without penalties. Under the plan, the department would also be able to pause the clock when it seeks advice from expert panels during reviews.

The agency called for comments by Oct. 9 from stakeholders in industries including generics, biologics, new drugs, radiopharmaceuticals and OTC drugs.