Consultation on the Pause the Clock proposal for pre-market submissions and applications
From: Health Canada
Current status: Closed
We want your feedback on the development and implementation of the Pause the Clock mechanism for pre-market submissions and applications.
A Pause the Clock mechanism would enable us to grant extensions for drug submissions and applications without being penalized for extended review times. It would also enable us to pause the clock when we seek advice from an expert panel/committee as it relates to a drug being reviewed. For medical devices, it would allow us to pause the clock if there are applications that are linked together that have different review times.
We review drug and medical device applications within set timelines. Timelines are defined based on the type and class of a submission or application. Within set timelines, we assume that the review process would not include:
- sponsor requests for extensions
- advice from an expert advisory panel/committee
- or linked applications
We are proposing to implement a mechanism to pause the clock under these specific circumstances. This way, we are only accountable for the time we spend on a particular submission/application.
We are seeking the views of:
- stakeholders from industries including:
- medical devices
- generic drugs
- new drugs
- biologic drugs
- over-the-counter (non-prescription drugs)
- radiopharmaceutical drugs
- veterinary drugs
- others who are interested
We are interested in stakeholder feedback on the following questions:
- What are your thoughts on the proposed triggers listed in our proposal? Please provide specific feedback on the proposed triggers.
- Can you think of a situation in the review process beyond those mentioned within our proposal where a trigger could be used?
- When would it be valuable from industry's point of view to be able to pause the clock? Please describe under what circumstances this would occur.
When and where
Feedback on the public consultation on the proposal will be collected between August 10, 2018 and October 9, 2018.
How to participate
- Read our Proposal: Pause the Clock Proposal for Pre-market Submissions/Applications
- Use the template to format your responses
- Provide your comments by email to firstname.lastname@example.org
Office of Policy and International Collaboration
Biologics and Genetic Therapies Directorate
Address Locator 0601B, Tunney's Pasture
100 Eglantine Driveway, Ottawa, Ontario
Report a problem or mistake on this page
- Date modified: