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  • 1.  Health Canada MDL Approval Times

    Posted 28-Jul-2020 21:00
    Hello All,

    Can anyone provide feedback regarding current Health Canada Class II MDL approval timelines in recent months? We submitted a Class II MDL application on July 7, and I am trying to determine a realistic approval ETA. I know that they are prioritizing COVID-19 applications (which ours is not), so I thought I would poll the forum to see what other members' experiences have been.

    Thanks,
    Julia

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    Julia Brown
    Sr Manager, Regulatory Affairs
    Brisbane CA
    United States
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  • 2.  RE: Health Canada MDL Approval Times

    Posted 29-Jul-2020 03:05
    Hi Julia,

    There was a thread about this topic a few weeks back on the throughput times of MDL with Health Canada.  I have not doing any applications since virus episode started, so I could not comment on the current acceptance time of Class II applications, though can imagine like everything else around the world this has slowed significantly due to people out of work, priorities, etc.  In regular times, the applications went through in just a few weeks, usually less than 2 months as short as 2 to 3 weeks.  I would imagine you might be looking at the longer side of timeline now.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: Health Canada MDL Approval Times

    Posted 29-Jul-2020 14:26
    My experience has been similar - in normal times, the turnaround for Class II MDLs, turnaround is 2 months or less, often about 3 weeks.

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    Hiral Dutia
    Sr. Regulatory Affairs Specialist
    Third Pole Therapeutics
    Waltham, MA
    USA
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    Original Message


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