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Canada clinical trial record retention period reduced from 25 to 15 years

  • 1.  Canada clinical trial record retention period reduced from 25 to 15 years

    Posted 02-Mar-2022 18:35
    Hi folks, 

    Health Canada announced that on February 27, 2022, the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations came into force. This was mostly an extension of previous interim orders relating to development of Covid products, with minor clarifications. 

    BUT! In addition, the Regulations include changes to:

    • Reduce the records retention period for all clinical trials of drugs and natural health products from 25 years to 15 years to improve alignment with international regulatory partners and to replace the temporary records retention period for drugs clinical trials with a 15 year period
    (emphasis mine)

    The policy announcement concluded with the following from Health Canada:

    Please accept our appreciation for the work you are doing. We look forward to working together with the intent of finding safe and effective treatment options to improve the lives of Canadians, including those affected by COVID-19.

    Depending on how your day is going, I thought some of you might need to hear that :) 
    Take care,
    Karen

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    Karen Long RAC
    Vancouver BC
    Canada
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