Regulatory Open Forum

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  • 1.  Phase 1 Clinical Trials

    Posted 04-Mar-2023 06:39
    Can anyone guide if Health Canada requires a GMO certificate for a Phase 1 clinical submission?

    Thank you


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  • 2.  RE: Phase 1 Clinical Trials

    Posted 06-Mar-2023 18:28

    Hi Meena,

    HC does not generally require GMP certificates.



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    Glen Park PharmD
    Vice President, Regulatory Affairs and Quality Assurance
    New York NY
    United States
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    Original Message


  • 3.  RE: Phase 1 Clinical Trials

    Posted 06-Mar-2023 20:40

    I don't think that OP asked about GMP rather GMO certificate. Please correct me if my assumption is incorrect!  Yes, in my experience we have supplied GMO for all the excipients used in a drug product! I am not sure if this is a requirement from a Canadian regulatory perspective! Others please provide input!



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    GRSAOnline
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    Original Message


  • 4.  RE: Phase 1 Clinical Trials

    Posted 07-Mar-2023 07:11
    Thank you for your replies.. The question is for GMO ( not GMP) certificates. 
    Are these equivalent to Animal Origin Certificates for raw materials but specific for CGT products?



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  • 5.  RE: Phase 1 Clinical Trials

    This message was posted by a user wishing to remain anonymous
    Posted 07-Mar-2023 08:46
    This message was posted by a user wishing to remain anonymous

    Drugs or biologics?


    Original Message


  • 6.  RE: Phase 1 Clinical Trials

    Posted 07-Mar-2023 08:58
    Biologics

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  • 7.  RE: Phase 1 Clinical Trials

    This message was posted by a user wishing to remain anonymous
    Posted 07-Mar-2023 09:52
    This message was posted by a user wishing to remain anonymous

    Not equivalent to Animal Origin certificates! GMO is different!


    Original Message


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