Regulatory Open Forum

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  • 1.  Canadian DMF Submission for CTA and DIN

    Posted 25-Sep-2020 09:04
    Hi RegEx member,

    I have an inquiry on the regulatory requirement for filing DMF Type I with HC:


    • Does all the information submitted in the DMF mandatory to be obtained from GMP materials including the complete validation of all the process and equipment?
    • Does the stability data included in the DMF require to be manufactured from a GMP batch (would a GPP batch be acceptable to present the data)?
    Thank you
    --
    Regards,

    Lynne Liu, MEng


  • 2.  RE: Canadian DMF Submission for CTA and DIN

    Posted 26-Sep-2020 07:48

    Hi Liu,

    I hope this helps.



    ------------------------------
    Sravan, PharmD
    Officer, Regulatory Affairs
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    Original Message


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