Regulatory Open Forum

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  • 1.  Type IV submissions

    Posted 09-Apr-2014 09:23
    Hi All,

    Do Type IV DMF's have to be submitted electronically? Or is paper general practice.

    With looking at guidances on the FDA website, it seems to only reference paper submissions for Type IVs.

     Anyone have any further experience/insight?

     

    Any and all feedback is greatly appreciated!

    With Gratitude,
    Kelsey

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    Kelsey Frisch
    Reliable Biopharmaceutical
    Overland MO
    United States
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  • 2.  RE:Type IV submissions

    Posted 10-Apr-2014 11:20
    Kelsey,

    There is no specific requirement to submit DMFs electronically.  However; if submitted electronically, then DMFs submitted in electronic format must have "(ESUB)" in the Subject field. I would offer that if your primary dossier is in electronic format then the DMF should also be in electronic format.  In the world of elecrtronic submission, it makes the cross-referencing and access to specific information in the DMFs easier.

    Dar

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    Darlene Rosario
    Principal Consultant RA, Quality and Compliance
    Velocity Consulting
    Ventura CA
    United States
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    Original Message


  • 3.  RE:Type IV submissions

    Posted 10-Apr-2014 12:29
    Dear Kesley,

    Any DMF can be submitted electronically. I have experience of filing Type V DMF as eCTD.

    Excerpt from FDA website: (http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/DrugMasterFilesDMFs/UCM2007046):-
    ---------------------------------------------
    ELECTRONIC     DMFs (Category 3)

    There is no requirement to file DMFs in electronic format.  Paper DMFs will continue to be accepted. 

    The FDA has published a Draft Guidance "Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (01/03/2013) regarding electronic submissions.  DMF holders are encouraged to submit their DMFs in electronic form, including updating current paper DMFs.  DMFs must be in ECTD format .

    ---------------------------------------------
    Here, we should observe that FDA has referred 'DMF'', which should be applicable for any DMF. 

    For further clarification, you can reach  CDER at esub@fda.hhs.gov or CBER at esubprep@cber.fda.gov. esub is very supportive for electronic submissions.

    Hope this helps.

    Regards,
    Shrivathsa


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    Shrivathsa Achar
    Manager
    Biocon Limited
    Bangalore
    India
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    Original Message