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  • 1.  API Manufacturer Change Notification to Client/Sponsor

    Posted 15 days ago

    I am the only RA person at an API manufacturer and found previous person in role set up a system of "commitments" where they tracked all documents shared with clients that may be used in regulatory filings. There is a change notification process in place as well but this is built on top of it.

    My question is, if clients/sponsors are submitting complete documents in regulatory filings (INDs, NDAs) are they required to keep them updated in annual reports or notifications? Our regular change control/notification process (which are captured in document revisions anyways) seems more than sufficient, rather than having to notify them every time we make a revision.

    I don't recall having to worry about doc revisions on med device side for FDA or EU. The assessment was always about the change itself. A revision to a document alone didn't trigger a notification. For example, if there's admin changes, or a revision that doesn't affect safety, quality, performance of product.

    I'd like to remove this commitments tracker and stick to change control/notification system but want to make sure I am not missing something.



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    J. Fox JD
    Senior Regulatory Specialist
    EVERSANA Life Science Services
    Arvada CO
    United States
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  • 2.  RE: API Manufacturer Change Notification to Client/Sponsor

    Posted 12 days ago

    Sponsors of INDs/NDAs are required to amend their applications when required depending on the significance of the changes. Minor administrative, formatting, grammatical changes do not require amendment of the application.  There's a guidance document for post approval changes for NDAs - Changes-to-an-Approved-NDA-or-ANDA. It's common for sponsors to provide a copy of the Mod 3 CMC sections that they've submitted to their drug substance and drug product manufacturer so the manufacturers know what was committed to by the sponsor. Yes - your change control process should include a requirement that the sponsor provide a regulatory assessment for any change you are making and whether it impacts their IND/NDA submission.



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    Tom Stothoff
    Senior Director, Regulatory Affairs CMC
    Chicago
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    Original Message


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