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  • 1.  Submission Classification: Types and Subtypes

    Posted 07-Oct-2022 14:21
    Hi,

    I am structuring the RIM system in my company, and I need more clarification in the submission classification for external US and Rest of the World applications. Is there any document available with a list of submission types and subtypes for different types of applications? Thanks in advance.

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    Silvia LeBlanc
    Fort Collins CO
    United States
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  • 2.  RE: Submission Classification: Types and Subtypes

    Posted 13-Oct-2022 12:03
    Hi Silvia

    No, considering the huge variety of regulated products and the many jurisdictions regulating them, I doubt anyone has compiled a comprehensive point-in-time list. You may need to do the research for your company's specific product types in the relevant countries.

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    Anne LeBlanc
    United States
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  • 3.  RE: Submission Classification: Types and Subtypes

    Posted 6 days ago
    The approach we have taken is to define the specific types in major markets (US, EU, Japan) but then fall back on generic descriptions like "major variation", "minor variation" with additional qualifiers like "do-and-tell" to communicate the basic requirements. As Anne said, there are just too many possibilities if you consider all possible markets.

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    Rachel Thornton
    Associate Director
    Smyrna GA
    United States
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  • 4.  RE: Submission Classification: Types and Subtypes

    Posted yesterday
    Hello Silvia,

    There is a MAPP for NDAs regrading NDA Classification Codes if that is what you are asking.
    https://www.fda.gov/media/94381/download.

    Regards,
    Ken

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    Ken Rose
    Painesville OH
    United States
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