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  • 1.  China - Supporting documents for "legal origin" of API, excipients

    Posted 28-Jan-2021 14:34
    Hello,
    The Chinese Guidance for CTD Module 1, request "Supporting documents for legal origin of active pharmaceutical ingredients, pharmaceutical excipients and pharmaceutical packaging materials,, including supply agreements and invoices, etc."
    While I am preparing a large submission for one of my clients, some of the suppliers refuse to share agreements or invoices as these are considered commercially confidential and proprietary information. 
    I wanted to know if any of you have faced the same issue and have found ways around it, which were accepted by CDE?
    Thank you in advance.
    Iris

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    Iris Meisner
    RA Consultant
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  • 2.  RE: China - Supporting documents for "legal origin" of API, excipients

    Posted 29-Jan-2021 20:41
    Hello,

    As this might be a very tedious request and time consuming work, there is definitely a push back for requesting API, excipients, and CC invoices. However, per my experience with one American and one European CMOs, changes were made to the existing contract with additional fees and invoices were provided. 

    Hope it helps.
    BR

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    Negin Dameshghi Seisan
    CMC Regulatory Affair Manager
    Bethesda MD
    United States
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    Original Message


  • 3.  RE: China - Supporting documents for "legal origin" of API, excipients

    Posted 30-Jan-2021 12:02

    Dear Negin,
    thank you for your kind answer.
    Iris



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    Iris Meisner
    Zichron Yaakov
    Israel
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    Original Message


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