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Non-clinical ADA validation for NMPA IND submission

  • 1.  Non-clinical ADA validation for NMPA IND submission

    Posted 15 days ago

    Hi All,

    We will conduct a GLP-tox study outside of China but IND is planned to be submitted to NMPA as well. I would follow a lean approach for ADA testing if it was submitted to the FDA/EMA , however, the NMPA CDE guideline calls for multi-tier testing, validation of such a method and moreover, duplicate analysis. Based on the feedback from some of the larger Chinese CROs, validation of the screening and confirmatory tiers are mandatory and the confirmatory has never been waived.

    Do you have experience with accepted leaner approaches for NMPA IND submission, e.g. no validation and running non-GLP ADA analysis or validation of the screening tier only and running single-tier analysis under GLP, singlicate analysis?

    Thanks,

    Szilard



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    Szilard Kamondi
    Bioanalytical Consultant
    Switzerland
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