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China US MRA or testing requirements for clinical supplies in China clinical study

  • 1.  China US MRA or testing requirements for clinical supplies in China clinical study

    This message was posted by a user wishing to remain anonymous
    Posted 08-26-2023 13:49
    This message was posted by a user wishing to remain anonymous

    Dear Colleagues,

    Is there a mutual recognition agreement (MRA) between US and China for biologics (mAbs) clinical supplies testing? 

    For a clinical supply batch (CTM) of investigational biologic (IMP) in China clinical study:  if a QC release test (e.g. assay/purity) is performed at a US/EU testing site, is it a China regulatory/QC requirement that the test be repeated at a China QC testing site for the batch/lot to be acceptable for use in the China clinical study?

    To clarify, I am not asking about the requirement for China NMPA Lab which does its own verification testing.

    Thanks in advance