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Importing Drug/Device Product into Australia for Phase 1 Study

  • 1.  Importing Drug/Device Product into Australia for Phase 1 Study

    This message was posted by a user wishing to remain anonymous
    Posted 22-Apr-2021 08:59
    This message was posted by a user wishing to remain anonymous

    Hello RegEx Community,

    For a combination device containing drug product (monoclonal antibody) that is filled/finished in the US and being shipped to Australia for a Phase 1 clinical trial, what regulatory requirements must be addressed? Is their guidance from the TGA that may be of insight for this topic? Also of interest would be anything that may impact ethics committee approvals.

    Thanks so much!


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