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Australia Vaccine Phase 1 submission

  • 1.  Australia Vaccine Phase 1 submission

    Posted 27-Jul-2023 11:56

    Question with Reference to Vaccine trial approval in Australia. It is believed that in Australia, Therapeutic Goods Administration (TGA) only requires IB and Protocol for approval of Clinical Phase trial I. There is no IND and IMPD files required as compared to FDA, EU or UK submissions. If this is indeed true then how CMC information ( Quality, COA, COC, Viral clearance results, Stability info) for the manufactured GMP lot is reviewed by the TGA ( Australian Regulatory Agency). 

    If anybody has experience in IB submission/write up including CMC submission  for Vaccine w TGA, then please contact me. 



    Devender Sandhu
    Thornhill ON