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.
Regards
Deven
devensandhu@gmail.com
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Devender Sandhu
Director
Thornhill ON
Canada
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