That should have been a stipulation prior to the submission as there were other variants already out there already when they submitted . As others have stated , if that's the new criteria , those in market should also have to submit and publicise efficacy. If it had the name Shizer or big pharma next to it ...straight through.
Poor but not unexpected as posted previously...more hurdles for the little battler.
Where will the next goalposts be?
Ann: TGA Registration Update, page-23
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