Great post @ReillyBlue,
I am familiar with Notre Dame uni, we have a campus in Sydney as well & whilst a newer University, it will take time to build their credibility based on their research achievements. An example of this is UWS & Sydney University for a generalised comment on medical & nursing research. UWS I believe began their nursing courses in the 1980s & their Medical degree, far more recently. Ethics Approval IS through the Institutional Board.
Anyway thats as an aside for the reason of this post.
Here is information regarding TGA, how new/investigational medications are accessed during/post clinical trials if they are successful for special access as well. It’s a 109 page document, but I think page 09 (a flow chart) to 016 with more detailed information will be helpful.
https://www.tga.gov.au/sites/default/files/clinical-trials-guidelines.pdf
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