The EMA and FDA like to play leapfrog with their regulations with ever increasing paperwork requirements. The EMA upped their paperwork requirements in 2020 so they currently have the most stringent standards. Any drug that meets EMA cGMP regulations also meets FDA cGMP standards - of course until the FDA ups their requirements again.
The TGA has the least stringent paperwork requirements and you can use a new drug in Australia even if it doesn't meet the full EMA?FDA cGMP requirement (i.e. you can use it in patients if it is cGMP-like). This is one of the reasons Australia is such a good place to do Phase 1 trials.
The bottom line is by manufacturing RC220 in the EU to EMA cGMP standards we will have a drug that we can use in patients anywhere in the world.
IND before Australian ethics?, page-12
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