Hi BabbaThere is a difference between the FDA and EMA (TGA is...

Hi Babba

There is a difference between the FDA and EMA (TGA is harmonized most closely to the EMA) in terms of approval process. They do however share information when appropriate and there is increasing harmonization where it is structurally similar.

https://pharmanewsintel.com/features/regulating-and-authorizing-medicines-a-comparison-of-the-fda-and-ema
https://www.sciencedirect.com/science/article/pii/S2452302X16300638

Some device and drug companies will have a split strategy and apply in the EU or Aus and then use data from approved products to apply to the FDA.
PAR has gone for a multicentre approach and is Targeting USA as a key first market. This does risk any failure being in multiple jurisdictions. It is also more cash draining.