We have the TGA (Therapeutic Goods Administration). They have...

We have the TGA (Therapeutic Goods Administration). They have approved a number of drugs over the years that have not been approved in USA.
The companies then have difficulty marketing to Australian doctors who are skeptical of a product that has not been FDA approved.

Recell spray-on skin was approved for years in Australia before getting approved in the USA. Extensively used in Western Australia where it was developed, but not accepted by the east coast of Australia. Approved in other countries as well, but difficult to get sales. NICE (England) could not recommend as stating not enough supporting evidence.

TGA could approve, but it doesn't mean that Australian doctors will use it.

Also, there is the issue of who will pay. In Australia we have free public health care that is funded by the taxpayer under the control of our governments. Are they willing to pay and how much are they willing to pay? The advantage of approval by the FDA is that USA sets the price of the product and, with the insurance system over there, are more willing to pay higher prices. Hence the FDA has control over drug approvals (considered the gold standard is bs. It's all about the money). It all boils down to who will give the best profits to the company.