Yep remdesivir was pretty much approved by TGA based on the regulatory approval in Europe. We copy the other regulators.
Regulatory status
This product is considered a new chemical entity for Australian regulatory purposes.
At the time the TGA considered this application, a similar application had been approved
in Japan, Singapore and the European Union (EU), and was under consideration in the
United States of America (USA) and Canada (see Table 1).
On 3 July 2020, the European Commission granted a conditional marketing
authorisation;16 for remdesivir, for the treatment of COVID-19 in adults and adolescents
from 12 years of age (weighing at least 40 kg) with pneumonia who require supplemental
oxygen.
Cell Therapy News/Articles, page-5435
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