Ann: TGA Registration Update, page-63

there needs to be an official investigation of the TGA covid 19 test response. Home use products typically are put under higher scrutiny than tests designed for professional use (POC). Certainly is the case in US and EU. The TGA appears to take the opposite approach. We haven’t seen any recent clinical data from ADO but based on previous claims the Eugeni product is at least as good as that claimed by the Chinese and Korean products that have been approved by the TGA for home use. My question is why haven’t these imported products been required to conduct clinical studies at Australian institutes. If Eugeni was applying for approval in China they would be required to conduct studies in China and provide all aspects of manufacturer and reagents. It takes 2-3 years to get approval, if ever.
Why aren’t we requiring similar studies and disclosures of the Chinese products? There is definitely something not right with the current situation. And it smells very political.