Therapeutic Goods Administration
The Therapeutic Goods Administration (TGA) is the Australian government authority responsible for evaluating, assessing, and monitoring therapeutic goods. It regulates medicines, medical devices, and biologicals to help Australians stay healthy and safe.www.tga.gov.au
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Search complete. 112 mentions across 42 episodes found for "Therapeutic Goods Administration".
Sep 9, 2026
speaker_1HOST
This development highlights the potential of CAR-T technology beyond hematologic cancers and indicates an intensified focus on pediatric oncology therapeutics.
speaker_1HOST
In regulatory news, Chianogi's Safedarical has gained approval from Australia's Therapeutic Goods Administration, TGA, for combating carbapenem-resistant gram-negative bacterial infections.
speaker_1HOST
Safedarical addresses critical needs in combating multidrug-resistant pathogens, particularly in urinary tract infections, and highlights ongoing global efforts to tackle antimicrobial resistance.
speaker_1HOST
Clinical trials continue to yield promising outcomes.
speaker_0HOST
John Staden is a scientific director at sunscreen testing lab SciePharm.
speaker_0HOST
He says it shows that the TGA lacks a good audit process on sunscreens.
John StadenSOUNDBITE_SPEAKER
And that audit process is one that should be applied to test labs before they're certified or otherwise accredited, particularly by a sponsor of a product or a manufacturer, uh, who offers to do that.
speaker_0HOST
Wild Child is also being sued by Advanced Skin Technology, owner of the high-end Aspect skincare brand, which recalled two products.
Leanne WardHOST
Basically, I just wanted to remind people that RETA is not actually considered safe in Australia because legally we are not allowed to prescribe it here at the moment.
Leanne WardHOST
So the TGA, which is the Therapeutic Goods Administration, and the Australian authorities have not actually made it safe for administration here in Australia yet.
Leanne WardHOST
So if you're in another country overseas, that may be different.
Leanne WardHOST
But in Australia, RETA is not actually approved or considered safe.
Emily KirkpatrickGUEST
It sounds like that.
Emily KirkpatrickGUEST
But I think it's helpful for people to know that if you are on side effects and you think these are new medications, so we want to hear about these side effects, that you can actually go online and log in your side effects in the Therapeutic Goods Administration website.
Emily KirkpatrickGUEST
That's the TGA website.
Emily KirkpatrickGUEST
You just type in TGA side effects into your web search browser and you can actually then say what your side effects are.
Emily KirkpatrickGUEST
It's anonymous reporting.
Emily KirkpatrickGUEST
You don't need to put your name in with it.
Emily KirkpatrickGUEST
You talk with your doctor, but also you can self-report these side effects into the website as well.
Graeme GoodingsHOST
And it's obviously important to go to a recognised website because, you know, we all talk about Dr Google and, you know, feeling symptoms of this and you type it in, you get some horrible results, but they're not necessarily attributed to anyone legitimate.
Emily KirkpatrickGUEST
It sounds like that.
Emily KirkpatrickGUEST
But I think it's helpful for people to know that if you are on side effects and you think, these are new medications, so we want to hear about these side effects, that you can actually go online and log in your side effects in the Therapeutic Goods Administration website.
Emily KirkpatrickGUEST
That's the TGA website.
Emily KirkpatrickGUEST
You just type in TGA side effects into your web search browser and you can actually then say what your side effects are.
Emily KirkpatrickGUEST
It's anonymous reporting.
Emily KirkpatrickGUEST
You don't need to put your name in with it.
Emily KirkpatrickGUEST
You talk with your doctor, but also you can self-report these side effects into the website as well.
Graeme GoodingsHOST
And it's obviously important to go to a recognised website because, you know, we all talk about Dr Google and, you know, feeling symptoms of this and you type it in, you get some horrible results, but they're not necessarily attributed to anyone legitimate.
Caleb RuncimanGUEST
That's right, Ben.
Caleb RuncimanGUEST
Operation Tempest is the latest operation involving the National Disruption Group, which led by the Australian Border Force with WA Police, WA Health, Therapeutic Goods Association.
Caleb RuncimanGUEST
staff inspect a number of businesses across WA.
Caleb RuncimanGUEST
Barber shops were some of those.
Caleb RuncimanGUEST
That's right, Ben.
Caleb RuncimanGUEST
Operation Tempus is the latest operation involving the National Disruption Group, which led by the Australian Border Force with WA Police, WA Health, Therapeutic Goods Association, staff inspect a number of businesses across WA.
Caleb RuncimanGUEST
Barber shops were some of those.
Caleb RuncimanGUEST
We had a barber shop in Perth and some down Margaret River Way and police and border force have identified people with links to the illicit trade kind of running those businesses.
DebbieHOST
The EU Medical Device Regulation, MDR, makes allowances for custom-made devices or emergency use.
DebbieHOST
And in Australia, the TGA, which is the Therapeutic Goods Administration, has a special access scheme, SAS, to import and supply unapproved therapeutic goods, including specialised medical devices, for single patients with serious or life-threatening illnesses.
DebbieHOST
So in those kind of rare disease examples.
DebbieHOST
In Japan, for example, they focus primarily on priority reviews and expedited approvals for often designated medical needs, but manage unapproved or rare need device access either through clinical trials or on a case-by-case basis for named individuals.
Tony NikolicGUEST
She helped me in the very first case that went to hearing here in Australia on the mandates.
Tony NikolicGUEST
In terms of the fertility issues, I conducted a Freedom of Information on our Therapeutic Goods Administration early on in 2021.
Tony NikolicGUEST
And I said, well, the request through another party was, tell us what the adverse effects of these vaccines are.
Tony NikolicGUEST
And they said, well, we don't know the genome toxicity, the carcinogenicity or the fertility issues.
Jessica YunGUEST
They really, you know, went after Choice as being, you know, they're not the regulator.
Jessica YunGUEST
They're not the TGA.
Jessica YunGUEST
They're not the ones who are in charge or get to have the final say on this kind of thing.
Jessica YunGUEST
So it did become Choice versus Ultraviolet.
Lauren IronmongerGUEST
Yeah, so I think there's two things that are really worth pointing out here for context.
Lauren IronmongerGUEST
And the first is that, you know, as Ava sort of said in her video, choice is not a regulator.
Lauren IronmongerGUEST
However, that said, the regulator in Australia, the TGA, they do not do their own testing of sunscreens.
Lauren IronmongerGUEST
They rely on brands to do that and hold that information.
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