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Home » Topics » Regulatory » TGA

TGA
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TGA eyes mutual recognition with EU for in vitro diagnostics

June 21, 2023
By Mark McCarty
The EU’s In Vitro Diagnostic Regulation (IVDR) has not yet been fully implemented, but Australia’s Therapeutic Goods Authority (TGA) is wasting no time attempting to harmonize with the IVDR.
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Tracey Duffy speaking at podium

Consumer and industry engagement guide Australia’s device reforms

June 8, 2023
By Tamra Sami
Recent regulatory reforms to Australia’s medical device framework have shown Australia’s Therapeutic Goods Administration (TGA) a new way of collaborating with industry to make improvements and ensure patient safety, said Tracey Duffy, deputy secretary for the TGA’s Medical Devices and Product Quality Division, during the recent Ausmedtech conference in Adelaide.
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Joel Latham, CEO, Incannex Healthcare Ltd.
Newco news

Incannex is changing treatment paradigms with pipeline of psychedelics and cannabinoids

June 6, 2023
By Tamra Sami
Incannex Healthcare Ltd. had quietly been developing its commercialization plans for psychedelic clinics well before Australia’s Therapeutic Goods Administration announced it would allow psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) to be prescribed by authorized psychiatrists for treatment-resistant depression and post-traumatic stress disorder.
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Joel Latham, CEO, Incannex Healthcare Ltd.
Newco news

Incannex is changing treatment paradigms with pipeline of psychedelics and cannabinoids

June 2, 2023
By Tamra Sami
Incannex Healthcare Ltd. had quietly been developing its commercialization plans for psychedelic clinics well before Australia’s Therapeutic Goods Administration announced it would allow psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) to be prescribed by authorized psychiatrists for treatment-resistant depression and post-traumatic stress disorder.
Read More
Injection syringes

Demand for obesity drugs a golden opportunity for counterfeits

May 30, 2023
By Mari Serebrov
Mixing a trendy drug for a global health problem like obesity with a demand that far exceeds the supply cooks up a recipe too good for counterfeiters to ignore.
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Demand for obesity drugs a golden opportunity for counterfeits

May 26, 2023
By Mari Serebrov
Mixing a trendy drug for a global health problem like obesity with a demand that far exceeds the supply cooks up a recipe too good for counterfeiters to ignore. That’s the problem patients are facing with Novo Nordisk A/S’ semaglutide products, Ozempic and Wegovy, which have been in short supply all over the world since early last year due to significant, and unexpected, demand for weight management.
Read More
Drug vial and syringe
Immuno-oncology

Mabwell's IL-11-targeting monoclonal antibody 9MW3811 cleared to enter clinic

March 1, 2023
Mabwell (Shanghai) Bioscience Co. Ltd. has received approval of its IND application from Australia's Therapeutic Goods Administration (TGA) for 9MW3811 injection for tumors and pulmonary fibrosis.
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Silhouette made of crumpled paper illustrating depression

Australia to allow psychiatrists to prescribe psilocybin and MDMA for depression, PTSD

Feb. 7, 2023
By Tamra Sami
Beginning July 1, Australia’s Therapeutic Goods Administration will allow medicines containing the psychedelic substances psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) to be prescribed by authorized psychiatrists for certain mental health conditions.
Read More
Newco news

After fecal microbiota approval, Biomebank to develop synthetic treatments for gut microbiota

Jan. 17, 2023
By Tamra Sami
Following Therapeutic Goods Administration approval of its first-generation donor-derived microbiome-based therapy, Biomictra, for recurrent Clostridioides difficile infection, Australia’s Biomebank is scaling up to meet increasing global demand for fecal microbiota products and is developing a more scalable second-generation synthetic product.
Read More
3D representation of tumor
Immuno-oncology

Immunos cleared to begin clinical testing in Australia with IOS-1002 for solid tumors

Jan. 17, 2023
Immunos Therapeutics AG has received full ethical institutional approval from the Human Research Ethics Committee (HREC) and regulatory approval from the Australian Therapeutic Goods Administration (TGA) to conduct a phase I trial of its lead program IOS-1002 in Australia.
Read More
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