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BioWorld - Friday, April 3, 2026
Home » Topics » Regulatory » TGA

TGA
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Paul Anderson

TGA clears Orthocell’s regenerative nerve repair device

March 21, 2022
By Tamra Sami
Australia’s Therapeutics Goods Administration (TGA) cleared Orthocell Ltd.’s regenerative nerve repair device, Remplir, a biological scaffold that mimics the outer layer of the peripheral nerve to facilitate nerve repair.
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Coin inserted into Australian map

TGA: More feedback needed on repurposing drugs

March 15, 2022
By Mari Serebrov
Given the challenges in repurposing medicines, Australia’s TGA opened a second consultation on the subject March 10.
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TGA: More feedback needed on repurposing drugs

March 10, 2022
By Mari Serebrov
Given the challenges in repurposing medicines, Australia’s Therapeutics Goods Administration (TGA) opened a second consultation on the subject March 10.
Read More
Flag of Australia, sky background

Companies favor mandatory reporting of device-related adverse events, wary of data integrity

Feb. 25, 2022
By Tamra Sami
PERTH, Australia – Nearly three-fourths of medical device stakeholders supported introducing mandatory reporting of medical device-related adverse events by health care facilities in Australia, but many raised concerns about data duplication and integrity.
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Gavel and stacks of coins

Australia’s TGA to increase industry fees to retain its cost recovery model

Feb. 1, 2022
By Tamra Sami
PERTH, Australia – Australia’s Therapeutic Good Administration (TGA) plans to increase all fees and charges to industry by 2.6% for the 2022 to 2023 financial year, and it is seeking feedback on proposed options.
Read More
Gavel and stacks of coins

Australia’s TGA to increase industry fees to retain its cost recovery model

Jan. 27, 2022
By Tamra Sami
PERTH, Australia – Australia’s Therapeutic Good Administration (TGA) plans to increase all fees and charges to industry by 2.6% for the 2022 to 2023 financial year, and it is seeking feedback on proposed options.
Read More
Map of Australia, vaccine vial and syringe

Australia adds Novavax vaccine and antivirals from Pfizer, MSD to COVID-19 arsenal

Jan. 25, 2022
By Tamra Sami
PERTH, Australia – In preparation for easing COVID-19 restrictions and opening its international borders, Australia has added a new vaccine and two new oral antiviral therapies to its arsenal to fight the omicron variant of the SARS-CoV-2 virus that is sweeping the globe. Australia’s Therapeutic Goods Administration granted provisional approval on Jan. 20 to Biocelect Pty Ltd. (on behalf of Novavax Inc.) for its COVID-19 vaccine, Nuvaxovid, as well as two oral antiviral treatments.
Read More
Map of Australia, vaccine vial and syringe

Australia adds Novavax vaccine and antivirals from Pfizer, MSD to COVID-19 arsenal

Jan. 25, 2022
By Tamra Sami
PERTH, Australia – In preparation for easing COVID-19 restrictions and opening its international borders, Australia has added a new vaccine and two new oral antiviral therapies to its arsenal to fight the omicron variant of the SARS-CoV-2 virus that is sweeping the globe. Australia’s Therapeutic Goods Administration granted provisional approval on Jan. 20 to Biocelect Pty Ltd. (on behalf of Novavax Inc.) for its COVID-19 vaccine, Nuvaxovid, as well as two oral antiviral treatments.
Read More
Map of Australia, vaccine vial and syringe

Australia adds Novavax vaccine and antivirals from Pfizer, MSD to COVID-19 arsenal

Jan. 20, 2022
By Tamra Sami
PERTH, Australia – In preparation for easing COVID-19 restrictions and opening its international borders, Australia has added a new vaccine and two new oral antiviral therapies to its arsenal to fight the omicron variant of the SARS-CoV-2 virus that is sweeping the globe. Australia’s Therapeutic Goods Administration granted provisional approval on Jan. 20 to Biocelect Pty Ltd. (on behalf of Novavax Inc.) for its COVID-19 vaccine, Nuvaxovid, as well as two oral antiviral treatments.
Read More
Australian flag on laptop screen with health professional

TGA issues guidance on software requirements for COVID-19 rapid antigen self-tests

Jan. 12, 2022
By Tamra Sami
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) released guidance for sponsors and manufacturers on regulatory requirements for software to be used with COVID-19 rapid antigen self-tests that are intended to analyze and interpret tests results.
Read More
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