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What's new
114 result(s) found, displaying 1 to 25
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ConsultationThe Therapeutic Goods Administration (TGA) is seeking public comment on proposed changes to the Therapeutic Goods (Permissible Ingredients) Determination relating to listed medicines containing vitamin B6, namely pyridoxine hydrochloride, pyridoxal 5-phosphate and pyridoxal 5-phosphate monohydrate.
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ConsultationHave your say about the content and level of detection for ethylene oxide, propylene oxide and epichlorohydrin in end use products.
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PageInformation about the shortages of HRT products for patients and healthcare professionals
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PageFindings from the review are informing policy options for regulating digital mental health tools (DMHTs).
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Regulatory decision noticesThis instrument is made under subclause 2(3)(a) of Schedule 5A to the Therapeutic Goods Regulations 1990.
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Compositional guidelinesCompositional guideline for bacillus coagulans strain ATCC PTA-126829 permitted for use in listed medicines.
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Corporate reportsOutcomes of the review of digital scribes supplied in Australia.
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Compositional guidelinesCompositional guideline for gamma glutamylcysteine permitted for use in listed medicines.
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Compositional guidelinesCompositional guideline for hydrocarbons, C6-C20, polymers, hydrogenated permitted for use in listed medicines.
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Compositional guidelinesCompositional guideline for magnesium L-threonate monohydrate permitted for use in listed medicines.
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Compositional guidelinesCompositional guideline for mitoquinol mesilate permitted for use in listed medicines.
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News articlesOutcomes of our review of digital scribes supplied in Australia.
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DatasetSearch approvals to import and supply medicines not in the Australian Register of Therapeutic Goods (ARTG) to address medicine shortages.
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Compositional guidelinesCompositional guideline for styrene/isoprene/styrene block copolymer permitted for use in listed medicines.
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GuidanceGuidance about how Clinical Decision Support System (CDSS) software is regulated. Find out when this software is exempt from inclusion in the Australian Register of Therapeutic Goods (ARTG).
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News articlesListed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026.
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Market actionsThe Australian sponsor for the prescription medicine TAVNEOS (avacopan) has advised us of their intent to withdraw it from the Australian Register of Therapeutic Goods.
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PageRead the latest enhancements and fixes to the Australian UDI Database.
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Australian Public Assessment Report (AusPAR)Fetroja (cefiderocol) has been approved for the treatment of infections due to proven or strongly suspected carbapenem-resistant aerobic Gram-negative organisms in adults with limited treatment options, including complicated urinary tract infections, pyelonephritis, hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.
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PageThe Freedom of Information disclosure log gives access to information we've released in response to an FOI request.
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DatasetView prescription medicines eligible for orphan drug status, registration via priority review or provisional approval.
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DatasetSearch our database of sponsor-requested cancellations from the ARTG.
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Australian Public Assessment Report (AusPAR)Hibruka has provisional approval in Australia for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). The decision to approve this indication has been made on the basis of overall response rate (ORR). Continued approval of this indication depends on verification and description of benefit in confirmatory trials.