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What's new
76 result(s) found, displaying 51 to 75
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TransactionReport non-compliant advertisement for a medicine, medical device or any other type of therapeutic good, using our online portal.
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PageLearn how to electronically submit UDI records using GS1’s National Product Catalogue (NPC).
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PageForms are used by sponsors, agents and manufacturers to apply for access to TGA Business Services.
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PageApply for access and manage your account details.
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Safety updatesWe are reviewing new information that has raised concerns regarding the integrity and reliability of the clinical trial data that supported the approval of TAVNEOS (avacopan) in Australia.
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Scheduling decisions (final)This web publication constitutes a notice for amendments to the current Poisons Standard made under section 52D(2) of the Therapeutic Goods Act 1989
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PageYou can access unapproved therapeutic goods in certain circumstances. Find out who can apply, what you can access and what to do before you apply.
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Media releasesTGA has issued an infringement notice, to the value of $19,800, to Cellife Health Care Pty Ltd (Cellife) for the alleged supply of a listed medicine that did not comply with an applicable standard, in contravention of the Therapeutic Goods Act 1989
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PageA list of Artificial Intelligence (AI) enabled medical devices included in the Australian Register of Therapeutic Goods (ARTG).
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PageThe EU MDR transition web publication service provides notifications to providers and consumers going through low-risk changes, as part of the transition.
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PageInformation about current processing times, workload, priorities, and key messages for GMP Clearance applications.
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News articlesFollowing a public consultation process between 24 November 2025 – 10 February 2026, the TGA has adopted 23 international scientific guidelines
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Safety alertsProduct warnings across the GLP-1 RA class of medicines have been updated due to the potential for these products to cause a rare, but severe, form of eye disorder.
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Safety updatesProduct warnings across the glucagon-like-peptide-1 receptor agonist (GLP-1 RA) class of medicines have been updated due to the potential for these products to cause a rare, but severe, form of eye disorder.
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Regulatory decision noticesWe have added our recent decisions to the list of Australian manufacturers licensed by the TGA.
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Australian Public Assessment Report (AusPAR)Tzield is indicated to delay the onset of Stage 3 type 1 diabetes mellitus (T1D) in adult and paediatric patients aged 8 years and older with Stage 2 type 1 diabetes mellitus.
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PageView published decisions relating to the granting of licences for the manufacture of therapeutic goods in Australia.
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Australian Public Assessment Report (AusPAR)Redemplo (plozasiran sodium) has been approved as an adjunct to diet to reduce triglyceride levels for adult patients with familial chylomicronaemia syndrome (FCS) for whom standard triglyceride lowering therapies have been inadequate.
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PageView published decisions relating to the revocation of licences for the manufacture therapeutic goods in Australia.
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PageView published decisions relating to the suspension of licences for the manufacture of therapeutic goods in Australia.
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PageFind out answers to frequently asked questions about advertising cosmetic injection services and our guidelines.
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PageUnderstand our requirements for advertising price lists for therapeutic goods that are prohibited from advertising to consumers. Relates to Part 9 of the Advertising Code.
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GuidanceGuidance about how to advertise therapeutic goods exclusively to health professionals.
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GuidanceThis Guidance explains part 9 of the Code, which has requirements about advertising the price of prescription medicines and certain pharmacist-only medicines to the public.
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User guideA guide for using the TGA Business services (TBS) portal for listed and assessed listed medicine applications.