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What's new
95 result(s) found, displaying 1 to 25
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PageInformation about current processing times, workload, priorities, and key messages for GMP Clearance applications.
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Prescription medicine decision summarymNEXSPIKE XBB.1.5 (SARS-CoV-2 spike protein (mRNA) XBB.1.5) is a vaccine approved to prevent COVID-19 caused by SARS-CoV-2, in individuals aged 12 years and older.
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PageRead the latest enhancements and fixes to the Australian UDI Database Pre-Production environment.
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Market actionsThe TGA has concerns about an increased risk of revision as shown in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) data when compared to other fixed and mobile bearing systems.
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PageWe are part of the Health Products Regulation Group (HPRG) in the Australian Government Department of Health, Disability and Ageing.
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PageResources and technical documents for Machine to Machine (M2M) HL7 SPL users in the Australian Unique Device Identification Database (AusUDID).
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Australian public assessment report (AusPar)Ospomyv, Xborso (denosumab) have been approved for the prevention and treatment of multiple bone-related pathologies.
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PageKey information and updates about the shortage of methylphenidate hydrochloride products.
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PageWe regulate some software products that support mental health care including some apps, websites, or other digital products.
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BlogIn September 2025, the Therapeutic Goods Administration (TGA) issued a public safety alert after TGA laboratory testing revealed significant dose inconsistencies in unapproved melatonin products bought from overseas websites. Some products contained up to 400% more melatonin, while others contained less than stated or none.
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Media releasesOn 3 February 2026 the TGA, with support from the NSW Police Force and the Australian Federal Police (AFP), conducted targeted enforcement action in Burwood, New South Wales, seizing more than 57,000 illegal vaping goods.
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GuidanceFind out whether your application for an umbrella-branded medicine requires a higher level of assessment.
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PageLearn how to refine your searches and use tables and graphs to interact with the data.
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PageLearn how everyone can play an important role in monitoring the safety of medicines in Australia.
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Australian public assessment report (AusPar)Rapiblyk is indicated for short‑term control of supraventricular tachycardia and ventricular rate in atrial fibrillation/flutter, and for non‑compensatory sinus tachycardia in adults. Not for chronic use.
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PageLearn about the Australian Unique Device Identification Database (AusUDID) and how to use the database to comply with UDI requirements.
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GuidanceTo use the N2 application pathway using OTC medicine monographs, you must ensure that your application meets the requirements for N2 applications.
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FormsThe completed assurances form is required in Module 1.5 of your OTC new medicine N1 application
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FormsThe completed assurances form is required in Module 1.5 of your OTC new medicine N2 application
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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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PageInformation on how to report an adverse event or concern about a medical device.
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GuidanceGuidance for healthcare facilities, including information about the requirements for data fields, timeframes for reporting and other considerations.
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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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PageWhen and how we regulate medical devices that are or use artificial intelligence technology.