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What's new
91 result(s) found, displaying 1 to 25
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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.
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PageInternational standards can support safety, quality and cyber security in medical device software.
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Market actionsEdgewell Personal Care Australia Pty Ltd is recalling all unexpired batches (nine in total) due to the potential for the lotions to become separated.
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PageWe are reviewing all ventilators, continuous positive airway pressure (CPAP), and bi-level positive airway pressure (BiPAP) devices in the ARTG.
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PageWe have identified additional devices (other than those supplied by Philips Electronics Australia Ltd) that contain PE-PUR foam material for sound abatement purpose in the breathing gas pathway.
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PageWe are reviewing all ventilator, CPAP, and BiPAP devices in the ARTG to clarify what devices incorporate sound abatement features.
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PageFind out more about our post-market review of ventilator, CPAP and BiPAP devices included in the Australian Register of Therapeutic Goods (ARTG).
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Market actionsGem Care Products Pty Ltd is recalling all unexpired batches (two in total) due to the potential for the lotions to become separated.
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Australian public assessment report (AusPar)Augtyro has been approved for the treatment of adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
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Advertising permissionApproval under section 42DF for use of restricted representations by B Braun Australia Pty Ltd
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PageFind the monographs available for over-the-counter (OTC) new medicine N2 applications.