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What's new
114 result(s) found, displaying 76 to 100
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ConsultationWe are seeking feedback on proposed changes to support automated decision making (ADM) for applications to change listed medicines.
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DatasetRead our results and outcomes of listed medicine compliance reviews.
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News articlesWe've updated the Listed Medicine Compliance Reports database with the results of compliance reviews covering 7 listed medicines.
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PageWe are working on the outcomes of the TGA's review of artificial intelligence (AI) and medical device software regulation.
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PageApprovals under section 41HD enable sponsors to import and supply specific medical devices during supply emergencies under special exemptions and conditions.
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PageUnderstand which medical devices are subject to UDI requirements and how the requirements apply across different device types.
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Australian Public Assessment Report (AusPAR)Cenrifki (tolebrutinib) is indicated in adults for the treatment of non-relapsing Secondary Progressive Multiple Sclerosis (nrSPMS) and to slow disability accumulation in the absence of relapse activity in adults with nrSPMS.
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News articlesWe have improved the way we present our Product Information (PI) safety updates to help you find the information you need.
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PageInformation for sponsors about the requirement of medicine labelling in Australia
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PageFind information on labelling and packaging for medicines and biologicals.
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News articlesNew medicine labelling standards have been published to replace TGO 91 and TGO 92. Sponsors will have a 5-year transition period to update labels.
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PageInformation for health professionals about medicines with safety related updates to their Product Information.
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PageStandards for labels and packaging of medicines and biologicals.
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News articlesWe have published new guidance to help journalists and news organisations understand when media reporting on therapeutic goods may be regulated as advertising.
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PageSometimes it is necessary to specify an Australian standard, either for a particular type of therapeutic good or to specify particular labelling, packaging or other requirements. In these situations, a Therapeutic Goods Order (TGO) is published.
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FormsReport suspected adverse reactions to vaccines, prescription medicines, over-the-counter medicines and complementary medicines.
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PageRead about court actions. It is our practice to publish details of regulatory compliance decisions and actions on our website.
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GuidanceThis guidance is for journalists and news organisations and explains when news reports about therapeutic goods may be regulated as advertising.
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Former company and directors behind BioV8 to face court for alleged unlawful advertising of peptides
Media releasesWe have started Federal Court proceedings against BioV8 (now in liquidation) and its former directors, alleging they breached the Therapeutic Goods Act 1989 by unlawfully advertising prescription-only therapeutic products, including peptides. -
FormsReport a suspected adverse event following immunisation (AEFI) to the TGA. Find out what information to provide and how your report supports vaccine safety monitoring in Australia.
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PageFind contact details for the state and territory recall coordinators as well as the Australian recall coordinator.
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PageLearn about the requirements for advertising therapeutic goods in specific circumstances, such as social media, and for specific types of products, like weight loss injections.
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Australian Public Assessment Report (AusPAR)Zoladex (goserelin) has been approved for the management of oestrogen-receptor positive early and advanced breast cancer in pre- and peri-menopausal women.
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Prescription medicine decision summaryZoladex is approved for the management of oestrogen-receptor (ER)-positive early and advanced breast cancer in pre- and peri- menopausal women. Zoladex contains the active ingredient goserelin.
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PageRevised content on supplying medicines during a shortage under section 19A