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This page lists items that we have published for the first time or updated in the last 7, 30 or 60 days. Use the filters to narrow results by audience, product type, content type or topic.
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Topic
- Advertising (17)
- Clinical trials (1)
- Committees and advisory bodies (4)
- Compliance and enforcement (20)
- Cosmetics (3)
- Fees and payments (4)
- Import and export (7)
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- Legislation (3)
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What's new
122 result(s) found, displaying 1 to 25
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ConsultationWe are seeking public comment on issues and proposed amendments to the Permissible Indications Determination.
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ConsultationWe are seeking feedback on the regulation of radiopharmaceuticals in Australia. These medicines contain small amounts of radioactive material, used to support the diagnosis and treatment of serious conditions, including cancer and cardiovascular disease.
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ConsultationWe are seeking feedback on proposed changes to publishing information about Good Manufacturing Practice (GMP) compliance on our website.
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Market actionsAidacare Pty Ltd has updated the Instructions for Use (IFU) for the Aspire A205 Aluminium Patient Lifter. The IFU has been enhanced to strengthen existing instructions around correct and incorrect sling attachment methods and pre-use checks.
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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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Media releasesWe have issued 3 infringement notices totalling $11,880 to a nurse for the alleged unlawful importation of unapproved cosmetic injectables, which is illegal under the Therapeutic Goods Act 1989 (the Act).
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Safety alertsWe are advising that Eagle Research Lab branded selective androgen receptor modulators (SARMs) pose a serious risk to your health and should not be taken.
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PageKnow the ways we respond to breaches such as warnings, fines and legal action.
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GuidanceThis guidance will assist you in determining if a product is a cosmetic or a therapeutic good and how to comply with Australian regulatory requirements and advertising rules for therapeutic goods.
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PageInformation about how the TGA uses and calculates the value of infringement notices
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/257026/2018.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/VEG/134716/2004
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/539146/2013
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BWP/534898/2008 rev. 2
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Safety alertsWe are advising consumers that ITCHA SSS capsules, marketed for weight management, have been found to contain oxedrine, an undisclosed prescription-only medicine.
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FormsAccess TGA medical device Conformity Assessment application forms and guidance, including requirements for supporting data and certification.
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PageThis page contains a list of therapeutic vaping goods, for use in smoking cessation or the management of nicotine dependence, that can be legally supplied in Australia. Healthcare practitioners can use this list when prescribing and supplying unapproved therapeutic vaping goods as they have been notified as complying with applicable standards.
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Australian public assessment report (AusPar)Skyclarys has been approved for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older.
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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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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/HMPC/CHMP/CVMP/201116/20051 Rev. 3
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/ICH/24235/2006 Corr.2
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PageInformation about influenza reference reagents for testing influenza vaccines and how to order them.
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News articlesFrom 1 July 2026, some medical devices supplied in Australia must meet Unique Device Identification (UDI) requirements.