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What's new
101 result(s) found, displaying 26 to 50
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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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PageKey information about the shortage for patients, carers and health care professionals
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PageInformation about what to include in the Product Information (PI) and Consumer Medicine Information (CMI) for products included in the Black Triangle Scheme.
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News articlesSponsors and manufacturers intending to export medicines and medical devices to Indonesia should be aware of new and emerging halal certification requirements under Indonesia’s Halal Product Assurance framework.
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FormsSponsors must report every six months in relation to unapproved therapeutic goods supplied under the SAS and Authorised Prescriber (AP) schemes.
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Australian public assessment report (AusPar)Audenz (influenza virus haemagglutinin) is indicated for active immunisation against influenza A in persons from 6 months of age and older in an officially declared pandemic.
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GuidanceGuidance for preparing a technical file review, as part of your application to include an in-vitro medical device (IVD) in the Australian Register of Therapeutic Goods.
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Prescription medicine decision summaryRedemplo has been approved as an adjunct to diet to reduce triglyceride levels for adult patients with familial chylomicronaemia syndrome (FCS).
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BlogDo you know that there are strict rules when it comes to advertising therapeutic goods? If you see an ad that looks like it’s breaking the rules, report it using our online portal.
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PageAdvice on the implications of Brexit for therapeutic goods supply in Australia.
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PageMedical devices priority applicant determination notices and eligibility for priority review pathway.
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PageTGA-Industry Working Group on Good Manufacturing Practice (TIWGG) meeting summaries.
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GuidanceThis guidance explains how overseas assessments can support our medical device certification and registration processes.
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GuidanceGuidance on the use of market authorisation evidence from comparable overseas regulators for medical device applications.
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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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PageInformation and updates about the shortages of cyclophosphamide and ifosfamide injections.
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Meeting statementsAdvisory Committee on Vaccines meeting statement 56
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PageFind out about our compliance review activities for listed medicines and how to avoid common compliance issues.
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PageThe TGA will be initiating targeted compliance reviews of selected listed medicines to evaluate evidence held to support indications for exercise performance.
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News articlesThe TGA initiated targeted compliance reviews of select listed medicines containing Magnesium to verify whether sponsors had appropriate evidence to support their medicine’s exercise performance claims.
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Australian public assessment report (AusPar)Ekterly (sebetralstat) has been approved for the treatment of hereditary angioedema attacks caused by C1 inhibitor deficiency or dysfunction in patients aged 12 years and older.
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Safety alertsWe are warning consumers about the risks of importing and using unapproved peptide products that are promoted online.
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PageThe TGA is introducing a streamlined Consent to Supply process for Unique Device Identification related Essential Principles.
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PageExpected new shortage during May 2026 is not occurring.
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DatasetSearch our database of sponsor-requested cancellations from the ARTG.