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What's new
83 result(s) found, displaying 1 to 25
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PageNew Active Substance (NAS) work sharing initiative through ACCESS consortium.
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PageThe ACCESS Consortium has launched the Generic Medicines Work Initiative, an innovative work sharing model for generic applications
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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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Corporate reportsWe conduct an annual stakeholder survey to improve the way we work with our stakeholders and help report on our key performance indicators.
The report includes data and feedback from the general public (consumers), people and organisations with a TGA business services account (opt-in stakeholders), and state and territory government representatives. -
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PageInformation about current processing times, workload, priorities, and key messages for GMP Clearance applications.
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Safety alertsBrahmi Vati tablets pose a serious risk to your health and should not be taken.
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Safety alertsKumar Kalyan Rasa tablets pose a serious risk to your health and should not be taken.
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Safety alertsManasamitra Vakakam tablets pose a serious risk to your health and should not be taken.
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Regulatory decision noticesListed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2025, which commenced on 10 December 2025.
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Australian public assessment report (AusPar)Osenvelt prevention of skeletal related events in patients with multiple myeloma and in patients with bone metastases from solid tumours. Stoboclo the treatment of osteoporosis in postmenopausal women. Stoboclo significantly reduces the risk of vertebral, non-vertebral and hip fractures.
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PageCheck this page for key information and updates on the Ozempic shortage.
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Media releasesWe have issued an infringement notice, to the value of $19,800, to PERDAY'S HEALTH FUNCTIONAL FOOD (AU) PTY LTD (Perdays Australia) for the alleged unlawful advertising of a listed medicine.
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DatasetDatabase of consents to import, supply or export therapeutic goods that do not comply with standards.
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PageKey information and updates about the shortage of metformin immediate-release tablets.
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Decision treeUse this decision tree to assist you to determine if GMP licencing or certification is required.
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PageSerious Scarcity Substitution Instruments (SSSIs) allow community pharmacists to substitute specific medicines without prior approval from the prescriber so long as the permitted circumstances within the SSSI are met.
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Medicine shortage alertsPharmacists can substitute 10 mg simvastatin tablets during the shortage of the 5 mg tablets.
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Market actionsVitality Brands Worldwide Pty Ltd is recalling three batches of Cancer Council Sunscreen Clear Zinc Kids SPF50+ 110g due to the potential for the product to become separated.
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PageInformation about influenza reference reagents for testing influenza vaccines and how to order them.
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FormsAs of 25 June 2024, use this PDF form to order Influenza Reagents.
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DatasetResults and outcomes of the TGA’s 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 19 listed medicines
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BlogHave you experienced an issue with a medicine or medical device?
Every report is important. Reports help us monitor the safety of medicines, vaccines and medical devices.