https://www.tga.gov.au/ News en https://www.tga.gov.au/news/news/new-medicine-adverse-event-search-sponsors We have launched a new search feature in the Adverse Event Management System (AEMS) portal.  As a sponsor, you can access adverse event reports about your medicines and biologicals. Mon, 20 Nov 23 12:00:00 +0000 Mon, 20 Nov 23 12:00:00 +0000 https://www.tga.gov.au/news/news/new-medicine-adverse-event-search-sponsors https://www.tga.gov.au/news/news/global-event-promotes-side-effect-reporting It's #MedSafetyWeek, a global movement to encourage the reporting of medicine side effects (known as ‘adverse events’). You can join in and help spread the word. Mon, 06 Nov 23 12:00:00 +0000 Mon, 06 Nov 23 12:00:00 +0000 https://www.tga.gov.au/news/news/global-event-promotes-side-effect-reporting https://www.tga.gov.au/news/news/warnings-supply-and-advertising-haytox ‘Haytox’ has not been approved by the TGA or included in the Australian Register of Therapeutic Goods (ARTG). Thu, 19 Oct 23 12:00:00 +0000 Thu, 19 Oct 23 12:00:00 +0000 https://www.tga.gov.au/news/news/warnings-supply-and-advertising-haytox https://www.tga.gov.au/news/news/covid-19-vaccine-janssen On 28 August 2023, Janssen-Cilag Pty Ltd voluntarily cancelled COVID-19 VACCINE JANSSEN from the Australian Register of Therapeutic Goods (ARTG). Mon, 18 Sep 23 12:00:00 +0000 Mon, 18 Sep 23 12:00:00 +0000 https://www.tga.gov.au/news/news/covid-19-vaccine-janssen https://www.tga.gov.au/news/news/medical-devices-vigilance-program-pilot We are starting a new medical device pilot program to support medical device sponsors to comply with their ongoing post-market surveillance responsibilities. Mon, 11 Sep 23 12:00:00 +0000 Mon, 11 Sep 23 12:00:00 +0000 https://www.tga.gov.au/news/news/medical-devices-vigilance-program-pilot https://www.tga.gov.au/news/news/changes-regulation-sports-supplements-medicinal-dosage-forms From 30 November 2023, some sports supplements will be regulated as therapeutic goods and must be included in the Australian Register of Therapeutic Goods (ARTG). Fri, 01 Sep 23 12:00:00 +0000 Fri, 01 Sep 23 12:00:00 +0000 https://www.tga.gov.au/news/news/changes-regulation-sports-supplements-medicinal-dosage-forms https://www.tga.gov.au/news/news/scam-alert We are aware that a small number of people have received calls from scammers impersonating the TGA. Fri, 01 Sep 23 12:00:00 +0000 Fri, 01 Sep 23 12:00:00 +0000 https://www.tga.gov.au/news/news/scam-alert https://www.tga.gov.au/news/news/post-market-review-facemasks-closed The COVID-19 pandemic post-market review of facemasks is now finished. Thu, 31 Aug 23 12:00:00 +0000 Thu, 31 Aug 23 12:00:00 +0000 https://www.tga.gov.au/news/news/post-market-review-facemasks-closed https://www.tga.gov.au/news/news/changes-choline-salicylate-access-start-1-october-2023 Find out about changes to choline salicylate access, starting from October 2023. Thu, 31 Aug 23 12:00:00 +0000 Thu, 31 Aug 23 12:00:00 +0000 https://www.tga.gov.au/news/news/changes-choline-salicylate-access-start-1-october-2023 https://www.tga.gov.au/news/news/product-information-inserts-are-no-longer-required-injectable-medicines-administered-health-professionals Find out how Product Information inserts won’t be required in the packaging of injectable medicines, given by health professionals, starting from September 2023. Wed, 30 Aug 23 12:00:00 +0000 Wed, 30 Aug 23 12:00:00 +0000 https://www.tga.gov.au/news/news/product-information-inserts-are-no-longer-required-injectable-medicines-administered-health-professionals https://www.tga.gov.au/news/news/new-reporting-requirements-medicine-shortages Companies supplying medicines in Australia will be required to provide additional information if their products go into shortage. Thu, 17 Aug 23 12:00:00 +0000 Thu, 17 Aug 23 12:00:00 +0000 https://www.tga.gov.au/news/news/new-reporting-requirements-medicine-shortages https://www.tga.gov.au/news/news/vaping-products-medicinal-cannabis-and-wellness-industry-included-2023-24-compliance-and-enforcement-priorities Read about our import, advertising and supply compliance priorities for 2023-24. Tue, 25 Jul 23 12:00:00 +0000 Tue, 25 Jul 23 12:00:00 +0000 https://www.tga.gov.au/news/news/vaping-products-medicinal-cannabis-and-wellness-industry-included-2023-24-compliance-and-enforcement-priorities https://www.tga.gov.au/news/news/sponsors-and-manufacturers-reminded-about-upcoming-financial-deadlines A reminder about financial deadlines that are approaching for sponsors and manufacturers. Wed, 12 Jul 23 12:00:00 +0000 Wed, 12 Jul 23 12:00:00 +0000 https://www.tga.gov.au/news/news/sponsors-and-manufacturers-reminded-about-upcoming-financial-deadlines https://www.tga.gov.au/news/news/nitrosamine-risk-assessment-category-1-prescription-medicine-registration-applications If you're a sponsor, it's important to be aware of the global issue of nitrosamine impurities in medicines. Find out what steps you should take. Mon, 10 Jul 23 12:00:00 +0000 Mon, 10 Jul 23 12:00:00 +0000 https://www.tga.gov.au/news/news/nitrosamine-risk-assessment-category-1-prescription-medicine-registration-applications https://www.tga.gov.au/news/news/deadline-certain-medical-device-reforms-be-extended The Government has agreed that regulatory amendments should be drafted to extend the transition arrangements for certain medical device reforms to 1 July 2029. Fri, 07 Jul 23 12:00:00 +0000 Fri, 07 Jul 23 12:00:00 +0000 https://www.tga.gov.au/news/news/deadline-certain-medical-device-reforms-be-extended https://www.tga.gov.au/news/news/update-mdma-and-psilocybin-access-and-safeguards-1-july-2023 Stay updated about the commencement of MDMA and psilocybin for the treatment of certain mental illnesses. Mon, 03 Jul 23 12:00:00 +0000 Mon, 03 Jul 23 12:00:00 +0000 https://www.tga.gov.au/news/news/update-mdma-and-psilocybin-access-and-safeguards-1-july-2023 https://www.tga.gov.au/news/news/new-guidance-published-manufacturer-evidence-ivd-medical-devices To help sponsors and manufacturers transition to new manufacturer evidence. Tue, 20 Jun 23 12:00:00 +0000 Tue, 20 Jun 23 12:00:00 +0000 https://www.tga.gov.au/news/news/new-guidance-published-manufacturer-evidence-ivd-medical-devices https://www.tga.gov.au/news/news/tga-supports-mhras-new-international-recognition-framework-medicines These international recognition routes, which have been facilitated by existing international partnerships such as those developed through the Access Consortium and Project Orbis, are part of a new international recognition framework for medicines that is specific to the UK following their exit from the European Union. Fri, 02 Jun 23 12:00:00 +0000 Fri, 02 Jun 23 12:00:00 +0000 https://www.tga.gov.au/news/news/tga-supports-mhras-new-international-recognition-framework-medicines https://www.tga.gov.au/news/news/lifeblood-sexual-activity-and-prep-deferrals The TGA has approved applications submitted by Australian Red Cross Lifeblood (Lifeblood) to remove most of the sexual activity ineligibility criteria for plasma donors used for fractionated products only. Lifeblood refers to this approach as ‘the plasma pathway’. Tue, 30 May 23 12:00:00 +0000 Tue, 30 May 23 12:00:00 +0000 https://www.tga.gov.au/news/news/lifeblood-sexual-activity-and-prep-deferrals https://www.tga.gov.au/news/news/phase-out-iso-13485-certificates-ivd-medical-devices Transition period for accepting ISO 13485 ends 26 May 2023. Thu, 25 May 23 12:00:00 +0000 Thu, 25 May 23 12:00:00 +0000 https://www.tga.gov.au/news/news/phase-out-iso-13485-certificates-ivd-medical-devices https://www.tga.gov.au/news/news/updates-prescribing-medicines-pregnancy-database-may-2023 The Prescribing Medicines in Pregnancy database has now been updated. Wed, 17 May 23 12:00:00 +0000 Wed, 17 May 23 12:00:00 +0000 https://www.tga.gov.au/news/news/updates-prescribing-medicines-pregnancy-database-may-2023 https://www.tga.gov.au/news/news/tga-publishes-updated-guidelines-sunscreens The TGA has updated the Australian Regulatory Guidelines for Sunscreens (ARGS) to align with the data requirements for all ingredients proposed to be included in the Therapeutic Goods (Permissible Ingredients) Determination Tue, 09 May 23 12:00:00 +0000 Tue, 09 May 23 12:00:00 +0000 https://www.tga.gov.au/news/news/tga-publishes-updated-guidelines-sunscreens https://www.tga.gov.au/news/news/eu-mdr-transition-extension The TGA will recognise the extended transition for the European Union Medical Device Regulation (EU MDR). Fri, 05 May 23 12:00:00 +0000 Fri, 05 May 23 12:00:00 +0000 https://www.tga.gov.au/news/news/eu-mdr-transition-extension https://www.tga.gov.au/news/news/surveys-medical-devices-manufactured-point-care We are conducting surveys to collect information about medical devices manufactured at the point-of-care. Fri, 28 Apr 23 12:00:00 +0000 Fri, 28 Apr 23 12:00:00 +0000 https://www.tga.gov.au/news/news/surveys-medical-devices-manufactured-point-care https://www.tga.gov.au/news/news/first-mpox-monkeypox-test-kit-approved-australia The TGA has approved the first commercially supplied test kit for the detection of Mpox (monkeypox) virus. Fri, 14 Apr 23 12:00:00 +0000 Fri, 14 Apr 23 12:00:00 +0000 https://www.tga.gov.au/news/news/first-mpox-monkeypox-test-kit-approved-australia https://www.tga.gov.au/news/news/dual-labelled-medicines-begin-transition-sole-medicine-ingredient-names-soon Find out about new transition arrangements for dual labelled ingredient names. Wed, 05 Apr 23 12:00:00 +0000 Wed, 05 Apr 23 12:00:00 +0000 https://www.tga.gov.au/news/news/dual-labelled-medicines-begin-transition-sole-medicine-ingredient-names-soon https://www.tga.gov.au/news/news/changes-medical-device-essential-principles-nanomaterials Essential principle 7 now mentions nanomaterials explicitly (see EP 7.7) Wed, 29 Mar 23 12:00:00 +0000 Wed, 29 Mar 23 12:00:00 +0000 https://www.tga.gov.au/news/news/changes-medical-device-essential-principles-nanomaterials https://www.tga.gov.au/news/news/tgas-new-powers-will-help-reduce-impact-medicine-shortages-patients From 22 March 2023 changes to the Therapeutic Goods Act 1989 will help alleviate the effects of medicine shortages on patients. Fri, 24 Mar 23 12:00:00 +0000 Fri, 24 Mar 23 12:00:00 +0000 https://www.tga.gov.au/news/news/tgas-new-powers-will-help-reduce-impact-medicine-shortages-patients https://www.tga.gov.au/news/news/lapse-provisional-registration-tecentriq-atezolizumab-treatment-locally-advanced-or-metastatic-triple-negative-breast-cancer-mtnbc Provisional registration of Tecentriq (atezolizumab) for the treatment in mTNBC will lapse on 22 March 2023. Wed, 22 Mar 23 12:00:00 +0000 Wed, 22 Mar 23 12:00:00 +0000 https://www.tga.gov.au/news/news/lapse-provisional-registration-tecentriq-atezolizumab-treatment-locally-advanced-or-metastatic-triple-negative-breast-cancer-mtnbc https://www.tga.gov.au/news/news/update-effectiveness-monoclonal-antibodies-against-covid-variants The TGA is aware of concerns about decreased effectiveness of monoclonal antibodies against the COVID-19 caused by emerging SAR-COV-2 variants. At this stage, the regulatory status of the products remain unchanged in Australia. Thu, 02 Mar 23 12:00:00 +0000 Thu, 02 Mar 23 12:00:00 +0000 https://www.tga.gov.au/news/news/update-effectiveness-monoclonal-antibodies-against-covid-variants https://www.tga.gov.au/news/news/daen-medicines-update In response to user feedback, we have been trialling a beta version of the DAEN – medicines since June 2022 alongside the older database. Thu, 16 Feb 23 12:00:00 +0000 Thu, 16 Feb 23 12:00:00 +0000 https://www.tga.gov.au/news/news/daen-medicines-update https://www.tga.gov.au/news/news/limited-ozempic-supplies-commence-distribution-australia Supplies of Ozempic (semaglutide) have begun distribution in Australia but will remain quite limited for some time. Wed, 15 Feb 23 12:00:00 +0000 Wed, 15 Feb 23 12:00:00 +0000 https://www.tga.gov.au/news/news/limited-ozempic-supplies-commence-distribution-australia https://www.tga.gov.au/news/news/changes-applying-evaluation-new-substances-listed-medicines New guidelines and mandatory requirements for listed medicines ingredients have come into effect on 1 February 2023. Wed, 01 Feb 23 12:00:00 +0000 Wed, 01 Feb 23 12:00:00 +0000 https://www.tga.gov.au/news/news/changes-applying-evaluation-new-substances-listed-medicines https://www.tga.gov.au/news/news/antibiotics-shortage-australia Current antibiotics shortages in Australia include amoxicillin, amoxicillin/clavulanic acid, cefalexin, metronidazole and trimethoprim. Wed, 11 Jan 23 12:00:00 +0000 Wed, 11 Jan 23 12:00:00 +0000 https://www.tga.gov.au/news/news/antibiotics-shortage-australia https://www.tga.gov.au/news/news/tga-operations-over-holiday-period-2022-23 The TGA will have limited operations from Friday 23 December 2022 until Tuesday 3 January 2023 Wed, 21 Dec 22 12:00:00 +0000 Wed, 21 Dec 22 12:00:00 +0000 https://www.tga.gov.au/news/news/tga-operations-over-holiday-period-2022-23 https://www.tga.gov.au/news/news/access-generic-medicines-work-sharing-initiative-update The Generic Medicines Work-Sharing Initiative has updated its Operational Procedures document and Expression Of Interest form. Wed, 21 Dec 22 12:00:00 +0000 Wed, 21 Dec 22 12:00:00 +0000 https://www.tga.gov.au/news/news/access-generic-medicines-work-sharing-initiative-update https://www.tga.gov.au/news/news/updates-prescribing-medicines-pregnancy-database-december-2022 The Prescribing Medicines in Pregnancy database has now been updated. Wed, 21 Dec 22 12:00:00 +0000 Wed, 21 Dec 22 12:00:00 +0000 https://www.tga.gov.au/news/news/updates-prescribing-medicines-pregnancy-database-december-2022 https://www.tga.gov.au/news/news/reminder-about-weight-loss-products Before you take a weight loss supplement or medicine, there are things to consider. Thu, 15 Dec 22 12:00:00 +0000 Thu, 15 Dec 22 12:00:00 +0000 https://www.tga.gov.au/news/news/reminder-about-weight-loss-products https://www.tga.gov.au/news/news/warning-advertising-ozempic-semaglutide-prohibited A warning to social media influencers and advertisers not to advertise this prescription medicine. Wed, 30 Nov 22 12:00:00 +0000 Wed, 30 Nov 22 12:00:00 +0000 https://www.tga.gov.au/news/news/warning-advertising-ozempic-semaglutide-prohibited https://www.tga.gov.au/news/news/standard-serialisation-and-data-matrix-codes-commences-1-january-2023 Find out about the requirements starting on 1 January 2023 for medicines that are serialised or include a data matrix code. Wed, 02 Nov 22 12:00:00 +0000 Wed, 02 Nov 22 12:00:00 +0000 https://www.tga.gov.au/news/news/standard-serialisation-and-data-matrix-codes-commences-1-january-2023 https://www.tga.gov.au/news/news/beware-barbie-drug-dangers-using-melanotan The TGA urges consumers to steer clear of using products containing 'Melanotan' Fri, 28 Oct 22 12:00:00 +0000 Fri, 28 Oct 22 12:00:00 +0000 https://www.tga.gov.au/news/news/beware-barbie-drug-dangers-using-melanotan https://www.tga.gov.au/news/news/pharmacovigilance-inspection-program-risk-assessment-survey The Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey is now open until 18 December 2022 for medicine sponsors to complete. Mon, 17 Oct 22 12:00:00 +0000 Mon, 17 Oct 22 12:00:00 +0000 https://www.tga.gov.au/news/news/pharmacovigilance-inspection-program-risk-assessment-survey https://www.tga.gov.au/news/news/user-experience-survey-daen-medicines-beta-version Tell us your experience using of the beta Database of Adverse Event Notifications (DAEN) - medicines. Tue, 04 Oct 22 12:00:00 +0000 Tue, 04 Oct 22 12:00:00 +0000 https://www.tga.gov.au/news/news/user-experience-survey-daen-medicines-beta-version https://www.tga.gov.au/news/news/sme-assist-workshops-and-events TGA SME Assist presents "Meeting your Obligations" a free workshop aimed at beginners who are unfamiliar with therapeutic goods regulation. Mon, 22 Aug 22 12:00:00 +0000 Mon, 22 Aug 22 12:00:00 +0000 https://www.tga.gov.au/news/news/sme-assist-workshops-and-events https://www.tga.gov.au/news/news/covid-19-vaccine-spikevax-elasomeran The TGA approved Moderna Australia’s application to transition its COVID-19 vaccine, SPIKEVAX (elasomeran), from provisional to full registration. Mon, 15 Aug 22 12:00:00 +0000 Mon, 15 Aug 22 12:00:00 +0000 https://www.tga.gov.au/news/news/covid-19-vaccine-spikevax-elasomeran https://www.tga.gov.au/news/news/tga-approval-change-blood-donation-rules-relating-vcjd-deferral The TGA has approved the removal of the geographical deferral of blood and plasma donors from the UK, which was put in place to minimise the risk of variant Creutzfeldt-Jakob disease (vCJD), commonly known as 'mad cow disease'. Mon, 25 Jul 22 12:00:00 +0000 Mon, 25 Jul 22 12:00:00 +0000 https://www.tga.gov.au/news/news/tga-approval-change-blood-donation-rules-relating-vcjd-deferral https://www.tga.gov.au/news/news/surrogate-viruses-use-disinfectant-efficacy-tests-justify-claims-against-monkeypox The TGA is providing guidance on surrogate viruses that may be used to test disinfectants making claims of efficacy against Monkeypox. Thu, 07 Jul 22 12:00:00 +0000 Thu, 07 Jul 22 12:00:00 +0000 https://www.tga.gov.au/news/news/surrogate-viruses-use-disinfectant-efficacy-tests-justify-claims-against-monkeypox https://www.tga.gov.au/news/news/covid-19-vaccine-provisional-determinations COVID-19 vaccines that have received a provisional determination from the TGA. Wed, 06 Jul 22 12:00:00 +0000 Wed, 06 Jul 22 12:00:00 +0000 https://www.tga.gov.au/news/news/covid-19-vaccine-provisional-determinations https://www.tga.gov.au/news/news/updates-prescribing-medicines-pregnancy-database-may-2022 The Prescribing Medicines in Pregnancy database has now been updated. Thu, 12 May 22 12:00:00 +0000 Thu, 12 May 22 12:00:00 +0000 https://www.tga.gov.au/news/news/updates-prescribing-medicines-pregnancy-database-may-2022 https://www.tga.gov.au/news/news/covid-19-treatment-gilead-sciences-pty-ltd-remdesivir-veklury On 10 July 2020 the Therapeutic Goods Administration (TGA) granted provisional approval to remdesivir ("Veklury", Gilead Sciences Pty Ltd) as the first treatment option for COVID-19 Fri, 06 May 22 12:00:00 +0000 Fri, 06 May 22 12:00:00 +0000 https://www.tga.gov.au/news/news/covid-19-treatment-gilead-sciences-pty-ltd-remdesivir-veklury