Temporary Disabled. :) please Go back Latest news & updates | Therapeutic Goods Administration (TGA) www.fgks.org » Address: [go: up one dir, main page] Include Form Remove Scripts Accept Cookies Show Images Show Referer Rotate13 Base64 Strip Meta Strip Title Session Cookies Contact TGA: info@tga.gov.au | 1800 020 653 | More contact info Translate | Subscribe Therapeutic Goods Administration (TGA) Australian Government Department of Health Main menu Home Safety informationReport a problem or side effectReporting adverse events involving medicines, vaccines or medical devices Report an issue with packaging or storage of a medicine AEMS guidance for health professionals AEMS guidance for sponsors Help us promote adverse event reporting: promotional resources kit AlertsCurrent year alerts All alerts RecallsAbout Australian recall actions Recall actions database Uniform recall procedure Prescription opioids Medicine shortages Early warning systemMonitoring communications About the Early Warning System Early Warning System: consumer questions and answers Early Warning System: health professional questions and answers Black Triangle SchemeBlack Triangle Scheme: Information for sponsors Safety information & educationMedicines safety Medical devices safety Database of Adverse Event Notifications (DAEN) COVID-19 COVID-19 vaccinesCOVID-19 vaccine approval process COVID-19 vaccines undergoing evaluation Provisional registrations COVID-19 vaccine safety monitoring and reporting News and updates COVID-19 vaccine advertising and import compliance Information for consumers and health professionals Information for sponsors (industry) International collaboration COVID-19 treatmentsCOVID-19 treatments: Provisional determinations COVID-19 treatments: Provisional registrations COVID-19 treatments: Treatments undergoing evaluation COVID-19 treatments: Advertising compliance COVID-19 treatments: Information for consumers and health professionals COVID-19 treatments: Information for sponsors (industry) COVID-19 testsHow testing works for COVID-19 COVID-19 point-of-care tests COVID-19 rapid antigen self-tests COVID-19 rapid antigen tests - information for manufacturers and sponsors COVID-19 testing in Australia - information for health professionals Advertising COVID-19 rapid antigen point-of-care tests and self-tests (home use tests) Post market review of COVID-19 point-of-care tests ConsumersReport a problem or side effectReporting adverse events involving medicines, vaccines or medical devices Travelling with medicines and medical devicesLeaving Australia Entering Australia Helpful links for travellers Buying medicines and medical devices onlineCounterfeit medicines and devices Can I import it?Personal importation scheme Medicinal cannabis: importation and the traveller's exemption MedicinesHow we regulate medicines Prescription medicines Complementary medicines Over-the-counter (OTC) medicines Vaccines What's on my medicine label? 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Webinar presentation: Nicotine vaping products, the UK smoking cessation experience 15 November 2021 Webinar presentation on Practical and clinical experience in the practice of smoking cessation treatments in the UK Consultation on potential regulatory options for 'export only' biologicals 15 November 2021 The TGA is conducting a public consultation on potential options for the regulation of biologicals manufactured in Australia for export only (and not for supply in Australia). Closing date: 20 December 2021 Performance Online Services Pty Ltd fined $53,280 for alleged breaches concerning counterfeit erectile dysfunction medicines 15 November 2021 The TGA has issued four infringement notices, totalling $53,280, for the alleged export, supply and advertising of counterfeit erectile dysfunction (ED) medicines in breach of the Therapeutic Goods Act 1989. VeraSeal 12 November 2021 TGA decision: VeraSeal (human fibrinogen/ human thrombin) is approved to treat hemostasis. Adverse event reporting 12 November 2021 Amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 will alter sponsor requirements device adverse event reporting Medical device incident reporting (MDIR) guide 12 November 2021 Guidance document updated to include final report and additional information requirements following amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 Webinar presentation: The role of a UDI Issuing Agency, 21 September 2021 12 November 2021 UDI Webinar No. 4 - recording now available Information for medical practitioners on pending up-classification of surgical mesh devices 11 November 2021 The Therapeutic Goods (Medical Devices) Regulations 2002 have been amended to broaden the transition arrangements for surgical mesh Medical devices reforms: Enhancements to post-market monitoring 11 November 2021 Update on Medical Devices Reforms projects Prescription medicines: registration of new generic medicines and biosimilar medicines 11 November 2021 19 medicine registrations added Prescription medicines: registration of new chemical entities in Australia 11 November 2021 10 medicine registrations added Prescription medicines: new or extended uses, or new combinations of registered medicines 11 November 2021 16 medicine registrations added Reclassification of medical devices that are substances introduced into the human body via a body orifice or applied to the skin 11 November 2021 Guidance to assist sponsors of medical devices that are substances for introduction into the body with meeting their obligations Moderna's COVID-19 vaccine (SPIKEVAX) - provisional determination granted for proposed use in children and booster shot for adults under evaluation 10 November 2021 The TGA has granted a provisional determination to Moderna Australia Pty Ltd in relation to its COVID-19 vaccine, SPIKEVAX. TGA grants provisional determination to AstraZeneca Pty Ltd for COVID-19 preventative treatment, tixagevimab and cilgavimab (EVUSHELD) 9 November 2021 On 4 November 2021 the TGA granted provisional determination to AstraZeneca Pty Ltd in relation to the COVID-19 treatment tixagevimab and cilgavimab (EVUSHELD). Implementation of decisions and actions following the review of chemical scheduling in relation to cosmetic and fragrance ingredients 9 November 2021 Update on the targeted consultation: Implementation of the review of chemical scheduling in relation to cosmetic and fragrance ingredients Unique Device Identification Webinar #6 - 2021 Wrap-up and Q & A 9 November 2021 Final UDI Webinar for 2021 Webinar #6 Medicinal cannabis - Changes to Special Access Scheme (SAS) and Authorised Prescriber applications 9 November 2021 Webinar for Health prescribers regarding changes to SAS applications for medicinal cannabis Medicinal cannabis - Changes to sponsor requirements for supplying unapproved medicinal cannabis products in Australia 9 November 2021 This webinar will guide you through your requirements as a sponsor of an unapproved medicinal cannabis product. Nitrosamine impurities 9 November 2021 TGA investigation – potential contamination of medicines with nitrosamine impurities Nitrosamine impurities in medicines - Information for sponsors and manufacturers 9 November 2021 TGA is working with international regulators and sponsors to investigate and address nitrosamine impurities in medicines. Software for use with COVID-19 rapid antigen self-tests 8 November 2021 Clarification of when software is and is not a medical device and additional scenario added. COVID-19 tests 8 November 2021 A new hub for COVID-19 tests, including rapid antigen, point-of-care and self-tests Melbourne-based individual fined $7,992 for alleged unlawful importation of nicotine vaping products 5 November 2021 The TGA has issued three infringement notices, totalling $7,992, to a Melbourne-based individual for alleged importation breaches involving nicotine vaping products. Supply and wholesaling of medicinal cannabis products (MCP) 5 November 2021 The guidance sets out the regulatory requirements for importing, manufacturing and supplying finished medicinal cannabis products. RV Global Ecommerce Pty Ltd fined $39,960 for alleged unlawful advertising of nicotine vaping products 5 November 2021 The TGA has issued three infringement notices totalling $39,960 to Sydney-based company RV Global Ecommerce Pty Ltd for alleged unlawful advertising of nicotine vaping products. Medical devices reforms: Personalised medical devices 5 November 2021 Guidance updated to reflect recent regulatory refinements to personalised medical devices. Custom-made medical devices 4 November 2021 The annual reporting form for custom-made medical devices is now available. Webinar presentation: Pharmacovigilance – a regulator's perspective 4 November 2021 This presentation delivered on behalf of the TGA to the students at the University Technology of Sydney as part of the Master of Pharmacy course Prescription medicines: applications under evaluation 4 November 2021 Updated list of applications for new medicines or new uses for existing medicines that are currently under evaluation by the TGA S.W.A.G II Platinum 33K 4 November 2021 S.W.A.G II Platinum 33K products pose a serious risk to your health and should not be taken. Panther Power Platinum 11000 4 November 2021 Panther Power Platinum 11000 capsules pose a serious risk to your health and should not be taken. 777K products 3 November 2021 777K products pose a serious risk to your health and should not be taken. One Night Love tablets 3 November 2021 One Night Love tablets pose a serious risk to your health and should not be taken. ACV meeting statement, meeting 24, 26 August 2021 3 November 2021 Advisory Committee on Vaccines meeting statement ACV meeting statement, meeting 23, 30 July 2021 3 November 2021 Advisory Committee on Vaccines meeting statement TGA warns consumers of counterfeit nicotine vaping products 2 November 2021 The TGA is warning consumers to be aware of counterfeit nicotine vaping products advertised and sold online. AusPAR: Casirivimab/imdevimab 2 November 2021 Australian Public Assessment Report for Casirivimab/imdevimab COVID-19 rapid antigen self-tests (for home use) 1 November 2021 From November 1, Australians are able to test themselves for COVID-19 at home. AusPAR: BNT162b2 (mRNA) 1 November 2021 Australian Public Assessment Report for BNT162b2 (mRNA) TGA recognises two more COVID-19 vaccines not registered in Australia but used widely internationally 1 November 2021 The TGA determined that Covaxin (manufactured by Bharat Biotech, India) and BBIBP-CorV (manufactured by Sinopharm, China) vaccines would be 'recognised' for the purpose of establishing a traveller's vaccination status. GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic 1 November 2021 Update to GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic. Last month's news & updates The Therapeutic Goods Administration is part of the Health Products Regulation Group
Changes to Special Access Scheme and Authorised Prescriber applications
19 medicine registrations added
16 medicine registrations added
A new hub for COVID-19 tests, including rapid antigen, point-of-care and self-tests
Last month's news & updates
The Therapeutic Goods Administration is part of the Health Products Regulation Group