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-19COVID-19 rapid antigen self-tests COVID-19 treatmentsCOVID-19 treatment: Roche Products Pty Ltd, casirivimab + imdevimab (RONAPREVE) COVID-19 treatments: Provisional determinations Labels for COVID-19 treatments 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 vaccinesCOVID-19 vaccine approval process 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 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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Information for medical practitioners on pending up-classification of surgical mesh devices 20 October 2021 Advice for health professionals on possible supply disruption of surgical mesh devices after 1 December 2021 Brukinsa 20 October 2021 Australian prescription medicine decision summary Melbourne-based individual fined $18,648 for alleged unlawful advertising of nicotine vaping products 20 October 2021 The TGA has issued seven infringement notices totalling $18,648 to a Melbourne-based individual, for alleged unlawful advertising of nicotine vaping products COVID-19 rapid antigen self-tests that are approved in Australia 19 October 2021 A list of self-tests that are approved in Australia Discussion paper on potential for mandatory reporting of medical device adverse events by healthcare facilities in Australia 19 October 2021 Stakeholders are invited to review the discussion paper and provide their feedback using the online survey. Closing date: 13 December 2021 Public submissions on scheduling matters referred to the ACMS #33, ACCS #30 and Joint ACMS-ACCS #27 meetings held in March 2021 19 October 2021 Public submissions made in response to the public consultation on proposed amendments to the Poisons Standard - March 2021 ACMS/ACCS meetings Webinar presentation: Nicotine vaping products, the NZ smoking cessation experience 19 October 2021 The role nicotine vaping products can play in a person's journey to quit Enhertu 18 October 2021 Australian prescription medicine decision summary Submissions received: Proposed refinements to the requirements for medical device patient information materials 18 October 2021 Submissions published and summarised as part of a consultation on patient information materials. TGA Provisional Approval of Roche Products Pty Ltd COVID-19 treatment, casirivimab + imdevimab (RONAPREVE) 18 October 2021 The TGA has provisionally approved the use of the Roche Products Pty Ltd combination therapy, casirivimab + imdevimab (RONAPREVE), for the treatment and prevention of COVID-19 in specific target populations. Brukinsa 15 October 2021 Australian prescription medicine decision summary Webinar: Consent to supply medical devices that are non-compliant with the Essential Principles (EPs) 15 October 2021 This webinar will guide you through the new online form to request TGA approval to supply a medical device that is non-compliant with the EPs. Webinar: Non-compliant patient information material 15 October 2021 This webinar will guide you through the new online form to request TGA approval to supply non-compliant patient information materials. Essential Principles - consent for noncompliance 14 October 2021 New online applications forms for consent to supply medical devices that are non-compliant with the Essential Principles are now available Shortages of tocilizumab (Actemra) medicines 14 October 2021 The TGA published an Actemra (tocilizumab) shortage - consumer information sheet produced by Pain Australia Provisional determination granted to Pfizer's COVID-19 vaccine (COMIRNATY) - proposed for use in children 5-11 years of age 13 October 2021 The TGA granted provisional determination to Pfizer Australia Pty Ltd in relation to the COVID-19 Vaccine, COMIRNATY for use in children aged 5 to 11 years. Notice of interim decisions on proposed amendments to the Poisons Standard – Joint ACMS-ACCS #28 – June 2021 13 October 2021 Interim decisions and invitation for further comment. Closing date: 11 November 2021 Notice of interim decisions on proposed amendments to the Poisons Standard – ACCS #31 – June 2021 13 October 2021 Interim decisions and invitation for further comment. Closing date: 11 November 2021 Nicotine Vaping products, the UK smoking cessation experience; practical tips for Australian prescribers 13 October 2021 Webinar - Tips for Australian healthcare practitioners Prescription medicines: registration of new generic medicines and biosimilar medicines 12 October 2021 14 medicine registrations added Inclusions of new biologicals 12 October 2021 2 medicine registrations added Prescription medicines: registration of new chemical entities in Australia 12 October 2021 4 medicine registrations added Prescription medicines: new or extended uses, or new combinations of registered medicines 12 October 2021 10 medicine registrations added Notice of interim decisions on proposed amendments to the Poisons Standard (sodium nitrite) - June 2021 12 October 2021 Interim decisions and invitation for further comment. Closing date: 11 November 2021 Classification of active medical devices (including software-based medical devices) 11 October 2021 Guidance to assist manufacturers of active medical devices, including software-based medical devices, in correctly classifying their devices Pentosan polysulfate sodium and pigmentary maculopathy 11 October 2021 Health professionals are advised that the Product Information for pentosan polysulfate sodium has been updated with a warning about potential pigmentary maculopathy, especially after long-term use. Pentosan polysulfate sodium (Elmiron) 11 October 2021 Safety advisory - Risk of pigmentary maculopathy (changes in the retina of the eye), especially after long-term use AusPAR: Pertuzumab/trastuzumab 11 October 2021 Australian Public Assessment Report for Pertuzumab/trastuzumab Clinical decision support software 11 October 2021 This guidance document provides information about when and how clinical decision support software is regulated in Australia by the TGA. Webinar presentation: The role of a UDI Issuing Agency, 21 September 2021 11 October 2021 UDI No.4 Webinar presentation providing information on the creation of UDIs and the role of an Issuing Agency. ACCM meeting statement, Meeting 28, 15 July 2021 8 October 2021 A meeting statement is now available for the last Advisory Committee on Complementary Medicines meeting Notice of final decisions to amend (or not amend) the current Poisons Standard in relation to nitrous oxide 8 October 2021 Notice of final decision in relation to nitrous oxide - Joint ACMS-ACCS#27 (March 2021) AIVC recommendations for the composition of influenza vaccine for Australia in 2022 7 October 2021 AIVC recommendations for the composition of influenza vaccine for Australia in 2022. Cuprior 7 October 2021 Australian prescription medicine decision summary AusPAR: Eslicarbazepine acetate 7 October 2021 Australian Public Assessment Report for Eslicarbazepine acetate Consultation on Draft Guidance: Assistive Technologies and the Therapeutic Goods (Excluded Goods) Determination 2021 7 October 2021 The consultation period on changes to the assistive technologies exemption has been extended to 22 October 2021. Discontinuation of DILAUDID hydromorphone hydrochloride 1mg/mL oral liquid 7 October 2021 Updated information regarding alternative overseas products approved for supply to address the discontinuation of DILAUDID liquid. Global Medical Device Nomenclature (GMDN) Terms 6 October 2021 GMDN guidance is to assist sponsors and manufacturers when applying for inclusion in the ARTG and selecting a GMDN term. TGA grants provisional determination to Pfizer Australia's COVID-19 treatment PF-07321332 + ritonavir 5 October 2021 On 1 October 2021, the TGA granted provisional determination to Pfizer Australia in relation to a new combination medicine containing PF-07321332 and ritonavir, for the treatment of adult patients with symptomatic, confirmed coronavirus infection. Therapeutic goods advertising compliance: 2020-21 Annual Report 5 October 2021 2020/21 Therapeutic Goods Advertising Compliance Annual Report has been published Advertising therapeutic goods with COVID-19 testing advice 5 October 2021 This fact sheet explains how sponsors and advertisers of therapeutic goods can lawfully include statements about COVID-19 testing in their advertising. Webinar No.5 - The role of a UDI Issuing Agency (Part 2) 5 October 2021 A presentation on the role of a UDI Issuing Agency, including project update with question and answers TGA advice on recognition of COVID-19 vaccines not registered in Australia but used internationally 1 October 2021 The TGA has undertaken an assessment on the protection offered by certain COVID-19 vaccines that are administered in certain countries but not currently registered in Australia. Prescriptions now required to import nicotine vaping products 1 October 2021 Australian consumers now require a valid prescription from any of Australia's 100,000 medical practitioners to import nicotine vaping products, purchased from overseas websites. The Poisons Standard (the SUSMP) 1 October 2021 A new Poisons Standard has been registered on the Federal Register of Legislation as Poisons Standard October 2021. Last month's news & updates The Therapeutic Goods Administration is part of the Health Products Regulation Group
14 medicine registrations added
A presentation on the role of a UDI Issuing Agency, including project update with question and answers
Last month's news & updates
The Therapeutic Goods Administration is part of the Health Products Regulation Group