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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 International COVID-19 vaccines recognised by Australia COVID-19 treatmentsCOVID-19 treatment: Celltrion Healthcare Australia Pty Ltd, regdanvimab (REGKIRONA) COVID-19 treatment: Roche Products Pty Ltd, tocilizumab (ACTEMRA) COVID-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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Regulator Performance Framework: Self-assessment Report July 2020 - June 2021 23 December 2021 The 2020-21 TGA Regulator Performance Framework Self-assessment (KPI) Report has now been published Database of section 19A approvals to import and supply medicines to address medicine shortages 23 December 2021 Section 19A database has been updated to include new approvals Database of TGA listed medicine compliance review results 22 December 2021 The TGA has published the outcomes of 13 listed medicine compliance reviews and is seeking feedback on how information is presented. Sunscreens - ensuring products are effective and safe for the 2021-22 summer 22 December 2021 The TGA regulates sunscreen products to ensure they meet the high standards for quality, safety and effectiveness set by the Australian regulatory guidelines for sunscreens. 'Banana Boat' Sunscreen Sprays SPF 50+ (aerosol sunscreen) 22 December 2021 Recall - Possible presence of benzene Testing for benzene in aerosol sunscreen products being supplied in Australia 22 December 2021 In consultation with the TGA, Edgewell has taken a precautionary approach and commenced a recall of all batches of these three products from the Australian market. TGA stakeholder survey 2021 22 December 2021 Results report for the 2021 TGA stakeholder survey Apache Log4j - Cybersecurity vulnerabilities 22 December 2021 Cybersecurity vulnerability from Apache Log4j COVID-19 rapid antigen self-tests that are approved in Australia 22 December 2021 A list of self-tests that are approved in Australia. Updated user guide now avaialable for V-Chek COVID-19 Antigen Saliva Test. SA individual fined $7,992 for alleged unlawful advertising of medicinal cannabis 22 December 2021 The TGA has issued three infringement notices, totalling $7,992, to an individual from South Australia for allegedly advertising medicinal cannabis in breach of the Therapeutic Goods Act 1989 . Shortages of tocilizumab (Actemra) medicines 22 December 2021 The TGA published an Actemra (tocilizumab) shortage - consumer information sheet produced by Pain Australia Tocilizumab (Actemra) shortage: Supply improving 22 December 2021 Roche Australia have advised that availability of tocilizumab (Actemra) in Australia is improving but supply disruptions to some tocilizumab products will continue beyond January 2022. Tocilizumab (Actemra) Serious Scarcity Substitution Instrument 21 December 2021 Extension of Serious Scarcity Substitution Instrument for tocilizumab The ability of COVID-19 tests to detect emerging genetic variants of SARS-CoV-2 21 December 2021 The post-market review of COVID-19 test kits now includes the Omicron variant. Rick's Hemp Oil Full Spectrum Hemp Supplement 500 mg 21 December 2021 Rick's Hemp Oil Full Spectrum Hemp Supplement 500 mg poses a serious risk to your health and should not be taken. Therapeutic Goods Advertising Consultative Committee, 6 December 2021 21 December 2021 A meeting of the TGACC was held 6 December 2021. The Communique has now been published. TGA operations over the holiday period 2021-22 20 December 2021 The TGA will have limited operations from Friday 24 December 2021 until Tuesday 4 January 2022. Consultation: Proposed amendments to the Poisons Standard - ACCS, ACMS and joint ACCS/ACMS meetings, March 2022 20 December 2021 Proposed amendments to the Poisons Standard. Closing date: 31 January 2022 Notice of final decisions to amend (or not amend) the current Poisons Standard - ACMS #34, Joint ACMS-ACCS #28, ACCS #31 20 December 2021 This web publication constitutes a notice for the purposes of regulation 42ZCZS of the Therapeutic Goods Regulations 1990 (the Regulations … TGA grants provisional determination to Vaxine Pty Ltd for its COVID-19 recombinant protein vaccine 20 December 2021 The TGA granted provisional determination to Vaxine Pty Ltd in relation to their COVID-19 vaccine, Recombinant CoV-2-S-ΔTM protein with Advax-CpG55.2. Disinfectants: FAQ for new sponsors 20 December 2021 Answers to frequently asked questions in relation to the supply of disinfectant products Guidance on the regulation of listed disinfectants in Australia 20 December 2021 On 1 December 2021, regulatory amendments were made regarding claims of residual activity for listed disinfectants in Australia Essential Principles - consent for noncompliance 17 December 2021 New features added to the consent application form on TBS portal. Commcare (WA) Pty Ltd (St Francis Pharmacy) fined $39,960 for alleged advertising breaches relating to medicinal cannabis 17 December 2021 The TGA has issued three infringement notices totalling $39,960 for alleged unlawful advertising of medicinal cannabis in breach of the Therapeutic Goods Act 1989. Philips recall action for CPAP, Bi-Level PAP devices and mechanical ventilators 16 December 2021 Device repair/replacement program - progress update Consultation: Proposed changes to the Permissible Ingredients Determination: Low-negligible risk changes 2021-22 15 December 2021 The outcome of the Listed medicines ingredient low-negligible risk changes 2021-22 have been published Notice of final decisions to amend (or not amend) the current Poisons Standard in relation to Psilocybin and MDMA 15 December 2021 Final decisions on proposed amendments to the Poisons Standard relating to MDMA and psilocybin Koselugo 15 December 2021 TGA decision: Koselugo (selumetinib) is approved to treat paediatric patients aged 2 years and above, with neurofibromatosis type 1 (NF1) COVID-19 test kits included in the ARTG for legal supply in Australia 15 December 2021 A list of tests approved for inclusion in the Australian Register of Therapeutic Goods (ARTG) Ceftriaxone and risk of hepatitis and encephalopathy 15 December 2021 Medicines Safety Update - Information for health professionals Public submissions on scheduling matters referred to the ACCS #31 meeting held in June 2021 15 December 2021 Public submissions made in response to the public consultation on proposed amendments to the Poisons Standard - June 2021 ACCS meeting Public submissions on scheduling of sodium nitrite referred to the Joint ACMS-ACCS #28 meeting held in June 2021 15 December 2021 Public submissions made in response to the public consultation on proposed amendments to the Poisons Standard - June 2021 Joint ACMS-ACCS meeting Public submissions on scheduling of oral contraceptives referred to the ACMS #34 meeting held in June 2021 15 December 2021 Public submissions made in response to the public consultation on proposed amendments to the Poisons Standard - June 2021 ACMS meeting Public submissions on scheduling matters referred to the ACMS #34 meeting held in June 2021 15 December 2021 Public submissions made in response to the public consultation on proposed amendments to the Poisons Standard - June 2021 ACMS meeting Public submissions on scheduling matters (hand sanitisers) referred to the Joint ACMS-ACCS #28 meeting held in June 2021 15 December 2021 Public submissions made in response to the public consultation on proposed amendments to the Poisons Standard - June 2021 Joint ACMS-ACCS meeting Access Consortium statement on COVID-19 medicines 14 December 2021 Vaccines have played a critical role in fighting the COVID-19 pandemic TGA warns about imports of ivermectin 14 December 2021 TGA has tested a number of imported products labelled as ivermectin and found that they are counterfeit Ngenla 13 December 2021 TGA decision: Ngenla (somatrogon) is approved to treat paediatric growth disturbance Consultation: Compounded medicines and good manufacturing practice (GMP) 13 December 2021 Outcomes and next steps AusPAR: Normal immunoglobulin (human) 13 December 2021 Australian Public Assessment Report for Normal immunoglobulin (human) AusPAR: Tozinameran (mRNA Covid 19 vaccine) 13 December 2021 Australian Public Assessment Report for Tozinameran (mRNA Covid 19 vaccine) Prescription medicines: registration of new chemical entities in Australia 10 December 2021 10 medicine registrations added Prescription medicines: new or extended uses, or new combinations of registered medicines 10 December 2021 4 medicine registrations added Prescription medicines: registration of new generic medicines and biosimilar medicines 10 December 2021 8 medicine registrations added Prescription medicines: applications under evaluation 10 December 2021 Updated list of applications for new medicines or new uses for existing medicines that are currently under evaluation by the TGA Therapeutic Goods (Six Monthly Report Form - Sponsor) Approval 2021 10 December 2021 This is the new the legislative instrument, Therapeutic Goods (Six Monthly Report Form - Sponsor) Approval 2021 to be published on the TGA website. It is for the Six monthly report – supply of unapproved therapeutic goods by a sponsor. Software-based medical devices FAQs 9 December 2021 Frequently asked questions regarding the regulatory approach of the TGA for software based medical devices AusPAR: Elasomeran (mRNA-1273) 9 December 2021 Australian Public Assessment Report for Elasomeran (mRNA-1273) Kerendia 9 December 2021 Australian prescription medicine decision summary AusPAR: Pegvaliase 8 December 2021 Australian Public Assessment Report for Pegvaliase Consultation on Extemporaneous Compounding of Emergency Medicines 8 December 2021 The TGA is seeking feedback on a proposal to improve patient access to critical medicines in acute-care settings. Closing date: 7 February 2022 TGA approves booster doses of the Moderna COVID-19 vaccine, SPIKEVAX 8 December 2021 The TGA has provisionally approved a booster dose of the Moderna COVID-19 vaccine, SPIKEVAX, for individuals 18 years and older. Large numbers of illegal nicotine vaping products seized in a joint TGA-ACT Health operation 7 December 2021 Dangerous and prohibited ingredients were found in two out of every three nicotine vaping products tested by the TGA, following a joint operation conducted by ACT Health and the TGA in response to community tip-offs. Rifampicin 7 December 2021 Safety advisory - contamination of rifampicin medicines with low levels of nitrosamine impurity. AusPAR: Regdanvimab 7 December 2021 Australian Public Assessment Report for Regdanvimab Nextstellis 6 December 2021 TGA decision: Nextstellis (estetrol monohydrate and drospirenone) is approved for use by women of reproductive potential to prevent pregnancy. Regkirona 6 December 2021 Australian prescription medicine decision summary TGA Provisional Approval of Celltrion Healthcare Australia Pty Ltd COVID-19 treatment, regdanvimab (REGKIRONA) 6 December 2021 TGA grants provisional approval to Celltrion Healthcare Australia Pty Ltd for COVID-19 treatment, regdanvimab (REGKIRONA) New ARTG Search tool available for testing 6 December 2021 The TGA have developed a new tool to search the Australian Register of Therapeutic Goods (ARTG). The trial (beta) version of the new tool … Pfizer's COVID-19 vaccine (COMIRNATY) provisionally approved for use in individuals 5 years and over 5 December 2021 The TGA has provisionally approved the Pfizer Australia Pty Ltd COVID-19 vaccine, COMIRNATY, for use in individuals 5 years and older. Oxymed Australia Pty Ltd and director Malcolm Hooper ordered to pay $3 million for unlawful advertising of hyperbaric oxygen therapy devices 3 December 2021 Outcomes of the court action against Oxymed Australia Pty Ltd New Therapeutic Goods Advertising Code 1 January 2022 3 December 2021 A new Therapeutic Goods Advertising Code has been made commencing 1 January 2022, with transition period AusPAR: Adalimumab 3 December 2021 Australian Public Assessment Report for Adalimumab AusPAR: Trientine dihydrochloride 2 December 2021 Australian Public Assessment Report for Trientine dihydrochloride TGA Provisional Approval of Roche Products Pty Ltd COVID-19 treatment, tocilizumab (ACTEMRA) 1 December 2021 On 1 December 2021, the TGA granted provisional approval to Roche Products Pty Ltd for the use of tocilizumab (ACTEMRA) for the treatment of COVID-19. NSW company KL4 Pty Ltd (Medcure) fined $106,560 for alleged unlawful importation of Ayurvedic medicines 1 December 2021 The TGA has issued eight infringement notices totalling $106,560 to KL4 Pty Ltd (trading as Medcure), for the alleged importation of Ayurvedic medicines in breach of the Therapeutic Goods Act 1989 Nexviazyme 1 December 2021 TGA decision: Nexviazyme (avalglucosidase alfa) is approved to treat Pompe disease (acid α-glucosidase deficiency) Medical device patient information leaflets and implant cards 1 December 2021 Updated guidance Suspending, revoking and TGA initiated variation of conditions of a manufacturing licence 1 December 2021 As part of the revised GMP fees and charges, this information has been updated to reflect changes in TBS Requesting variations to your manufacturing licence 1 December 2021 As part of the revised GMP fees and charges, this information has been updated to reflect changes in TBS Australian manufacturing licences and overseas GMP certification 1 December 2021 As part of the revised GMP fees and charges, this information has been updated to reflect changes in TBS Last month's news & updates The Therapeutic Goods Administration is part of the Health Products Regulation Group
Section 19A database has been updated to include new approvals
The post-market review of COVID-19 test kits now includes the Omicron variant.
4 medicine registrations added
8 medicine registrations added
Last month's news & updates
The Therapeutic Goods Administration is part of the Health Products Regulation Group