Therapeutic Goods Administration

Thank you for being a part of our online community this year. We wish you a safe and happy festive season! The TGA will have limited operations from Wednesday 25 December 2024 until Thursday 2 January 2025. See our website to find out more about TGA operations over the holiday period: https://lnkd.in/gTNEfAPr

We are providing sponsors with advance notice of the final package of the recall reforms which will be implemented in early March 2025. This includes providing a preview of Australia’s new recall procedure which will be known as the Procedure for Recalls, Product Alerts and Product Corrections (PRAC). The PRAC will: • enhance the transparency, communication and timeliness of recalls, alerts and corrections • introduce new market action terminology, reducing the categories from 8 to 4 • halve the number of steps in the process from 10 to 5 but will not require any major changes to how sponsors approach the process • feature fewer pages with less repetition, clearer information and instructions. Sponsors will continue to follow the Uniform Recall Procedure for Therapeutic Goods (URPTG) until early March 2025, at which time the URPTG will be replaced by the PRAC. We will advise the precise implementation date closer to this time. Read more: https://lnkd.in/g6J8gYa2

⚠️Product defect correction / Implant hazard alert ⚠️ Boston Scientific have advised that a subset of ACCOLADE dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST cardiac resynchronization therapy pacemakers (CRT-Ps) have an increased risk of permanently entering Safety Mode which has limited functionality. The following products have been affected: Affected Model numbers: L311, L331, U225, U226, U228 Product Names: • ACCOLADE DR SL MRI • ACCOLADE DR EL MRI • VISIONIST CRT-P EL • VISIONIST CRT-P EL MRI The affected devices are at risk of permanently entering Safety Mode during telemetry or other normal, higher-power operations. This has been associated with the pacemaker failing to adequately regulate the heart’s rhythm and rate in some patients. Health professionals are advised to: • Monitor patients with affected pacemakers through remote or in-person visits. • When a device is in Safety Mode, you will be directed to contact Boston Scientific via the LATITUDE programmer warning screen and a LATITUDE remote patient management system red alert. • Monitor patients for symptoms indicating device performance problems, such as light-headedness or loss of consciousness. • General prophylactic device replacement is not recommended: unless a patient has a device in the advisory population and are at risk of harm due to non-programmable parameters in Safety Mode. • If monitoring indicates that the device has entered Safety Mode, arrange for the device to be replaced. Timely replacement is recommended to avoid risks associated with time spent in Safety Mode. • Detailed information can be found in the customer letter supplied to clinicians who have implanted this device. Read more: https://lnkd.in/giZ6Zsvg

New AusPAR for Vafseo (vadadustat) has been approved for the treatment of anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis. Read more: https://lnkd.in/gbPY9Pc7

New AusPAR for Elrexfio (elranatamab) has been provisionally approved for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody and have demonstrated disease progression on the last therapy. Read more: https://lnkd.in/g78mqFc6

We have made additional changes to the guidance for Therapeutic Goods Order No. 91 and TGO 92 – Standards for labels of prescription and related medicines and labels of non-prescription medicines. This update relates to labelling for products containing valproic acid and valproate salts. Read more: https://lnkd.in/g_wdQhyc

We have introduced new features to improve the user experience for Guidance on our website. Guidance is now clearer to understand, easier to navigate and more reliable. It’s easier to keep track of changes to Guidance and understand the rules you need to follow. The changes include visual indicators to flag pages that have been recently published or updated, page history and the ability to save guidance pages as a PDF. Find out more and let us know what you think: https://lnkd.in/g627-HV2

Australian Prescriber have recently published an article on our new ‘safety through adverse event reporting: medicines and vaccines’ e-learning module. This interactive online learning supports health professionals in reporting adverse events associated with medicines and vaccines, contributing to the TGA’s ongoing safety monitoring. Participating also counts towards Continual Professional Development (CPD) for health professionals. You can find out more about the e-learning module here: https://lnkd.in/gSfA_nGR And read the article here: https://lnkd.in/gGC7BYhy

A Sunshine Coast tobacconist has been fined $37,560 after the TGA issued it with infringement notices for the alleged unlawful possession of a commercial quantity of vaping goods, as part of the TGA's enforcement activities against illegal vapes. The vaping goods were located when the TGA executed search warrants across multiple businesses on 18 and 19 September 2024 as part of a joint operation with Queensland Health and the Queensland Police Service. Over 4,900 vapes and almost 300 tins of nicotine pouches, in addition to tobacco, were seized during this 2-day operation. The enforcement operations highlight the commitment of both the TGA and Queensland Health to ensuring compliance with the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024, which prohibits retailers such as tobacconists and convenience stores from selling any type of vape. Only Australian pharmacies are permitted to supply vapes. Read more: https://lnkd.in/grAgc6Xq

⚠️Safety advisory - Elemental impurities in traditional Chinese medicines⚠️ Traditional Chinese medicines (TCMs) sold in Australia are carefully regulated to ensure safety and quality. They must meet limits on impurities like lead, arsenic, cadmium, and mercury, which can be absorbed by plants. To protect consumers, the TGA requires TCMs to comply with national and international guidelines that set safe daily limits for these impurities. Sponsors should consider the permissible daily exposure limits for certain elemental impurities, such as heavy metals, in their TCM products. Read more: https://lnkd.in/g7NbSCnJ