Therapeutic Goods Administration

📢 Consumers Health Forum of Australia (CHF) is hosting a webinar to break down the changes to vaping regulations and how they will affect consumers as of 1 October 2024. Hear from expert speakers including the TGA’s Mandy Edlington who will step you through the key changes and what they mean for you. Visit the CHF website to register 👉 https://lnkd.in/g4FNtrSi

Two new quality standards, one for MDMA and another for psilocybine, have been published. These standards each specify the minimum quality requirements for both the active pharmaceutical ingredient (API) and finished product. From 6 January 2025, all MDMA and psilocybine API and finished products supplied or manufactured in Australia must comply with the relevant TGO. Read more: https://lnkd.in/gNDrfTyi

📢 This webinar provides information about the TGA’s public consultation on the proposed changes to the Australian Essential Principles and an opportunity for you to ask questions about the consultation paper. The consultation paper seeks feedback on proposed changes to the Essential Principles to align, where appropriate, with changes being implemented in the European General Safety and Performance Requirements. The webinar will run twice, Wednesday 11 September and Thursday 12 September. For more information on the consultation and to register online 👉 https://lnkd.in/eBGRhYPc

New AusPAR for Nelarabine Reach (nelarabine) has been approved to treat patients with relapsing /refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma. Read more: https://lnkd.in/gjcS5Tiq

Businesses that have vaping goods that can no longer be supplied in Australia can surrender them via the TGA’s business surrender scheme. The scheme is available to businesses possessing more than: • 280 vaping devices • 1,800 vaping accessories • 12,000mL of vaping substance. The scheme is available to pharmacy and non-pharmacy retailers, wholesalers, manufacturers, importers, exporters, transport or storage providers. Businesses that wish to participate are reminded that they must notify the TGA before 1 September 2024 by email to [email protected]. Visit our website for more information: https://lnkd.in/gKuMn7nA

⚠️Product Information safety updates⚠️ When new safety information for medicines is identified, we work with the sponsors to update Product Information (PI) to ensure that health professionals and consumers have access to this information. New safety information can be identified through our ongoing safety monitoring activities or uncovered and submitted by sponsors themselves. See our website for more information, including details of safety-related PI updates for August: https://lnkd.in/gQuDdjq7

New AusPAR for Xenpozyme (olipudase alfa) has been approved as an enzyme replacement therapy for the treatment of noncentral nervous system manifestations of acid sphingomyelinase deficiency in paediatric and adult patients with Niemann-Pick disease (types A/B or B). Read more: https://lnkd.in/gUstuzus

Health practitioners can prescribe unapproved products for their patients under the Special Access Scheme (SAS) or as an Authorised Prescriber (AP). See our website for guidance and information on accessing unapproved therapeutic goods under the SAS or as an AP: https://lnkd.in/g9tCK2GW

New AusPAR for Winlevi (clascoterone) cream has been approved to treat acne vulgaris in patients 12 years of age or older. Read more: https://lnkd.in/gmwB728x

If you’ve notified us that your software-based medical device needs to be re-classified, you must either: 1. Submit your TGA Conformity Assessment application 2. Submit your ARTG application This must be done before 1 November 2024. If you’re unsure what to do, you can email [email protected]. Visit our website for more information: https://lnkd.in/gQ-TN9Bi