Therapeutic Goods Administration

We are aware of misinformation in recent media and online reports that claim the COVID-19 mRNA vaccines are contaminated with excessive levels of DNA. This is not the case. These reports are based on studies conducted by a small number of laboratories that have attempted to investigate the amount of DNA in COVID-19 vaccines. While the TGA welcomes and constantly reviews the latest scientific evidence about the safety of vaccines and other biotechnology products, these recent studies fail to apply the required scientific rigor expected in pharmaceutical testing. As such, the results are not robust or reliable, and are creating confusion and concern regarding the safety of vaccines. The TGA reassures the public that all COVID-19 vaccines approved in Australia have been rigorously assessed and meet our high standards for safety, quality, and efficacy. Read more: https://lnkd.in/grPxBq-b

Only therapeutic vaping goods on our list of notified vapes can legally be supplied in Australia. While they’re not assessed by the TGA for quality, safety and efficacy or performance, unapproved vapes must meet certain product standards. We undertake post-market testing of notified vapes to assess compliance with the standards. Pharmacists should check the list to be assured that the goods they stock comply with the current standards. Visit our website for more information: https://lnkd.in/deHwB7E8

There are only 2 weeks to go until the software classification transition period ends. 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

⚠️ Medicine shortages update - Shortage of Metalyse resolved ⚠️ Pharmaceutical company Boehringer-Ingelheim has notified us that the shortage of Metalyse is resolved. It is now available for use in all clinical settings and the conservation methods that have been in place since 2022 are lifted. To support ongoing supply of Metalyse for all service providers, please order quantities based on your current needs and do not stockpile the product. Please consider using any existing stock of other thrombolytic medicines if you plan to transition back to Metalyse. Visit our website for more information: https://lnkd.in/gu5cqGnn

We have published updated information for nitrosamine impurities in medicines consistent with recent EMA updated information. The changes include additional clarification for sponsors and manufacturers of the TGA’s expectations, minor editorial amendments, increases to the acceptable intakes (AI) limit for some nitrosamine impurities and inclusion of recently internationally determined AI limits for numerous nitrosamine impurities in medicines. Sponsors and manufacturers are expected to be familiar with the current AIs for nitrosamine impurities in medicines. Read more: https://lnkd.in/g_vFgsGV

Under the pharmacist only model, pharmacists can supply therapeutic vapes where it’s clinically appropriate to patients who: • are 18 years or over • require a nicotine concentration of 20mg/mL or less • provide informed consent. A consultation with a pharmacist is required, and purchase is subject to certain conditions as well as any state and territory restrictions. Only products on our list of notified vapes can be supplied. Pharmacists must complete a Special Access Scheme (SAS) C notification through our SAS and AP Online System for each supply transaction. Visit our website for more information: https://lnkd.in/deHwB7E8

We have published our response to your questions about our consultation – Medical devices Essential Principles: Part 2 - Proposed changes to align with the European Regulations – to our website with the slides from the presentation. Visit our website for more information: https://lnkd.in/gBwtHA7g

The countdown to the adoption of Annex 1 in Australia has started. Join Matt for this session as he walks you through a roadmap of the adoption process and timelines and how you can best prepare for this important update to the GMP guide. Register online 👉 https://lnkd.in/g4NzCX8U

One of our functions is to monitor and enforce compliance with laws that regulate therapeutic goods in Australia. We safeguard the health of the Australian community through effective and timely regulation of therapeutic goods, which helps ensure the medicines and medical devices that millions of Australians rely on are safe and fit for purpose. To support our compliance programs, we use a combination of monitoring strategies. Learn more about how we approach and manage compliance: https://lnkd.in/g8_eTzEG

Under the prescription model, pharmacists that dispense therapeutic vapes must meet certain regulatory obligations, including: • verifying that it’s appropriate and lawful to supply the vape • only supply products on our list of notified vapes. Pharmacists may dispense vapes with evidence of a prescription and one of the following: • Authorised Prescriber (AP) approval • Special Access Scheme (SAS) B approval • SAS C notification. Pharmacists can use the TGA reference number to check the validity of approvals and notifications through our SAS and AP Online System. Visit our website for more information: https://lnkd.in/deHwB7E8