📢 We’re seeking feedback on proposals identified for mitigating risks and leveraging opportunities associated with the use of Artificial Intelligence (AI) models. Your response will inform our upcoming report to government. In the 2024-25 federal budget, the Australian Government provided $39.9 million over 5 years for the development of policy and capability across government to support the safe and responsible adoption and use of AI technology. Several agencies across government, including the Department of Health and Aged Care, are working to address the priority areas of consumer and copyright law, and the use of AI in health and care. As part of this work, the TGA is conducting a review of our legislative framework to clarify and strengthen regulation relating to AI. Have your say using our online survey 👉 https://lnkd.in/gNQfhi-x
Therapeutic Goods Administration
Government Administration
Australia's medicines and medical devices regulator
Über uns
We safeguard and enhance the health of the Australian community through effective and timely regulation of therapeutic goods, including medicines, biologicals and medical devices. Our aim is to ensure therapeutic goods available in Australia are of an acceptable standard. The TGA regulates therapeutic goods through: pre-market assessment; post-market monitoring and enforcement of standards; and licensing of Australian manufacturers and verifying overseas manufacturers' compliance with the same standards as their Australian counterparts.
- Website
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http://www.tga.gov.au
External link for Therapeutic Goods Administration
- Industrie
- Government Administration
- Größe des Unternehmens
- 201-500 Mitarbeiter
- Typ
- Government Agency
Standorte
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Primäre
Wegbeschreibung erhalten
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Wegbeschreibung erhalten
Canberra, AU
Employees at Therapeutic Goods Administration
Aktualisierungen
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We have issued an infringement notice totalling $18,780 to the New South Wales based company Sun Herbal Pty Ltd, for the alleged supply of a complementary medicine that was missing a mandatory warning statement. The medicine included the ingredient Artemisia frigida, which should not be taken by women who are pregnant or likely to become pregnant. However, the label of the medicine did not include the required warning statement advising this, nor did Sun Herbal Pty Ltd have consent to supply the medicine without this warning statement on the label. The medicine has been recalled and is no longer permitted to be supplied. Read more: https://lnkd.in/gAjHxts8
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Therapeutic Goods Administration reposted this
💊 Advertising Therapeutic Goods: "But Everyone Else Does It!" Isn't a Free Pass 🙅🏻 As health professionals, we’re responsible for how we advertise or talk about therapeutic goods—whether it’s explicit or implied. Let’s be honest: keeping up with all the regulations can feel overwhelming. But the truth is, not knowing the rules or seeing others bend them doesn’t excuse us from compliance in the eyes of the Therapeutic Goods Administration. Just like we keep up with clinical knowledge, it’s also our responsibility to understand and follow advertising regulations. Think of it like driving—we need to know the road rules, not just how to operate the car. We wouldn’t cut corners in patient care, and the same goes for advertising obligations. If you’re unsure about the rules, here are some steps you can take: ✔️ Visit the TGA website's Advertising Hub yes& ✔️ Speak with a regulatory affairs consultant ✔️ Call/email the TGA helpdesk for guidance ✔️ Listen to Episode 21 of The Safe Practice Podcast with TGA’s Deputy Secretary Professor Tony Lawler on "The Perils and Pitfalls of Advertising Therapeutic Goods" Podcast link here: https://lnkd.in/g9_antBs Protect yourself and your practice. Stay informed, stay compliant. #TGACompliance #TherapeuticGoods #AdvertisingRules #TheSafePracticePodcast 📌 All content and opinions expressed in this post and on this forum are entirely my own, and do not represent the views of any organisation with which I'm affiliated.
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New AusPAR for Lokelma (sodium zirconium cyclosilicate hydrate) has been approved for the treatment of hyperkalaemia in adult patients. Read more: https://lnkd.in/gmr596YC
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Therapeutic Goods Administration reposted this
📣 Health Professionals: the low-down on endorsements and testimonials for Therapeutic Goods 💊 👉 Whether you’re a current or former health professional, here’s something important to know: you cannot endorse or provide testimonials on any therapeutic goods—either explicitly or by implication. And this covers a lot more than you might think. What does this mean in practice? 🚫 No direct endorsements of therapeutic products. An endorsement is a form of support in which you rely on your education, experience or expertise. 🚫No testimonials or personal anecdotes that suggest a product's effectiveness. This means no describing of positive personal experiences with therapeutic goods. 🚫Tread very carefully with brand ambassador gigs – this includes standing in front of a brand banner or logo for a therapeutic good whilst speaking generically about a health condition. The TGA takes endorsements and testimonials seriously—even subtle endorsements can cross the line. So if you’re chatting about health and wellness, just make sure it doesn’t come off as promoting a product, even unintentionally. If you’re not sure where the line is, either: 💻 Check out the Therapeutic Goods Administration website’s Advertising Hub or 🎧Listen to Episode 21 of The Safe Practice Podcast: "Q&A with the TGA – The Perils and Pitfalls of Advertising Therapeutic Goods" with TGA’s Deputy Secretary Professor Tony Lawler : https://lnkd.in/g5JvnMu5 Staying compliant protects you, the profession, and the trust we’ve earned from our patients. #HealthProfessionals #TGA #TherapeuticGoods #AdvertisingRules #TheSafePracticePodcast 📌 All content and opinions expressed in this post and on this forum are entirely my own, and do not represent the views of any organisation with which I'm affiliated.
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We have published new guidance to assist manufacturers and sponsors to understand the requirements for compliance with the new quality standards for MDMA and psilocybine active pharmaceutical ingredients and finished product. Visit our website for more information: https://lnkd.in/gYQ6N6PM
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Our System for Australian Recall Actions (SARA) database provides information on recalls, product defect corrections and alerts for a range of therapeutic goods. When searching the database, here’s three things you need to enter: 1. Type of product 2. Product name, active ingredient or ARTG number 3. Date range Find out more: https://lnkd.in/gPc3njQ4
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📢 Join Consumers Health Forum of Australia (CHF) and expert speakers, including TGA’s Mandy Edlington, this Thursday 12 September as they break down the changes to vaping regulations as of 1 October 2024. Visit the CHF website to register 👉 https://lnkd.in/g4FNtrSi
Confused about vaping reforms? Join CHF and guest panelist Mandy Edlington from the Therapeutic Goods Administration as we break down the pending changes to vaping regulations that will take effect from 1 October 2024 and how they will impact consumers. Mandy has experience in leading the design and development of legislative and regulatory measures to support the Government’s vaping reforms. Register today to hear her insights https://lnkd.in/g4FNtrSi
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TGA’s Deputy Secretary, Professor Tony Lawler joined Dr Maria Li on The Safe Practice Podcast to talk about the perils and pitfalls for health professionals when advertising therapeutic goods. Listen to it here 👉 https://lnkd.in/g2x_HTiT
🎧 E21: Q&A with the TGA: the Perils and Pitfalls of Advertising Therapeutic Goods. In this must-listen episode, I sit down with Professor Tony Lawler, Deputy Secretary of the Australian Federal Government’s Health Products Regulation Group—home to the Therapeutic Goods Administration (TGA). We dive into the essential obligations that every Australian health professional needs to know when it comes to discussing, representing, and advertising therapeutic goods—whether in their practice, marketing, or online presence. In today’s digital world, where our footprints are permanent, it's crucial to stay compliant with TGA regulations. Tony sheds light on the legislation and regulations that affect us all, and what I learned was nothing short of eye-opening. This is easily one of my favourite episodes to date. If you're an Aussie health professional, this episode is non-negotiable. Listen twice. Share it with your colleagues. We’re all accountable to these rules, and as Tony made clear, ignorance is no excuse for non-compliance. Grab a cuppa (or something stronger) and settle in for 45 minutes of essential, eye-opening content. For more on the TGA’s advertising guidelines, visit the TGA Advertising Hub. **All opinions in this podcast are those of the host and guest, and do not reflect the views of any affiliated organizations. https://lnkd.in/gVCzpWpJ
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Sports supplements can be classified as either a food or a therapeutic good. Find out if your sports supplement is a therapeutic good and should be included in the Australian Register of Therapeutic Goods by using the helpful tool on our website: https://lnkd.in/gbgyjT3Y
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