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.
External link for Therapeutic Goods Administration
Canberra, AU
Many side effects can be prevented by taking medicines as instructed. Ask your healthcare professional these 5 questions to help you make informed decisions and raise awareness of preventing side effects. Report side effects here: https://aems.tga.gov.au/
All medicines can cause side effects. You can help prevent them by taking your medicines as instructed. Remember to take your medicines in the right dose, at the right time, and in the right way. If you think you’re experiencing a side effect, talk to your healthcare professional and report it here: https://aems.tga.gov.au/
#MedSafetyWeek starts today! We’re joining forces with medicine regulators around the world to help spread the word about preventing and reporting side effects from medicines. If you experience a side effect, you can report it to us here: https://aems.tga.gov.au/
Terms such as 'natural', 'naturally derived', 'sourced from nature' and 'all natural' are subject to regulation when advertising therapeutic goods. The Therapeutic Goods Advertising Code prohibits claims from being misleading and requires claims to be truthful, valid, accurate and substantiated. Head to our website for guidance on how advertisers can use these terms without misleading consumers: https://lnkd.in/gRvsw3_W
In a significant move against the illicit vaping market, the TGA has played a vital role in joint enforcement activity with Victoria Police, resulting in the seizure of 200,000 vapes, worth more than $8 million, from a warehouse in Box Hill South Victoria on 24 October 2024. This latest operation, which involved officers from the TGA, Victoria Police and the Victorian Department of Health, supports the Australian Government’s reforms to vaping goods under the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024. The Act restricts the sale of vapes to Australian pharmacies, prohibiting their sale in retail outlets like tobacconists and convenience stores and introduces strict penalties for non-compliance with the law. Read more: https://lnkd.in/g_A9TTtc
The GMP Forum is only 3 weeks away! Join us at the Melbourne Convention and Exhibition Centre on 19-20 November, and speak to our experts on trending topics, TGA inspection trends, and other key reforms underway in GMP Clearance and Recalls. Tickets are still available so register now 👉 https://lnkd.in/dUAPRJUi
We regulate medical devices that are imported into and supplied in Australia. Unless a specific exemption applies, medical devices must be included on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia. If you’re a health professional wanting to import and supply a medical device, visit our website for more information: https://lnkd.in/g7v_9-cd
⚠️ Shingrix vaccine and very rare risk of Guillain-Barré Syndrome⚠️ We have received Australian reports of Guillain-Barré Syndrome (GBS) following Shingrix vaccination. After investigating this issue and seeking advice from an expert panel, the Product Information (PI) and Consumer Medicine Information (CMI) documents for Shingrix were updated. These changes reflect the new reporting data, recognising that GBS is a very rare adverse event. Health professionals should be aware of GBS cases following vaccination with Shingrix. Patients should be warned of this possible but very rare risk and encouraged to seek medical attention if they experience symptoms, as early medical care can reduce severity and improve outcomes. Those with a history of GBS not associated with Shingrix should discuss the risks and benefits of receiving Shingrix with a health professional. We continue to monitor adverse events associated with Shingrix and encourage health professionals to report suspected cases of GBS and other neuroinflammatory conditions after vaccination. Visit our website for more information: https://lnkd.in/gVpQ9EAm
⚠️Safety advisory - Continuing imports of counterfeit ivermectin⚠️ We are continuing to see imports of counterfeit ivermectin and advise consumers to exercise extreme caution when purchasing medicines from unknown overseas websites. We have tested 6 imported, unregistered ivermectin products and found they are counterfeit. Laboratory analysis confirmed that the following products contain less than the stated 12mg of the active pharmaceutical ingredient, ivermectin: Iversun-12, Covimectin-12, Iverheal-12, Iverhuman-12, Ivetab-12 and Iverguard-12. These products were purchased online from an overseas website. We remind consumers that Ivermectin is a prescription-only (schedule 4) medicine in Australia. Knowingly importing, supplying and/or giving away counterfeit therapeutic goods is illegal and poses a significant public health and safety risk. Read more: https://lnkd.in/gbikF8YD
⚠️Safety advisory - African Vigorous Max Strength ⚠️ African Vigorous Max Strength poses a serious risk to your health and should not be taken. We have tested a product labelled African Vigorous Max Strength and found that it contains the undeclared substance sildenafil. Sildenafil may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol or heart disease are often prescribed nitrates. Sildenafil taken in combination with other medications can cause serious side effects. Consumers should stop using African Vigorous Max Strength and take any remaining product to your local pharmacy for safe disposal. If you have any concerns arising from your use of this product, consult your healthcare practitioner. Read more: https://lnkd.in/gr6j9dye