Articles

We have issued a notice to Pracmed Healthcare Pty Ltd to cease advertising indications related to weight loss surgery and cognitive function.

There has been a lot of discussion about sunscreen recently. All sunscreens that have a primary purpose of protecting against UV radiation are regulated by the TGA. They must be included in the Australian Register of Therapeutic Goods (ARTG) to be lawfully supplied in Australia

We are advising sponsors, who are intending to register new prescription medicines, of a new way to pursue work-sharing for priority applications.

We've created a new GMP clearance Sponsor Information Dashboard (SID) to provide industry with current information about our processing times, workload and key messages. We have also updated our GMP clearance guidance.

Find out about how GMP clearances for manufacturing sites in Bulgaria can now be assessed via the Mutual Recognition Agreement (MRA) pathway.

Information about GMP clearances issued via the MRA Pathway that expire on 31 December 2023 as well as information on the ongoing use of the GMP clearance questionnaire.

Be alert to new warnings of romosozumab (Evenity) cardiovascular risks for patients with a history of heart attack or stroke. If you're a health professional, read our Medicine safety update.

If you use a Philips Continuous Positive Airway Pressure (CPAP) machine or a Bi-level Positive Airway Pressure (Bi-Level PAP) machine you may be affected by this recall action. Register your machine for repair or replacement to avoid any potential risks.

If you create content, you should know how to protect yourself and your business when it comes to promoting therapeutic goods.

We have alleged that the advertising on the company's website and social media was unlawful because medicinal cannabis products are prescription-only medicines that can't be advertised directly to consumers.

The changes will help address the significant public health issues caused by vaping in Australia, while keeping legitimate patient access to therapeutic vapes.

If you have ever taken medicines, received an implant, had a blood transfusion or been given a vaccine, the TGA regulates those products. Did you know that the TGA also regulates some common products you’ll find in your local supermarket or health store?

We have launched a new search feature in the Adverse Event Management System (AEMS) portal.  As a sponsor, you can access adverse event reports about your medicines and biologicals.

If you're a health professional, get the latest information about medicines with safety related updates to their product information.  

We've worked with the Australian Border Force to keep more than 307,000 units of unlawfully imported medicines and medical devices out of the Australian market.

We have issued 45 infringement notices totalling $742,500 to InstantScripts Pty Ltd for the alleged unlawful advertising of prescription-only medicines.

It's #MedSafetyWeek, a global movement to encourage the reporting of medicine side effects (known as ‘adverse events’). You can join in and help spread the word.

In line with the official end of the COVID-19 emergency response, this will be our last regular COVID-19 Vaccine Safety Report. We will continue safety monitoring of COVID-19 vaccines.

We've granted a labelling exemption for the COVID-19 Vaccine, Pfizer (raxtozinameran), under the current Poisons Standard.

The Federal Court of Australia has ordered Vapor Kings Pty Ltd to pay $4.9 million for unlawfully advertising nicotine vaping products. A company Director was also ordered to pay $100,000 in penalties.

We have issued infringement notices totalling $82,632 to Ovira Pty Ltd, and an individual, for the alleged unlawful advertising of an analgesic TENS system.

Find out how listed medicine ingredients, and requirements for their use, have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2023.

Information about the TGA's safety monitoring of COVID-19 vaccines.

Recent coronial inquiries have highlighted the need for health professionals to be alert to the well documented risk of overdose with baclofen.

‘Haytox’ has not been approved by the TGA or included in the Australian Register of Therapeutic Goods (ARTG).