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An update about expected increases in the number of medical device incident reports reported to the TGA

We've updated the Listed Medicine Compliance Reports database with the results of compliance reviews covering 51 listed medicines

Temporary risk-based strategies to expedite the reduction of the GMP Clearance Compliance Verification (CV) backlog commences today.

Our second online study is open now.

Australians who rely on medical devices will benefit from new measures introduced by the Australian Government to enhance the identification and management of device-related safety concerns.

Medical devices, including components in the device, primary packaging, instructions for use, and spare parts, will not be affected by the PFAS ban.

We are aware that recent media reports have stated that the TGA estimates that more than 10 million vapes are sold nationally every month on the black market. These reports are incorrect.

Information for health professionals about medicines with safety related updates to their Product Information.

The TGA has accepted a court-enforceable undertaking from The Aussie Gelatin Company Pty Ltd (Aussie Gelatin) in relation to the alleged unlawful manufacture, supply and advertising of therapeutic goods.

We have accepted a court-enforceable undertaking from The Aussie Gelatin Company Pty Ltd (Aussie Gelatin) in relation to the alleged unlawful manufacture, supply and advertising of therapeutic goods.

We have issued an infringement notice of $18,780 to Victorian-based company, Nourishmeorganics Pty Ltd, for the alleged unlawful supply of a therapeutic good not entered in the ARTG.

Information about the indications for the individual products and how to avoid administration errors.

We have commenced proceedings in the Federal Court of Australia against Atlus and its sole director, Mamamia, News Life and Straight Up for advertising medicinal cannabis in alleged contravention of the Therapeutic Goods Act 1989.

Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2025, which commenced on 20 June 2025.

Learn about the strengthened standards for all therapeutic vaping goods for smoking cessation and nicotine dependence.

This statement is an update to provide technical clarification regarding information on laboratory testing and release of information by the TGA. The original statement was published on 12 June 2025.

We are aware of a CHOICE report where a number of sunscreens were found to not meet their claimed Sun Protection Factor (SPF) ratings.

New warnings added of risks during anaesthesia or deep sedation.

The Therapeutic Goods Administration has commenced proceedings in the Federal Court of Australia against Philips Electronics Australia Limited (PEAL) for the alleged unlawful supply of medical devices that did not meet Australian safety and performance requirements.

Temporary risk-based strategies are being introduced to expedite the reduction of the Good Manufacturing Practice (GMP) Clearance Compliance Verification (CV) backlog.

Following a public consultation process , the TGA has adopted the following 19 international scientific guidelines.

Information for health professionals about medicines with safety related updates to their Product Information.

Our Good Manufacturing Practice (GMP) Clearance information resources have been updated with new information for Sponsors

A simple post from a respected person can influence the purchasing decisions of many people. If your post meets this definition of advertising, make sure you are complying with the law. Here are some of the important rules to keep in mind when creating content.

In many cases, pharmacists and prescribers are able to provide or prescribe another approved medicine that is on the Australian Register of Therapeutic Goods (ARTG) or they can give a different strength or dosage of the same medicine.