Articles

We have published information to clarify when digital scribes - also referred to as AI scribes or ambient scribes - are regulated as medical devices in Australia.

There has been an increase in the illegal advertising and online sales of nicotine pouches, with many of these products being imported from overseas.

The TGA is updating information for nitrosamine impurities and other nitroso-structure impurities in medicines including acceptable intakes (AI).

We have published our Clarifying and strengthening the regulation of Medical Device Software including Artificial Intelligence (AI) report.

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

The TGA has facilitated the seizure of millions of counterfeit and illegal therapeutic goods as part of a global initiative targeting illegal trade.

Following a number of stakeholder queries, the TGA is providing an updated statement on the PFAS ban. The original statement was published on 27 June 2025.

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

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.

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

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

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.

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

Risk of Guillain-Barre syndrome added to Product Information.

Updated illustrations clarify how to use measuring syringe for oral solutions.

Like all goods available in Australia, therapeutic goods can sometimes experience problems. When this happens, we decide if a ‘market action’ is needed. A market action aims to correct the problem. There are four types of market actions you should be aware of.

Complementary medicines are therapeutic goods that are often derived from traditional medicine practices. They can usually be purchased from supermarkets, health stores and pharmacies without seeing a doctor or pharmacist.
However, just because a medicine is available without a prescription, or claims to be ‘natural’ or ‘healthy’, doesn’t mean it’s safe for you.

While we encourage health practitioners to prescribe approved therapeutic goods where possible, unapproved therapeutic goods can be accessed in limited circumstances.
In making these joint decisions to use an unapproved therapeutic good, your doctor is required to inform you of the potential benefits and risks.

Updated information for nitrosamine impurities in medicines consistent with recent EMA updated information.

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

Updates further highlight potential risks of mood-related changes and sexual disorders.

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

More prominent warnings are being added to the Product Information (PI) and Consumer Medicine Information (CMI) for all oral and injectable (systemic) fluoroquinolones to strengthen existing warnings about serious side effects