Articles

The GMP Clearance SID now contains additional data as well as progress information on the Compliance Verification (CV) backlog reduction strategy.

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.

Information on the completion of automatic extensions for Good Manufacturing Practice (GMP) clearances and next steps.

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

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

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.

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.

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.