Articles

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.

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.

In 2025, the Therapeutic Goods (Exempt Monographs) Amendment Determination was introduced under the Therapeutic Goods Act 1989. This amendment updates the 2021 determination to exempt specific labelling requirements in certain pharmacopoeial monographs.

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.

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

Our second online study is open now.

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.

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

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.

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

Risk of Guillain-Barre syndrome added to Product Information.

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

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.