Articles

On 17 December 2025, the TGA made the decision to approve the registration of lenacapavir (YEYTUO).

We have updated the rules for lawfully handling vaping products in Australia. These changes make it clearer for businesses that need to lawfully possess and supply vaping goods as part of their operations.

The Prescription Medicines in Pregnancy database has been updated to include new entries.

We’re seeking information from people who use or recommend digital mental health tools, as part of a review into how these software-based products should be regulated in Australia.

We will implement process enhancements to the Prescription Medicines Minor Variation (PMMV) form by 31 January 2026.

We've updated the Listed Medicine Compliance Reports database with the results of compliance reviews covering 19 listed medicines

Some medical devices could be affected by the end of support for the Microsoft Windows 10 operating system.

This joint statement from the Head of the TGA and Australia’s Chief Medical Officer (CMO), provides you with clear, evidence-informed advice about vaccine safety.

The International Medical Device Regulators Forum (IMDRF) Software as a Medical Device (SaMD) Working Group has published the draft Essential Principles and Content of Predetermined Change Control Plans document for public consultation.

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

We have made changes to our website to make finding information easier. These improvements are based on your feedback.

We’re pleased to announce that improvements for industry users will roll out by the end of October.

There is growing interest in using software and artificial intelligence (AI) in healthcare settings, including where it is used to support people with mental health conditions.

The GMP Guidelines on Chapter 1 - Pharmaceutical Quality System are being updated to reflect contemporary Quality Risk Management principles and further improve how Product Quality reviews are performed.

This Legislation Amendment makes changes to the way testing of goods is conducted under the Therapeutic Goods Regulations 1990.

We've updated the Listed Medicine Compliance Reports database with the results of compliance reviews covering 18 listed medicines

There has been an increase in Australians purchasing melatonin products from online stores, particularly for use in children. These products are often sold as gummies but are also available as tablets or capsules marketed as dietary supplements.

We initiated targeted compliance reviews of selected listed medicines containing Lysine Hydrochloride to verify whether sponsors had appropriate evidence to support their cold sore-related claims.

On 23 September 2025 the TGA made the decision to approve the registration of the lecanemab (LEQEMBI).

A review of the GMP Clearance backlog reduction strategies that have been implemented and ongoing monitoring and reporting communication.

As per our previous statement on 21 August 2025, the TGA is currently investigating a CHOICE report on Sunscreen SPF testing. This update provides information for consumers.

The TGA is currently investigating the CHOICE report on Sunscreen SPF testing, as per our previous statement on 21 August 2025. This update outlines the steps that sunscreen sponsors should take if they identify a problem with their product.

Adoption of International Scientific Guidelines

We have published a list of medical devices in the ARTG that incorporate artificial intelligence (AI) or machine learning (ML) technologies.

Know how we manage compliance of AI and software products that meet the definition of a medical device.