Articles

Oral preparations containing more than 50 mg but not more than 200 mg per recommended daily dose of vitamin B6 will be rescheduled as Pharmacist Only Medicines from 1 June 2027.

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

The Adverse Event Management System (AEMS) has moved to the cloud, delivering improved system stability and security.

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

We conducted targeted compliance reviews of selected listed medicines using indications related to diarrhoea that are required to display a warning statement

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

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.

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

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

Product warnings across the GLP-1 RA class of medicines have been aligned to ensure consistent information regarding the potential risk of suicidal thoughts or behaviours.

Our investigation into the potential for reduced effectiveness of oral contraception during initiation or dose escalations with Mounjaro (tirzepatide) has found that this association could not be ruled out.

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

The Product Information for denosumab products indicated for the treatment of osteoporosis have been updated to strengthen the existing warning for multiple vertebral fractures following discontinuation or delay of treatment.

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.

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

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.

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

New warnings on hepatotoxicity risk and monitoring recommendations have been added to the Product Information for Veoza (fezolinetant).