Articles

This instrument is made under subsections 19(5AA), 32CM(1A) and 41HC(1A) of the Therapeutic Goods Act 1989.

This instrument is made under the Therapeutic Goods Regulations 1990, the Therapeutic Goods (Medical Devices) Regulations 2002 and the Therapeutic Goods Act 1989.

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

Find out about new requirements for labels of injectable electrolyte medicines and updates to guidance for medicine sponsors.

MRA GMP clearances that are expiring on 31 December 2024 will be automatically extended.

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

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

TGA has made the decision not to register lecanemab (LEQEMBI) for the treatment of patients with Mild Cognitive Impairment (MCI) due to Alzheimer's disease and Mild Alzheimer's dementia (early Alzheimer's disease).

The TGA is updating information for nitrosamine impurities in medicines including acceptable intakes (AI).

Following our Essential Principles presentations on 11-12 September 2024, we have collated questions asked into themes to simplify finding information of relevance to you.

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

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

Find out how listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) which commenced on 27 September 2024.

This instrument is made under the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002.

Two new quality standards, one for MDMA and another for psilocybine, have been published.

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

This instrument is made under regulations 10AC, 10FA and 10HA of the Therapeutic Goods Regulations 1990.

This instrument is made under regulations 10AB, 10F and 10H of the Therapeutic Goods Regulations 1990.

Some changes are rolling out soon to improve your experience using guidance on our website. We’re aiming to make our content clearer, more accessible and easier to navigate.

An updated warning about the risk of sudden cardiovascular death has been added to the Product Information and Consumer Medicine Information documents for azithromycin.

The TGA reminds businesses and media outlets that it is unlawful to publicly advertise prescription-only medicines, including prescription-only weight loss medicines.

We are advising sponsors of updates to the Generic Medicines Work-Sharing Initiative (GMWSI) operational procedures.

Following an extensive internal and external consultation process, we have adopted the following 13 international scientific guidelines.

Information for manufacturers and sponsors regarding a new method for GMP inspections that will be used from 1 July 2024 and the extended validity of TGA issued GMP Certificates.

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