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We will adopt the 2021 Sunscreen Standard into therapeutic goods legislation. If you're a manufacturer or sponsor, find out what this means for you.

Medicines Safety Update - Information for health professionals

TGA officers executed a search warrant on a Sydney residence linked to an individual suspected of being involved in the manufacture and sale of compounded semaglutide.

The Assessed listed medicine evidence guidelines have been updated, based on feedback, to aid sponsors in preparing their product applications.

The second phase of the Recall Reforms Program is now being implemented. Updated processes will reduce regulatory burden for sponsors while maintaining public safety.

The Minister for Health and Aged Care, the Hon Mark Butler MP, introduced a bill that aims to reduce the widespread availability of vapes by controlling all levels of the supply chain.

Our investigation into the risk of retinal vasculitis and/or retinal occlusive vasculitis in patients being treated with faricimab (Vabysmo) found that stronger warnings regarding this risk were needed in the Product Information (PI) and Consumer Medicine Information (CMI).

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

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

Infringement notices for $82,500 have been issued to Caruso’s Natural Health Pty Ltd, for an alleged failure to hold information or evidence to support therapeutic uses in relation to medicines.

We have updated our guidance on advertising cosmetic injectables to ensure advertising rules are applied consistently across all industries that deal with therapeutic goods.

The TGA and Health Canada have signed a Memorandum of Understanding to further increase collaboration and reliance on Good Manufacturing Practice inspections conducted in countries outside each other's borders.

From 3 June 2024, we will be using a new Good Manufacturing Practice (GMP) guide for medicines, active pharmaceutical ingredients and sunscreens.

Therapeutic goods and records have been seized from a pharmacy in Melbourne. This is part of our investigation into the alleged unlawful manufacture, supply and export of therapeutic goods.

Find out how listed medicine ingredients, and requirements for their use, have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2024.

The targeted consultation is part of a proposal to change the Therapeutic Goods Regulations 1990 to mitigate safety risks in the compounding of GLP-1 RAs.

The TGA has issued 2 infringement notices totalling $37,560 to Queensland-based company Akula Foods Pty Ltd for the alleged unlawful import of unregistered complementary medicines

The TGA has issued 4 infringement notices totalling $75,120 to Liquefy Health Pty Ltd for the alleged unlawful importation and advertising of unapproved complementary medicines.

The TGA has issued 13 infringement notices totalling $42,900 to a New South Wales-based individual for the alleged unlawful advertisement and supply of erectile dysfunction medicines.

Announcement about the launch of the pilot Single Inspection Program, a global approach to Good Manufacturing Practice inspections of third country manufacturers.

Medicines Safety Update - Information for health professionals

The Australian Border Force (ABF) and partners have seized more than five and a half million cigarette sticks and prevented hundreds of thousands of prohibited vapes and drug items from reaching the streets of Sydney.

This instrument is made under regulation 97 of the Therapeutic Goods Regulations 1990.

This instrument is made under Schedule 5A to the Therapeutic Goods Regulations 1990 and Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002.

Medicines Safety Update - Information for health professionals