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The TGA has updated its Advertising therapeutic goods on social media guidance to help advertisers to understand their responsibilities when promoting therapeutic goods via these platforms.

Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2025, which commenced on 19 September 2025.

The TGA has identified a discrepancy between the wording of the ‘POTAS1’ warning statement available in the Code Tables compared to the requirements for potassium chloride and glucosamine sulfate potassium chloride in the Therapeutic Goods (Permissible Ingredients) Determination (the Determination).

We have issued 10 infringement notices, totalling $198,000, to Midnight Health Pty Ltd (Midnight Health) for the alleged unlawful advertising of prescription-only weight-loss medicines.

We have accepted a court-enforceable undertaking from Midnight Health Pty Ltd in relation to the alleged unlawful advertising of prescription-only weight-loss medicines.

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.

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

The GMP Clearance SID now contains additional data as well as progress information on the Compliance Verification (CV) backlog reduction strategy.

We initiated targeted compliance reviews of selected listed medicines containing Vitamin D to verify whether sponsors had appropriate evidence to support their bone strength claims.

Information on the completion of automatic extensions for Good Manufacturing Practice (GMP) clearances and next steps.

Temporary risk-based strategies to expedite the reduction of the GMP Clearance Compliance Verification (CV) backlog commences today.

Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2025, which commenced on 20 June 2025.

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.

A simple post from a respected person can influence the purchasing decisions of many people. If your post meets this definition of advertising, make sure you are complying with the law. Here are some of the important rules to keep in mind when creating content.

In many cases, pharmacists and prescribers are able to provide or prescribe another approved medicine that is on the Australian Register of Therapeutic Goods (ARTG) or they can give a different strength or dosage of the same medicine.

While we encourage health practitioners to prescribe approved therapeutic goods where possible, unapproved therapeutic goods can be accessed in limited circumstances.
In making these joint decisions to use an unapproved therapeutic good, your doctor is required to inform you of the potential benefits and risks.

We have accepted a court-enforceable undertaking from Your Solution Compounding Pharmacy Pty Ltd, regarding advertising of prescription-only compounded medicines for weight-loss.

We have accepted a court-enforceable undertaking from Your Solution Compounding Pharmacy Pty Ltd, regarding advertising of prescription-only compounded medicines for weight-loss.

Update on the progress in reducing the backlog of GMP Clearance Compliance Verification (CV) applications.

Listed medicines indications and requirements for their use have been updated in the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025.

Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2025, which commenced on 1 March 2025

TCMs sold in Australia are carefully regulated to ensure safety and quality.

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

Health professionals and consumers are advised that the oral antihistamine promethazine hydrochloride, sold as Phenergan and other generic brands, should not be used in children under 6 years of age.