Articles

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

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.

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

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 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.

In 2025, the Therapeutic Goods (Exempt Monographs) Amendment Determination was introduced under the Therapeutic Goods Act 1989. This amendment updates the 2021 determination to exempt specific labelling requirements in certain pharmacopoeial monographs.

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.

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.

This instrument is made under subsection 7C(1) of the Therapeutic Goods Act 1989.

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

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.

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

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.

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.