Articles

We will be initiating targeted compliance reviews of selected listed medicines that are required to display a warning statement

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

This consent is given under sections 14 and 14A of the Therapeutic Goods Act 1989.

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.

We are aware of misinformation that claims the COVID-19 mRNA vaccines are contaminated with excessive levels of DNA. This is not the case.

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.

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.

Find out how listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2024, which commenced on 14 June 2024.

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.

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

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

Find out about how GMP clearances for manufacturing sites in Bulgaria can now be assessed via the Mutual Recognition Agreement (MRA) pathway.

We've granted a labelling exemption for the COVID-19 Vaccine, Pfizer (raxtozinameran), under the current Poisons Standard.

Find out about changes to choline salicylate access, starting from October 2023.

Find out how listed medicine ingredients, and requirements for their use, have been updated in the latest Therapeutic Goods (Permissible Ingredients) Determination.

Information about the TGA's safety monitoring of COVID-19 vaccines.

Information about the TGA's safety monitoring of COVID-19 vaccines.

Information about the TGA's safety monitoring of COVID-19 vaccines.

Delays in processing timeframes of applications to extend GMP Clearances.

The TGA has updated the Australian Regulatory Guidelines for Sunscreens (ARGS) to align with the data requirements for all ingredients proposed to be included in the Therapeutic Goods (Permissible Ingredients) Determination

Information about the TGA's safety monitoring of COVID-19 vaccines.

Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2023.