Articles

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.

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.

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.

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.

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

Delays in processing timeframes of applications to extend GMP Clearances.

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

Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2023.

This instrument is made under subsection 26BD(3) of the Therapeutic Goods Act 1989.

Listed medicine ingredients and requirements are updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 5) 2022.

Listed medicine ingredients and requirements are updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2022.

Listed medicine ingredients and requirements are updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2022.

A new Therapeutic Goods Determination for listed medicine ingredients commences on 1 March 2022.

A new Therapeutic Goods Determination for listed medicine ingredients commenced on 18 January 2022.

A new Therapeutic Goods Determination for listed medicine ingredients commenced on 25 October 2021.

The Therapeutic Goods (Permissible Ingredients) Determination has been updated.

The Therapeutic Goods (Permissible Ingredients) Determination has been updated.