Articles

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.

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.

We have issued an infringement notice to the New South Wales based company for the alleged supply of a complementary medicine that was missing a mandatory warning statement.

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.

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

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.

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 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.

We issued an infringement notice for $13,320 to the New South Wales based company Marvel Health (Australia) Pty Ltd. This was for an alleged failure to comply with a notice to provide information about a complementary (listed) medicine.

We have issued a notice to Pracmed Healthcare Pty Ltd to cease advertising indications related to weight loss surgery and cognitive function.

We've created a new GMP clearance Sponsor Information Dashboard (SID) to provide industry with current information about our processing times, workload and key messages. We have also updated our GMP clearance guidance.

Information about GMP clearances issued via the MRA Pathway that expire on 31 December 2023 as well as information on the ongoing use of the GMP clearance questionnaire.

‘Haytox’ has not been approved by the TGA or included in the Australian Register of Therapeutic Goods (ARTG).

From 30 November 2023, some sports supplements will be regulated as therapeutic goods and must be included in the Australian Register of Therapeutic Goods (ARTG).

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

Want to know what’s in your medicines? The obvious place to start is with the medicine’s label, but there may be more to it.

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

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

More applications for Good Manufacturing Practice (GMP) clearances can now be assessed under the TGA’s MRA pathway.

The TGA has issued an infringement notice totalling $13,320 to Sydney company JSHealth Vitamins Pty Ltd for supplying a complementary medicine that allegedly did not conform with legal requirements.

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

Before you take a weight loss supplement or medicine, there are things to consider.