Articles

Following our Essential Principles presentations on 11-12 September 2024, we have collated questions asked into themes to simplify finding information of relevance to you.

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.

This instrument is made under the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002.

Two new quality standards, one for MDMA and another for psilocybine, have been published.

This instrument is made under regulations 10AC, 10FA and 10HA of the Therapeutic Goods Regulations 1990.

This instrument is made under regulations 10AB, 10F and 10H of the Therapeutic Goods Regulations 1990.

Some changes are rolling out soon to improve your experience using guidance on our website. We’re aiming to make our content clearer, more accessible and easier to navigate.

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.

The Minister for Health and Aged Care, the Hon Mark Butler MP, introduced a bill that aims to reduce the widespread availability of vapes by controlling all levels of the supply chain.

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 Australian Border Force (ABF) and partners have seized more than five and a half million cigarette sticks and prevented hundreds of thousands of prohibited vapes and drug items from reaching the streets of Sydney.

This instrument is made under regulation 97 of the Therapeutic Goods Regulations 1990.

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

This instrument is made under Schedule 5A of the Therapeutic Goods Regulations 1990 and Schedule 4 of the Therapeutic Goods (Medical Devices) Regulations 2022.

This instrument is made under regulation 97 of the Therapeutic Goods Regulations 1990.

This instrument is made under subsection 19(7D) of the Therapeutic Goods Act 1989.

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

Arrangement under subsection 7C(1) of the Therapeutic Goods Act 1989

This instrument is made under subregulation 10JD(4) of the Therapeutic Goods Regulations 1990.

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.