Articles

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.

The TGA reminds businesses and media outlets that it is unlawful to publicly advertise prescription-only medicines, including prescription-only weight loss medicines.

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.

Amendments to the Therapeutic Goods Regulations 1990 (Schedule 5, item 6) have been made resulting in compounded GLP-1 RA products no longer being able to be compounded by pharmacists and supplied to patients.

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.

Some online health clinics are advertising and selling compounded medicines. However, it is important to know that compounded products are not identical to TGA approved products.

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.

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.

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

The TGA has published a final decision to reduce the maximum size of packs for various paracetamol products.

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

The TGA has issued an infringement notice for $13,320 to Sydney company JSHealth Vitamins Pty Ltd for an alleged breach 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) 2023.

The TGA is aware of several scams targeting consumers seeking semaglutide (Ozempic). Consumers are strongly advised not to use products unless they have come from a trusted source.

Supplies of Ozempic (semaglutide) have begun distribution in Australia but will remain quite limited for some time.

The TGA has today published an interim decision to reduce the maximum pack sizes for various paracetamol products.

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.

New guidelines and mandatory requirements for listed medicines ingredients have come into effect on 1 February 2023.

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.