Articles

Mundipharma Pty Ltd has paid penalties of $302,400 in response to 24 infringement notices issued by the TGA

Results of product testing

A new S41BD(3) instrument has been signed to declare that some nappy rash products are not to be medical devices for the purposes of the Act

The Permissible Ingredients Determination has been updated.

New requirements for listed medicines containing Andrographis paniculata

We will closely consider the judgment including any further improvements that could enhance the regulatory system in Australia.  

The Permissible Ingredients Determination has been updated.

Acalabrutinib receives approval through the second international collaborative review initiative between the TGA, FDA and Health Canada

The TGA has joined the ICMRA and the WHO in a coordinated global approach to fighting antimicrobial resistance

Consumer Healthcare Products Australia to handle all medicine advertising pre-approval applications

The Complementary Healthcare Council of Australia is no longer accepting advertising pre-approval applications

The Therapeutic Goods (Permissible Indications) Determination has been updated

The Therapeutic Goods Administration is aware that a member of the public has purported to be a Commonwealth public official during a recent incident in Melbourne

A warning to consumers about undergoing procedures using unapproved medical devices

Changes are coming in November to the advertising pre-approval arrangements for some complementary medicines advertisements

Therapeutic Goods (Declared Goods) Order 2019 consolidates and replaces several instruments

Japan has recently been added to the list of Foreign Countries and Jurisdictions determined to be comparable overseas regulators

The TGA has released the findings of its review into breast implants and breast tissue expanders

International Collaborative Review Initiative gives provisional approval of lenvatinib in combination with pembrolizumab

Infringement notice issued for the alleged advertising of Schedule 4 substances

Infringement notice issued for the alleged advertising of a cancelled therapeutic good

New requirements for caffeine and caffeine-containing ingredients within listed medicines

An amendment to the Therapeutic Goods (Permissible Ingredients) Determination commenced on 2 September 2019.

Update on amendments to the Therapeutic Goods Advertising Code (No.2) 2018 and medicines advertising pre-approval

The TGA has commenced work on a sector-wide compliance activity relating to the advertising of bioresonance devices