Articles

The Australian and New Zealand Governments have agreed to cease efforts to establish a joint therapeutic products regulator, the Australia New Zealand Therapeutic Products Agency (ANZTPA).

The annual report contains information about hip, knee and shoulder orthopaedic implants that are having higher-than-expected rates of revision.

News about information to assist importers, manufacturers and suppliers to determine whether their products are food or therapeutic goods

Garcinia gummi-gutta, also commonly known as Garcinia cambogia, can be used as an ingredient in lower-risk (listed) medicines.

The TGA begins piloting electronic submissions for registered medicines using the eCTD format, supported by updated software and a revised Module 1 aligned with European standards.

Pharmacy software vendor links to TGA adverse event reporting web service

Approval of the Therapeutic Goods

Approval of the manner of making requests under subsection 9D(3) of the Therapeutic Goods Act 1989 to vary the entry in the Australian Register of Therapeutic Goods of registered therapeutic goods

Consultation on low value turnover exemption (LVT) scheme

The amendments made to the Therapeutic Goods Act 1989 (the Act) by the Therapeutic Goods Amendment (2013 Measures No. 1) Act 2014 commenced on 28 February 2014.

The TGA reviewed studies on tartrazine, a yellow colouring used in medicines, and found it safe when properly labelled, with no strong evidence of harm like allergies or behavioural issues.

Pilot web service for transmission of adverse event reports from medical software to the Therapeutic Goods Administration

Mifepristone and misoprostol can be prescribed in Australia by registered medical practitioners.

The Australian government will introduce a comprehensive package of reforms for Australia's Therapeutic Goods Administration (TGA) to ensure the regulation of medicines and medical devices is more effective and transparent.