Articles

The TGA has issued a discussion paper on the use and misuse of prescription strong opioids, such as oxycodone, and whether there is a need for specific regulatory responses

Information about the TGA operations over the 2015/16 Christmas/New Year period

Stage two report for the Review of Medicines and Medical Devices has been released

The Therapeutic Goods Administration has published an interim decision on a proposal to up-schedule codeine

The TGA has imposed two new conditions on the inclusion of the SynchroMed II Programmable Pump in the Australian Register of Therapeutic Goods

From 1 July 2015 commercial IVD medical devices will be monitored under the Regulatory Compliance Framework

From 1 July 2015, new guidance and forms for Additional trade names and Extensions of Indications applications will be available

Between 24 May and 16 June, the ACBPS, TGA and APVMA took part in an international crackdown on fake and illegal medicines

The TGA is aware of regulatory action undertaken by the US Food and Drug Administration (FDA) in relation to the Maquet manufacturing facility in Hudson, New Hampshire, USA

Next Tuesday we will be launching the new TGA Business Services site.

The TGA and NPS Medicinewise have worked together to create two interactive online learning modules

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

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