Articles

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

In this issue: Action after registry data analysis; Environmental extremes; Button battery dangers; Infant sleep positioners reviewed

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

We have launched the upgraded TGA Business Services site - an improved way to help industry do business with the TGA.

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.

An overview of the process for determining the most effective composition for the annual influenza virus

The TGA is participating in an international collaboration programme led by the European Union (EU).

Safety though adverse event reporting; Recommendations for avoiding or dealing with surgical implant tool breakages; IRIS inSite pilot off to promising start; Clinical alarm issues still pose top hazard; Recent safety alerts

Undertaking to the Secretary of the Australian Government Department of Health given for the purposes of section 42YL of the Act

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).

New regulations will be introduced to allow Australian manufacturers to obtain market approval for most medical devices using conformity assessment certification from European notified bodies.

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

The TGA is participating in a pilot of the Decentralised Procedure (DCP) of the European Union, a collaboration on the evaluation of generic drug applications.

The TGA has agreed, in principle, to participate in a pilot of the Decentralised Procedure (DCP) of the European Union, a collaboration on the evaluation of generic drug applications.

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.

The Therapeutic Goods Administration (TGA) is set to strengthen its collaboration with the European Directorate for the Quality of Medicines and HealthCare (EDQM).