Articles

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

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).

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.

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

Pharmacy software vendor links to TGA adverse event reporting web service

Medical Devices Safety Update, Volume 2, Number 3, May 2014

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