Articles

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 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

Approval of the 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

Medical Devices Safety Update, Volume 2, Number 1, January 2014

The TGA is advising consumers against purchasing or using black salve, red salve or cansema products.

Medicines Safety Update, Volume 4, Number 4, August 2013

THERAPEUTIC GOODS ACT 1989

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

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

Hospital supply departments, health professionals, carers and users should check that male urinal bottles are free of sharp edges, both inside and outside the bottle. Any cracks, chips or sharp edges may injure users.

The TGA Prescription Medicines Streamlined Submissions Process Newsletter [formerly the Prescription medicine BPR update (BPR update)] reports on progress of the streamlined submission process.

We have received reports of haemodialysis catheters becoming dislodged at the Luer lock connection point. In some cases, the dislodgement was not detected, as the catheter and all connections were out of sight.