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.

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 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.