Articles

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). 

Pharmacy software vendor links to TGA adverse event reporting web service

Senator Fiona Nash, Assistant Minister for Health, has launched the Medicine Shortages Information Initiative.

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

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 and Medsafe have developed a common list of colouring substances allowed in medicines for oral and topical use.

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.