Early warning of safety issues with therapeutic products

Following the signing of a Statement of Intent by the Australian and New Zealand Prime Ministers in June 2011, to establish the Australia New Zealand Therapeutic Products Agency (ANZTPA), the Australian Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) were asked to identify a series of projects which would deliver early benefits to consumers, health practitioners and the pharmaceutical industry. All parties agreed that, along with several other projects, there were significant benefits to be achieved by developing an early warning system to communicate potential safety issues with therapeutic products. Currently, TGA and Medsafe are developing an early warning system to communicate potential safety issues with therapeutic products. The project is one of five ‘Business-to-Business’ projects being undertaken by Medsafe and TGA, as both agencies move to become a joint regulatory agency with the establishment of the ANZTPA over the next four years. In April 2012, the TGA and Medsafe jointly hosted a number of workshops with key stakeholders to obtain information about the design of this system and how safety information should be communicated. The purpose of the workshops was not to decide on a particular methodology for an early warning system. Workshop participants were provided with a briefing document detailing the aims, possible scenarios and a list of questions designed to stimulate discussion: Early warning of safety issues with therapeutic products: workshop briefing document. The feedback from the workshops will inform the design of the system: Early warning of safety issues with therapeutic products: summary of feedback. Medsafe and the TGA are now in the process of designing an early warning system.

TGA, 30 August 2012 ;http://www.tga.gov.au/ ;