Early warning of safety concerns with therapeutic products
The Australian Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) have developed an early warning system to communicate potential safety concerns with therapeutic products. This scheme will operate in parallel in Australia and New Zealand.
The TGA and Medsafe will apply the agreed communication process independently to potential safety concerns identified with therapeutic products through their existing therapeutic product vigilance processes. These communications will be country specific and may differ reflecting different legislative requirements, and different availability and/or usage of certain therapeutic products between Australia and New Zealand.
- In Australia, the Early Warning System communications are available on the TGA website.
- In New Zealand, the Early Warning System communications are available on the Medsafe website.
Following the signing of a Statement of Intent by the Australian and New Zealand Prime Ministers in June 2011, to establish the ANZTPA, Medsafe and TGA 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.
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.
- Early warning of safety issues with therapeutic products: workshop briefing document
- Early warning of safety issues with therapeutic products: summary of feedback
In March 2013, the TGA and Medsafe sought comments and input from interested parties on the proposed process and example web pages for an early warning system for medicines and medical devices. The feedback from this consultation has helped inform the Australian and New Zealand governments on implementation of this system.
- In Australia, further details on this consultation including a list of submissions received can be found on the TGA website.
- In New Zealand, further details on this consultation including a list of submissions received can be found on the Medsafe website.
Content last updated: 4 June 2013
Content last reviewed: 4 June 2013
Web page last updated: 4 June 2013