The TGA and Medsafe developing an early warning system for potential safety issues with therapeutic products

The TGA and Medsafe developing an early warning system for potential safety issues with therapeutic products

As a result of the Statement of intent by Australia and New Zealand in June 2011, the Australia New Zealand Therapeutic Products Agency (ANZTPA) was formed as a joint scheme for the regulation of therapeutic goods.
The aim of ANZTPA is to allow the TGA and Medsafe to begin a program of work-sharing, including sharing of data and information, training and building centres of excellence in each country. The partnership will allow a single point of entry for industry with a common trans-Tasman regulatory framework. Ultimately, as both business operations become further integrated, a single regulator will be established.
One of the projects identified by the TGA and Medsafe is to develop an early warning system to assist in the communication of potential safety issues with therapeutic products. This project commenced in April 2012 with a series of workshops looking at the system design and communication of safety information.
The workshops looked at the need for therapeutic products regulation, the benefit risk balance, product vigilance, the structure for spontaneous reporting and how safety signals from adverse event information will be acted on.
The aim of the workshops was to identify basic principles and themes that would be important to such a scheme, and enable the scheme to meet stakeholders’ needs. The purpose of the workshops was not to decide on a particular methodology for an early warning system.
The feedback from the workshops included different suggested methodologies and outcome measures that would be useful to measure the success of an early warning system. These included market research, surveys, studies, measure awareness and review of accuracy of the scheme.

By Eoin Hanley
Senior Consultant-PharmOut

Read more on similar topics here and here.

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