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

ByPharmOut Updated on

History of TGA & Medsafe ‘Early Warning System’ project discussions

One of the projects identified by the TGA and Medsafe when they formed ANZTPA in 2011, was to develop an early warning system to assist in the communication of potential safety issues with therapeutic products. This article provides a historical overview of the efforts of ANZTPA in 2011 and 2012.

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 aimed to allow a single point of entry for industry, with a common trans-Tasman regulatory framework.
  • Ultimately, as both business operations aimed to become further integrated, a single regulator would be established.

Early Warning System Project (TGA & Medsafe)

One of the projects identified by the TGA and Medsafe at that time was to develop an early warning system to assist in the communication of potential safety issues with therapeutic products.

That project commenced in April 2012, facilitated by a series of workshops looking at the system design and communication of safety information.

Those workshops examined the need for therapeutic product(s) regulations, the benefit-risk balance, product vigilance, the existing structures for spontaneous reporting, and how drug safety signals (from adverse event information) would be responded to/acted on.

Joint Workshops between TGA & Medsafe relating to their Early Warning System project

The aim of those early workshops was to identify basic principles and themes that would be important to an early warning system scheme and enable the early warning system to meet stakeholders’ needs. The purpose of the workshops was not to decide on a particular methodology for an early warning system.

Feedback from the early workshops included different suggested methodologies and outcome measures that were deemed 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.