Australian Therapeutic Goods Advisory Council meeting statement, Meeting 5, 5 August 2014

Record of issues

The Australian Therapeutic Goods Advisory Council (the Council) met for the fifth time at the Therapeutic Goods Administration Offices in Symonston on Tuesday 5 August 2014.

The Council reviewed progress made against the Blueprint Implementation Plan. Nine recommendations were implemented in 2013-14. Members noted that there has been some minor revisions to the implementation schedule namely (1) amendments associated with the permitted indications for listed medicines; (2) review and updating of the Uniform Recall Procedure for Therapeutic Goods; and (3) a modified medical device reform package. A report on progress, TGA Reforms: A blueprint for TGA's future: Progress Report as at 30 June 2014, has been published on the TGA website.

Members were provided with a report against TGA's key performance indicators. The Council welcomed the report, noting that it provides a good assessment of progress against the TGA's broad strategic intent.

An update on the Medicines Shortages Information Initiative was provided. The Initiative; which was launched by the Assistant Minister for Health on 26 May; provides health professionals and consumers with information about temporary or permanent disruptions to the supply of prescription medicines in Australia. A formal evaluation of the Initiative will be conducted in 12 months.

The meeting noted that much of the groundwork to implement TGA's External Communication and Education Framework has been consolidated over the past six months. TGA's Public Contact Team (PCT) continues to receive a large number of enquiries from stakeholders. The data collected by the PCT is being used to inform the development of communication and education activities. Over the next six months the TGA will participate in a variety of conferences and events. A list of events in which the TGA is participating is published on the TGA website.

Members continued their discussion on TGA's international cooperation activities. TGA continues to strengthen collaboration with overseas regulators with a view to increasing regulatory convergence and worksharing. Members noted that TGA is actively participating in an International Coalition on Medicines Regulatory Authorities, recently established to provide strategic direction at the agency head level.

Next meeting

The next meeting of the Council is planned for February 2015.

For further information on the Council, please contact the Secretary:

Email: atgac@tga.gov.au