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Australian Therapeutic Goods Advisory Council meeting statement, Meeting 6, 17 February 2015

3 November 2015

Record of issues

The Australian Therapeutic Goods Advisory Council (the Council) met for the sixth time at the Therapeutic Goods Administration Offices in Symonston on Tuesday 17 February 2015.

The TGA provided an update to the Council on various topics including the TGA Reforms: Progress report to 31 December 2014 and plans for 2015. This was the fifth progress report produced and will be published on the TGA website shortly.

The Council was also provided with an update on a number of consultation and review processes, including the TGA medicines labelling review, noting that in moving forward and developing the work plan for 2015, the final labelling order would take into account any implications of the Medicines and Medical Devices Regulation Review.

The Council was presented with the new Cabinet agreed Regulator Performance Framework. These new measures are required as part of the Government's consistent approach to Regulatory agencies which measure how regulators deliver rather than the outcomes they achieve. The first assessment period for the new framework is the 2015-16 financial year, with the first report to be delivered in August 2016. These new measures replace the current set of TGA key performance indicators.

The Council was also informed of the continuing collaboration with New Zealand's MedSafe since the decision not to proceed with the establishment of a joint therapeutic products regulator.

Members continued their discussion on TGA's international cooperation activities and noted the update provided on the TGA's international cooperation for both medicines and medical devices, including confidence building with European notified bodies.

The Council also received information on the Medical Channel. TGA educational information is being shown on the Medical Channel in approximately 250 GP waiting rooms, which are being viewed each month by more than 850,000 people. The new Medical Channel content is available on the TGA website under the educational materials webpage.

Next meeting

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

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

Email: atgac@tga.gov.au