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ANZTPA Implementation Ministerial Council communique

Trans Tasman Ministerial Council agrees foundations for joint therapeutic products regulator

28 January 2012

A joint Australia New Zealand Therapeutic products regulation scheme moved one step closer today when Ministers from both countries met in Melbourne for the first meeting of the Australia New Zealand Therapeutic Products Agency Implementation Ministerial Council.

The meeting, chaired by Australian Health Minister, the Hon Tanya Plibersek MP and comprising the Hon Tony Ryall MP, New Zealand Minister for Health, the Hon Craig Foss MP New Zealand Minister for Commerce and the Hon David Bradbury MP, Australian Parliamentary Secretary to the Treasurer, discussed and agreed on key elements to establish a joint Trans-Tasman therapeutic products regulator.

Over a period of five years the new regulatory Agency will replace Australia's Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) with the objective of ensuring that consumers have access to safe, quality medicines and medical devices which are brought to market through a single approval process for both countries.

Resources will be shared to ensure rigorous evaluation and that there is surveillance of products once they are available on the market. Streamlining Trans-Tasman regulation will also further economic integration and benefit industry in both countries.

At the meeting today Ministers noted the Statement of Intent signed by the Australian and New Zealand Prime Ministers in June 2011; approved the Terms of Reference for the Ministerial Council; approved the governance framework for the implementation of the joint scheme and the high level project plan for the establishment of ANZTPA. It also noted progress on projects currently being undertaken jointly through Australia's TGA and Medsafe in New Zealand.

In particular, Ministers agreed that an information website containing advice on adverse reactions to medicines will be available to the public in both Australia and New Zealand by 30 June 2012. This provides enhanced access to safety information and improves transparency. Ministers noted that work will continue on developing a common streamlined, but rigorous process to evaluate and assess the safety, quality and efficacy of over the counter medicines before they are brought to the market.

Ministers today also agreed on a number of initial joint TGA/Medsafe projects that will maintain momentum for the establishment of the joint agency and provide early gains for consumers and industry through enhanced safety and quality processes. There are five joint projects currently being undertaken:

• By 30 June 2012, the public in Australia and New Zealand will be able to search a data base with information on adverse reactions to medicines. This will be prospectively populated with data from both countries.
• Over the next 12 months TGA and Medsafe will deliver a common recalls portal for therapeutic products.
• A common early warning system will also be delivered over the next 12 months to inform the public of potential safety issues concerning therapeutic products.
• Over the next 12 months TGA and Medsafe will work together to review and reform the business process for the evaluation of over the counter medicines. A common approach to lodgement of applications, assessment, evaluation and registration in TGA and Medsafe will be the end result.
• In early 2013 TGA and Medsafe will have established an integrated capability to conduct audits to assess good manufacturing practice (GP). To this end, in early 2012, both organisations will commence sharing of GMP reports.

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