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Landmark agreement to achieve world standards in therapeutic products



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PRIME MINISTER

LANDMARK AGREEMENT TO ACHIEVE WORLD STANDARDS IN THERAPEUTIC PRODUCTS

The Australian and New Zealand Governments will establish a world leading agency to regulate medicines, medical devices and other therapeutic goods in both countries.

Prime Minister Julia Gillard and New Zealand Prime Minister John Key today signed a statement of intent to implement the joint agency progressively over a period of up to five years.

The new agency will reduce regulatory costs for industry and improve the standard of therapeutic goods produced in our two countries.

Put simply, it will ensure that Australians and New Zealanders have access to medicines, medical devices and other therapeutic goods that are of world-leading standard.

The new scheme will also encourage economic integration of our pharmaceutical markets and enhance the reputation of Australian and New Zealand products on the world market.

The Prime Minister said the new agency - the Australian and New Zealand Therapeutic Products Agency (ANZTPA) -- will replace our Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe). It will be accountable to both the Australian and New Zealand Governments.

The staged implementation will begin straight away so consumers and industry can start benefiting from the new arrangements.

The TGA and Medsafe will take immediate steps to share information, training and expertise between our two countries to bring immediate benefits to both agencies.

As business operations become increasingly integrated and a following a review of progress, the single regulator will then be established.

Agreement for a joint regulatory scheme was first reached in 2003, however, negotiations between the countries were suspended in July 2007.

The new arrangements will build on reforms previously developed through to 2007, many of which are already underway within Australia’s TGA.

CANBERRA 20 JUNE 2011

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