Australian Parliamentary Secretary for Health On Treaty

WELLINGTON, Dec. 10 /MediaNet International-AsiaNet/ --

The Australian Parliamentary Secretary for Health, Trish Worth, said she was delighted at the historic signing today in Wellington of a Treaty between Australia and New Zealand that will result in Australia's Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) replaced by a single agency accountable to both the New Zealand and Australian governments.

"The new agency will regulate therapeutic products in both countries, including medical devices and prescription, over-the-counter and complementary medicines," Ms Worth said.

The agency is expected to commence operation in 2005.

Ms Worth, signed the Treaty with the New Zealand Minister for Health, Annette King, which represented an historic step in regulatory arrangements between Australia and New Zealand.

"The joint regulatory scheme and its administration by a single joint agency represents a significant advance in trans-Tasman regulatory co-operation and will effectively integrate the therapeutic products regulatory systems of both countries, comprising an unprecedented level of international co-operation," Ms Worth said.

"The Treaty sets out the governance and accountability arrangements for the new agency and how it is to be established. It also provides a framework for the joint regulatory scheme for therapeutic products.

"The Treaty is the result of years of collaboration between TGA and Medsafe and extensive consultation with stakeholders in both countries regarding the new regulatory scheme.

"This consultative approach will continue with further consultation to occur with stakeholders during the development of the legislation that will give effect to the regulatory scheme, to be developed before the joint agency commences operation," Ms Worth said.

The Australian government has also released the report of the Review of Administrative Arrangements for Commonwealth Public Health and Safety that recommended the establishment of the joint therapeutics scheme with New Zealand.

"Consistent with a recommendation in the Review, the administrative arrangements for the joint agency will include the Office of the Gene Technology Regulator and the Office of Chemical Safety which includes the National Industrial Chemicals Notification and Assessment Scheme (NICNAS), although these regulators will only operate in Australia," Ms Worth said.

SOURCE: Australian Government Department of Health & Ageing

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