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Progress on trans-Tasman therapeutics agency

Health News from Australia
Health News from New Zealand

The Australian and New Zealand governments further progressed their commitment to the establishment of the Australia New Zealand Therapeutic Products Authority (ANZTPA) at an Interim Ministerial Council meeting in Wellington recently.

At the meeting the New Zealand Minister for State Services, Annette King, and the Australian Parliamentary Secretary for Health, Christopher Pyne, covered a range of issues including the importance of consultation with stakeholders.

The aim of the proposed joint regulatory scheme for therapeutic products is to protect the health and safety of Australians and New Zealanders. It will do this by regulating the safety, quality and effectiveness of prescription and over-the-counter medicines, complementary medicines, medical devices, tissue and cellular therapies, and blood and blood products in both countries.

" Consultation is crucial in ensuring the new regulatory scheme meets the overall objective of safeguarding public health and safety," Ms King said.
" It is an opportunity for industry, other stakeholders and consumers to provide input into how the scheme will operate."

Mr Pyne said that in June this year the first round of public consultation meetings were held in New Zealand and Australia.

" They were attended by more than 1000 people as part of the ongoing consultation process with stakeholders," Mr Pyne said.

" We are also pleased that many stakeholders took the opportunity to make submissions during this first phase of public consultation, which included consideration of the draft rules for medicines and medical devices."

At the ministerial meeting, Ms King and Mr Pyne also considered the plans for the second phase of consultation on the proposed joint regulatory scheme, expected to begin in mid-September 2006. This phase will include the release of the draft advertising rule, draft rule for blood and blood components, and the further aspects of the draft administration rule, such as scheduling.

Ms King and Mr Pyne also agreed in principle to the use of third parties for conformity assessment for Australian and New Zealand manufacturers of medical devices, with the ANZTPA making the licensing decision.

The ministerial meeting ratified the appointment of the chair, deputy chair and membership of a new Advertising Implementation Steering Group. The steering group will provide guidance on proposals for the joint regulation of the advertising of therapeutic products under the proposed Authority.

" Sue Knowles, formerly an Australian senator, has been appointed as the chair of the steering group," Mr Pyne said.

" As a key member of Australia's Senate Community Affairs Legislation Committee, Ms Knowles gained an extensive understanding of health, aged care, Indigenous health, welfare and related matters."

" Tony Miller, the chief executive of New Zealand's Self Medication Industry Association, will also bring extensive experience to the role of deputy chair," Ms King said.

The Interim Ministerial Council also received an update on the regulatory framework for human cellular and tissue therapies, which would be regulated under the proposed ANZTPA. It was noted that consultation with stakeholder groups is currently under way to further develop the detail of the proposed regulatory scheme for human cellular and tissue therapies.

More information about the proposed trans-Tasman joint regulatory scheme, along with details about the current consultation phase and how to make a submission, can be found on the Australia New Zealand Therapeutic Products Authority website: www.anztpa.org.



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