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The ANZTPA Project

About the trans Tasman therapeutic products agency project

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On 10 December 2003, the Australian and New Zealand Governments signed an agreement to establish a joint regulatory scheme for therapeutic products.

The joint scheme will regulate medicines (including complementary medicines) and medical devices and is expected to come into force on the passage of legislation and ratification of the treaty.

What is the project about?

The trans Tasman therapeutic products agency project has involved New Zealand and Australia giving consideration to establishing a joint agency to regulate therapeutic products (medicines, medical devices and complementary medicines/dietary supplements that have therapeutic uses) in both countries.

The decisions of the Australian and New Zealand Governments to establish a trans Tasman agency to regulate therapeutic products have moved the project into a new phase. This phase of the project sees the development of the final details of the regulatory framework and the legislation underpinning the joint agency, the treaty between Australia and New Zealand, and the transitional arrangements to create a new agency.

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Why are we establishing a trans Tasman therapeutic products agency?

The key objectives in establishing the Agency are to:

The establishment of a trans Tasman agency is also likely to lead to closer cooperation between countries and regulators in the Asia-Pacific region.

Trans Tasman Mutual Recognition Arrangement

The TTMRA is an arrangement between the Australian Commonwealth, State and Territory governments and the government of New Zealand. The TTMRA seeks to remove regulatory barriers and facilitate trade between Australia and New Zealand.

The differences between the New Zealand and Australian systems for regulating therapeutic products were sufficient to necessitate a special exemption to the TTMRA that allowed officials time to assess options to resolve the need for a special exemption.

The options identified for resolving the special exemption were mutual recognition, permanent exemption and harmonisation of regulatory systems.

Australian and New Zealand Health Ministers agreed that harmonisation of regulatory systems was likely to be the best option. The establishment of a trans Tasman therapeutic products agency will deliver a harmonised approach with the flow on benefits of lowering trade barriers between Australia and New Zealand and enhancing CER.

Regulatory capacity

Regulatory Impact Assessments undertaken by the New Zealand Institute of Economic Research (NZIER) in 2000 and 2002 confirmed that New Zealand's current system for regulating therapeutic products is not sustainable. New Zealand does not have sufficient capacity in terms of technical expertise to continue to evaluate the risks and benefits of increasingly complex high risk products (such as medicines of biological origin). Such expertise is in demand internationally and is scarce in some disciplines. Australia may face a similar challenge to its regulatory capacity in the longer term.

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What will form the basis of the new agency?

The new Agency will replace the Australian Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe), and be accountable to the Australian and New Zealand Governments. It will be recognised in law in both Australia and New Zealand and assume responsibility for the regulatory functions currently undertaken in both countries.

What will the agency do?

The role of the Agency will be to safeguard public health and safety through regulation of the quality, safety and efficacy or performance of therapeutic products in both Australia and New Zealand.

The regulatory activities of the agency will include:

A risk-based approach will be taken so that the level of regulation is commensurate with the level of risk associated with the products.

What are the advantages of having a trans Tasman therapeutic products agency?

The Agency has a number of benefits for both countries. The Agency will:

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How will the agency be set up?

The Agency will:

The Agency will be overseen by a two-member Ministerial Council comprising the New Zealand Minister of Health and the Australian Health Minister. The Agency will also have a five member Board. A Treaty will establish the Ministerial Council and the Board of the agency. The Board will be responsible for the strategic direction and financial management of the Agency. One of the Board members, the Managing Director, will be responsible for regulatory decisions about therapeutic products and for the day to day management of the Agency. The Board and the Managing Director will be appointed by the Ministerial Council.

The framework for the regulatory scheme administered by the Agency will be set up under the Treaty and implemented through Acts of Parliament in both countries, a single set of Rules made by the Ministerial Council, and technical Orders made by the Managing Director.

Accountability arrangements

It has been agreed that a fundamental requirement for the joint agency must be that the Agency has no lesser accountability to Ministers, Parliaments, industry and the public than is currently the case for Medsafe and the TGA. Work continues on further defining accountability requirements for the Agency, such as:

Stakeholder consultation

Since 1998 there has been extensive consultation with industry, health professionals and consumer groups on the proposal to establish a joint therapeutic products agency. Consultation will continue with key stakeholders, especially on the final proposals for the establishment and implementation of a joint regulatory scheme.

Discussion documents and other reports and documents designed to keep stakeholders informed on developments towards the establishment of a joint agency can be found on this website. Stakeholders should regularly check the website for new information and updates on progress towards establishing the trans Tasman agency.

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Content last updated: 27 November 2012

Content last reviewed: 27 November 2012

Web page last updated: 17 May 2012

URL: http://www.anztpa.org/about/anztpa_project.htm

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