Transition to the Australia New Zealand Therapeutic Products Agency (ANZTPA)

The Treaty

The Government of Australia and the Government of New Zealand (referred to in this Agreement as “the Parties”):

CONSCIOUS of their geographic proximity, long-standing friendship, and close historic, political, and economic relationship;

RECOGNISING the development of that relationship through the Australia New Zealand Closer Economic Relations Trade Agreement done at Canberra on 28 March 1983, and subsequent arrangements and agreements developed within that framework;

NOTING in particular the Arrangement relating to Trans-Tasman Mutual Recognition signed by the Australian Prime Minister, Premiers and Chief Ministers on 14 June 1996 and by the New Zealand Prime Minister on 9 July 1996, and the cooperation programme in relation to regulatory requirements for therapeutic products pursued under the auspices of that Arrangement;

AWARE that this relationship will be significantly strengthened and that both countries will benefit through the development of a joint Trans-Tasman scheme for the regulation of therapeutic products;

ACKNOWLEDGING their commitment to securing trade liberalisation and an outward-looking approach to trade;

CONSCIOUS of their obligations under the Agreement establishing the World Trade Organization done at Marrakesh on 15 April 1994;

AFFIRMING their shared commitment to safeguarding public health and safety through a regulatory regime consistent with international best practice for the regulation of the quality, safety, and efficacy or performance of therapeutic products; and

DESIRING therefore to establish a joint scheme for the regulation of therapeutic products in both Australia and New Zealand, to be administered by a single world-class agency responsible to both Parties;

HAVE agreed as follows:

Statement of Intent

Australia New Zealand Therapeutic Products Agency 77On 20 June 2011, the Prime Ministers of Australia and New Zealand reaffirmed their commitment to the establishment of the Australia New Zealand Therapeutic Products Agency (ANZTPA) to administer a joint regulatory scheme for therapeutic products. This reaffirmation acknowledged that the New Zealand Government will introduce a separate scheme to regulate certain natural health products in the New Zealand market.

Prime Ministers have agreed that a three stage approach over a period of up to 5 years will be adopted to progressively achieve this goal by mid-2016. The threestages involve the two countries’ regulators, Australia’s Therapeutic Goods Administration (TGA) and New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe):

Commencing a program of Business to Business (B2B) projects and work-sharing. This will enable the separate regulatory systems of each country to be supported with single sets of data, expertise and internal administrative advisory processes. Improved regulatory practices will lead to immediate benefits including improved public health outcomes and better value for money for industry and governments with greater efficiency in regulatory processes.

Establishing a Single Entry Point for industry and agreeing a common trans-Tasman regulatory framework. While each country will retain its own regulator and continue to make its own regulatory decisions in this stage, business will benefit from a significant reduction in red tape with only one set of requirements to operate in two countries. The creation of the new world class regulatory framework will further increase the public health benefit for consumers, reduce the regulatory burden for industry and enhance the reputation of New Zealand and Australian therapeutic products on the world market.

Increasingly Integrate Business Operations, including single operational and decision making mechanisms. Following passage of implementing legislation, ratification of the Treaty and final confirmation of arrangements, the separate national regulators will be absorbed into the ANZTPA. At this time New Zealand will be able to decide whether to maintain its separate scheme to regulate certain health products, or bring those products under ANZTPA.

This statement of intent reflects a significant step in the lengthy process since the Treaty between Australia and New Zealand was signed in 2003 envisaging all therapeutic products being regulated under a joint regulatory scheme by a single regulatory agency.

The agreement to establish a single Australia New Zealand Therapeutic Products Agency is also another important step forward in the development of closer economic relations between Australia and New Zealand. In addition, deliverables from this project such as regulatory harmonisation will strengthen the broader relationship between the two countries and benefit industry in both countries.

Arrangements of Governance

Australia New Zealand Therapeutic Products Agency 77The project to establish ANZTPA is a complex multi-year project requiring effective governance arrangements. When committing to the project in June 2011, the Australian and New Zealand Prime Ministers agreed to establish two key joint governance bodies:

a Ministerial Council, including Australian and New Zealand Health Ministers and other relevant ministers, to oversight implementation; and
a Transition Agency, resourced by both Australia and New Zealand, to advise the Ministerial Council and drive implementation of the scheme.
A number of other entities have been set up to support the roles of the Ministerial Council and Transition Agency. These are:

The Secretaries’ Group (comprising the CEOs of the New Zealand Ministry of Health and the Australian Department of Health) which is a joint entity driving outcomes to give effect to the Treaty and the Statement of Intent, as well as providing support, advice and recommendations to the Ministerial Council.

A Trans-Tasman Senior Officials’ Group (TTSOG), which is a formal body with membership drawn from the relevant policy agencies in both countries. Membership of this group includes officials from the Australian Department of Health, the New Zealand Ministry of Health, the New Zealand Ministry of Economic Development, the Australian and New Zealand Departments of Prime Minister and Cabinet, the Australian and New Zealand Treasuries, the Australian Department of Finance and Deregulation, the Australian Department of Foreign Affairs and Trade, the New Zealand Ministry of Foreign Affairs and Trade, the Australian Attorney-General’s Department and the New Zealand Ministry of Justice. The Head of the Transition Agency and Heads from both Regulators are also members of the TTSOG. Other relevant officers are co-opted where consideration of issues falls within their area of responsibility.

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.

On this page

  • What is the project about?
  • Why are we establishing a trans Tasman therapeutic products agency?
  • What will form the basis of the new agency?
  • What will the agency do?
  • What are the advantages of having a trans Tasman therapeutic products agency?
  • How will the agency be set up?
  • Stakeholder consultation

What is the project about?

Australia New Zealand Therapeutic Products Agency 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.

Text of the treaty: Agreement between the Government of Australia and the Government of New Zealand for the establishment of a joint scheme for the regulation of therapeutic products
Other documents relating to the treaty

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Why are we establishing a trans Tasman therapeutic products agency?
The key objectives in establishing the Agency are to:

Establish a trans Tasman regulatory scheme for therapeutic products that will safeguard public health and safety in Australia and New Zealand by regulating therapeutic products and maintain an effective and sustainable regulatory capacity in both countries; and Resolve the special exemption for therapeutic products under the Trans Tasman Mutual Recognition Arrangement (TTMRA) in a manner that facilitates trans Tasman trade and enhances Closer Economic Relations between Australia and New Zealand.

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

Australia New Zealand Therapeutic Products Agency 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.

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:
pre-market evaluation and assessment; product licensing; controls on manufacture; post-market monitoring and surveillance; and setting standards.

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: assist in creation of a single market for therapeutic products; facilitate trade and reduce compliance costs by replacing dual regulatory processes with harmonised regulatory requirements; strengthen each country’s regulatory capacity to meet a new wave of innovative therapeutic products which are being driven by emerging technologies and globalisation; and ensure consumers have early access to new products entering the market, while maintaining confidence in public health and safety.

How will the agency be set up?

The Agency will: have a distinct legal identity and be recognized in the legislation of both countries; be established, and operate, in accordance with key principles set out in Treaty between the two countries; be directly accountable to both Ministers and to both Parliaments; deliver common regulatory outcomes and have the authority to implement and enforce laws in both countries; operate subject to the ability of either country to depart from the joint regulatory scheme. This will apply in extraordinary circumstances, under agreed criteria and within agreed time frames and will include a process for the future resolution of issues that have led to a separate decision; and be subject to common regulatory review and appeal mechanisms that are suitable for therapeutic products and provide access for industry in both countries.

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: procedures for appropriate stakeholder input into, and parliamentary scrutiny of, initial and subsequent legislation, including Rules and Orders; review of regulatory decisions; annual, corporate and financial planning; access to official information; privacy requirements; and human rights/anti-discrimination regimes.

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.