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Statement of Intent

27 November 2012

On 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):

  1. 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.
  2. 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.
  3. 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.

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Content last updated: 27 November 2012

Content last reviewed: 27 November 2012

Web page last updated: 17 May 2013

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

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