Publications

Australia New Zealand Therapeutic Products Agency (ANZTPA)

Trans Tasman Ministerial Council agrees foundations for joint therapeutic products regulator

28 January 2012

A joint Australia New Zealand Therapeutic products regulation scheme moved one step closer today when Ministers from both countries met in Melbourne for the first meeting of the Australia New Zealand Therapeutic Products Agency Implementation Ministerial Council.

The meeting, chaired by Australian Health Minister, the Hon Tanya Plibersek MP and comprising the Hon Tony Ryall MP, New Zealand Minister for Health, the Hon Craig Foss MP New Zealand Minister for Commerce and the Hon David Bradbury MP, Australian Parliamentary Secretary to the Treasurer, discussed and agreed on key elements to establish a joint Trans-Tasman therapeutic products regulator.

Over a period of five years the new regulatory Agency will replace Australia's Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) with the objective of ensuring that consumers have access to safe, quality medicines and medical devices which are brought to market through a single approval process for both countries.

Resources will be shared to ensure rigorous evaluation and that there is surveillance of products once they are available on the market. Streamlining Trans-Tasman regulation will also further economic integration and benefit industry in both countries.

At the meeting today Ministers noted the Statement of Intent signed by the Australian and New Zealand Prime Ministers in June 2011; approved the Terms of Reference for the Ministerial Council; approved the governance framework for the implementation of the joint scheme and the high level project plan for the establishment of ANZTPA. It also noted progress on projects currently being undertaken jointly through Australia's TGA and Medsafe in New Zealand.

In particular, Ministers agreed that an information website containing advice on adverse reactions to medicines will be available to the public in both Australia and New Zealand by 30 June 2012. This provides enhanced access to safety information and improves transparency. Ministers noted that work will continue on developing a common streamlined, but rigorous process to evaluate and assess the safety, quality and efficacy of over the counter medicines before they are brought to the market.

Ministers today also agreed on a number of initial joint TGA/Medsafe projects that will maintain momentum for the establishment of the joint agency and provide early gains for consumers and industry through enhanced safety and quality processes. There are five joint projects currently being undertaken:

By 30 June 2012, the public in Australia and New Zealand will be able to search a data base with information on adverse reactions to medicines. This will be prospectively populated with data from both countries.
Over the next 12 months TGA and Medsafe will deliver a common recalls portal for therapeutic products.
A common early warning system will also be delivered over the next 12 months to inform the public of potential safety issues concerning therapeutic products.
Over the next 12 months TGA and Medsafe will work together to review and reform the business process for the evaluation of over the counter medicines. A common approach to lodgement of applications, assessment, evaluation and registration in TGA and Medsafe will be the end result.
In early 2013 TGA and Medsafe will have established an integrated capability to conduct audits to assess good manufacturing practice (GMP). To this end, in early 2012, both organisations will commence sharing of GMP reports.

Media inquiries:

Paul Perry, Minister Plibersek's office, 0427 249 435

Peter McCardle, Minister Ryall's office, 0212 439 067

Fact sheet

28 June 2011

Why is ANZTPA being created?

On 20 June 2011 the Prime Ministers of New Zealand and Australia announced that the New Zealand and Australian Governments have agreed to proceed with a joint scheme for the regulation of therapeutic goods (for example, medicines, medical devices, and biologicals).

The creation of a joint regulatory scheme across both countries will safeguard public health and safety, while encouraging economic integration and benefitting industry in both countries.

Over time, the joint arrangements will be administered by a single regulatory agency, the Australia New Zealand Therapeutic Products Agency (ANZTPA), which will absorb the current regulators - Australia's Therapeutic Goods Administration and New Zealand's Medsafe.

New Zealand is introducing a separate scheme to regulate natural health products in the New Zealand Market.

How will the transition to a joint regulator be implemented?

A three-phase and staged approach over a period of up to five years will be adopted to progressively achieve the establishment of ANZTPA.

The two countries' regulators, Medsafe and the TGA, will immediately begin a programme of work-sharing and increased joint operations. This will enable the separate regulatory systems of each country to be enhanced by sharing of data and information, training, and establishing centres of expertise in each country.
Building on this, a single entry point for industry will be established and a common trans-Tasman regulatory framework will be agreed for therapeutic products (for example, medicines, medical devices and biologicals).

During these two preliminary phases, each country will retain its own regulator and continue to make its own regulatory decisions, but business will benefit from a significant reduction in red tape with only one set of requirements to operate in two countries.
As business operations become increasingly integrated and following a review of progress, the single regulator will be established.

When will ANZTPA start operations?

From July 2011, both countries will immediately begin to share resources, expertise and information, building the regulatory capacity in both countries.

A Transition Agency will be established to oversee implementation of the joint arrangements for medicines, devices and biologicals. This Transition Agency will advise a select Ministerial Council on the joint scheme, which will include the Australian and New Zealand Health Ministers and other relevant ministers.

Following a review of progress and final confirmation of arrangements, the separate national regulators will be absorbed into a new joint agency.

The new ANZTPA is expected to be operational within five years.

This approach to implementation will deliver prompt and progressive benefits for consumers, industry and governments.

What are the benefits of a single trans-Tasman regulatory system?

A single regulatory framework will provide health benefits for consumers, reduced regulatory costs for industry and greater efficiency for governments.

The new world class scheme is expected to enhance the reputation of New Zealand and Australian therapeutic products on the world market.

When did Australia and New Zealand originally agree to a joint therapeutic goods regulator?

Agreement for a joint regulatory scheme was first reached in 2003. However, the joint scheme was not able to proceed as New Zealand was unable to pass enabling legislation.

Negotiations between the countries were suspended in July 2007. However, the Treaty between Australia and New Zealand remained in place and allowed both countries to resume negotiations at any time.

Will all therapeutic products be regulated by ANZTPA?

The 2003 Treaty envisages a common regulatory framework for all therapeutic goods.

The 20 June 2011 announcement by the Prime Ministers of New Zealand and Australia acknowledges that the New Zealand Government will introduce a separate scheme to regulate natural health products in the New Zealand market; and that the establishment of ANZTPA is not dependent on natural health products being part of the joint regulatory arrangements. In the future, should both countries agree, it would be possible to include natural health products within the joint scheme.

A review of this proposed New Zealand scheme for natural health products in five years' time will consider whether or not to maintain a separate scheme for certain natural health products in New Zealand.

Until a common regulatory framework is agreed, all therapeutic goods to be supplied into the New Zealand or Australian markets will still need to meet the standards in these markets.

How will the new ANZTPA be funded?

Each country will be responsible for meeting the costs associated with the early phases of this joint ANZTPA work programme. Over time, the cost of regulation will be integrated into the cost recovery arrangements with industry. At this stage, TGA and Medsafe will continue their usual cost recovery arrangements from industry.