Australia and New Zealand outline plans for joint regulatory agency

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Australia and New Zealand outline plans for joint regulatory agency

INICIO/Políticas y legislación | Posted 30/09/2011 0 Post your comment

The Australian and New Zealand governments have agreed to proceed with a joint scheme for regulation of therapeutic goods, i.e. medicines, medical devices, etc. 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 – Australian Therapeutic Goods Administration (TGA) and New Zealand’s Medsafe.

The two agencies say that a single regulatory framework will provide health benefits for consumers, reduced regulatory costs for industry and greater efficiency for the governments of Australia and New Zealand.

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.

However, concerns have been expressed by Medicines Australia, which represents the pharmaceutical industry in Australia, that the extra workload for the TGA due to setting up this joint agency may further delay extensive reforms which are intended to ensure more timely access to new medicines for Australians.

Acting Chief Executive of Medicines Australia, Mr Andrew Bruce, said that ‘it is extremely important that those reforms are not adversely impacted or delayed by extra workload associated with establishing ANZTPA.’

Starting from July 2011, both countries will start 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. 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 the new joint agency.

The new ANZTPA is expected to be operational by 2016.

Initially each country will be responsible for meeting the costs associated with the early phases of this joint ANZTPA work programme. However, by 2016 the cost of regulation is expected to be integrated into the cost recovery arrangements with industry.

Source: Medicines Australia, Medsafe, TGA