Australia, New Zealand to Establish Joint Medical Device Regulator

The governments of Australia and New Zealand are setting up a single regulatory body to oversee therapeutic goods including medical devices and pharmaceuticals across both their countries.

The new entity, the Australia New Zealand Therapeutic Products Agency (ANZTPA), will replace Australia’s Therapeutic Goods Administration (TGA) and New Zealand’s Medsafe—a move which both governments argue will further economic integration, benefit industry and more efficiently uphold public health.

The transition to ANZTPA will occur over a five-year, three-stage process. First, TGA and Medsafe will set up a work-sharing program and expand their joint operations. Second, the regulators will set up a single point of entry and regulatory framework for industry. Finally, ANZTPA will be formally launched.

The first stage of the transition will begin in July 2011; a transition agency including Australian and New Zealand health ministers will oversee all phases of the transition to ANZTPA.

In terms of funding, TGA and Medsafe will keep in place their current cost recovery schemes with industry during the early stages of the transition; eventually, regulatory costs will be folded into costs recovery arrangements with industry.

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