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29 Oct 2013 | Press Release

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ANZTPA Progress Welcomed By Dental Industry

Regulatory Affairs TGA

The ongoing commitment of dental product regulators to establish the Australia New Zealand Therapeutic Products Agency (ANZTPA) has been welcomed by the peak business organisation representing dental product manufacturers and suppliers, the Australian Dental Industry Association (ADIA).


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.

During the course of the past week industry stakeholders, including ADIA, were briefed by the TGA on the transition to ANZTPA and the proposed regulatory framework.

"The ANZTPA initiative is an important opportunity to reduce red tape. ADIA's focus is on using the reforms to secure a regulatory framework for dental products that is based on a risk management approach designed to ensure public health and safety, while at the same time freeing industry from an unnecessary regulatory burden," said Troy Williams, ADIA Chief Executive Officer.

The Australian and New Zealand Governments have committed to ANZTPA being operational by 2016 and there has been considerable progress towards meeting this objective.

"It was pleasing to receive advice that the ANZTPA regulatory framework associated with the premarket approval and post-market surveillance of dental products and other medical devices will be finalised during the course of 2014." Mr Williams said.

According to ADIA, ANZTPA will deliver benefits for patients.

"Using ANZTPA as an instrument to reduce the regulatory burden associated with the importation of dental products will reduce the current delays associated with introducing new dental products to the market place," Mr Williams said.

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