Australia and New Zealand move closer to joint regulation of medicines and medical devices

On Monday, the Prime Minister Julia Gillard, and her New Zealand counterpart John Key, announced that both countries had signed a statement of intent to create a joint authority to regulate medicines and medical devices in both countries.

The new authority, the Australia New Zealand Therapeutic Products Agency (“ANZTPA”), is intended to replace Australia’s Therapeutic Goods Administration (“TGA”) and New Zealand’s Medsafe within five years. It

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will be responsible for the regulation of medicines, medical devices and other therapies such as tissue and cellular therapies. However, natural health products in New Zealand will continue to be regulated separately.

According to the TGA, the scheme will be implemented in three phases:

1) starting in July, the TGA and Medsafe will begin work sharing arrangements and joint operations to align their practices and share information, resources and expertise;

2) continuing integration to establish a single entry point for industry and the development of a trans-Tasman regulatory framework; and

3) the establishment of the single regulator within the next five years.

Click here to see the TGA’s announcement.

If eventually implemented, industry would benefit in a number of ways. Most obviously, there would be a single entry point for sponsors with reduced licensing and approval costs. Combined with benefits to the ANZTPA (such as better consistency in standards and a shared workload), this should result in faster approvals and improved regulation for therapeutic goods in both countries.

About the Author

James Ellsmore
James is a senior associate with King & Wood Mallesons' Intellectual Property team in Sydney. James assists clients to resolve intellectual property disputes, with a particular focus on patents, pharmaceuticals and the life sciences. He has acted for a variety of clients in matters concerning patent infringement and revocation proceedings in the Federal Court of Australia, patent opposition proceedings before the Commissioner of Patents, and matters arising from patent licence and technology agreements. James also has experience in the preparation of commercial, R&D and IP agreements for leading universities, research organisations and pharmaceutical companies. He also advises clients on regulatory issues affecting clients in the industrials, consumer and health sectors.
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