Regulatory Focus™ > News Articles > Oceania Regulator ANZTPA Shut Down by Australia and New Zealand

Oceania Regulator ANZTPA Shut Down by Australia and New Zealand

Posted 20 November 2014 | By Alexander Gaffney, RAC

Oceania Regulator ANZTPA Shut Down by Australia and New Zealand

Australian and New Zealand officials have confirmed they plan to stop development of the Australia New Zealand Therapeutics Products Agency (ANZTPA), a joint regulatory authority meant to more efficiently regulate healthcare products in both countries.

Background

The ANZTPA has been under development since at least 2011, and had reached several notable milestones since 2012. In September 2012, it put out a call to harmonize over-the-counter drug regulations, and completed that harmonization by March 2013. In November 2012, it launched a new dedicated website; in November 2013, it announced a massive harmonization effort focused on 14 separate activities; in March 2013, it proposed a new parallel drug and device monitoring system; and in June 2013 it launched a new joint adverse event notifications system.

Though progress on the merger of the two regulatory bodies—Australia's Therapeutic Goods Administration (TGA) and New Zealand's Medsafe—had been slower than anticipated, both regulators said they hoped to have ANZTPA fully operational by 2017. That goal was on track as of November 2012, regulators had said.

Effort Scrapped

But despite recently completing its first harmonization activity, Australian and New Zealand officials have now decided to end the ANZTPA effort, saying a "comprehensive review of progress and [an] assessment of the costs and benefits to each country" had concluded the effort was no longer worth pursuing.

"While work on ANZTPA will cease, our two countries will continue to co-operate on the regulation of therapeutic products where there are mutual benefits for consumers, businesses and regulators in each country," the two countries said in a joint statement.

Both TGA and Medsafe will continue to pursue "other trans-Tasman regulatory harmonization activities," they said.

For now, it's unclear what will become of ANZTPA's existing harmonization efforts, including its joint recall portal or adverse event reporting portal.

 

ANZTPA Statement


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