Regulatory Focus™ > News Articles > As Oceanic Regulator ANZTPA Comes Online, Harmonization Efforts Yield Results

As Oceanic Regulator ANZTPA Comes Online, Harmonization Efforts Yield Results

Posted 12 February 2014 | By Alexander Gaffney, RAC

The regulatory systems of Australia and New Zealand have been slowly merging over the last few years, with the stated end goal of being able to provide better regulatory services at a lower cost to the taxpayers of each respective country.

The Australia New Zealand Therapeutic Products Agency (ANZTPA), as the merged agencies will be called, has slowly been making note of its milestones over the last few years as it builds its regulatory capacities up and out.

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; and in March 2013, it proposed a new parallel drug and device monitoring system.

All of which is to say ANZTPA has been busy, and especially with planning.

But now the regulatory agency has announced another first: its first completed harmonization activity.

The harmonization effort focused on two fairly standard medications, paracetamol (also known as acetaminophen) and ibuprofen, which had different pediatric dosage instructions in Australia and New Zealand.

Under the harmonization effort, New Zealand adopted Australia's pediatric dosing instructions, which it said will "minimize the potential for confusion due to differing label advice about appropriate dosages."

"The changes … follow a review of the dosage instructions for paediatric liquid preparations in use in the UK, Australia and Canada," ANZTPA explained. "The doses are consistent with those set out in the New Zealand Formulary for Children launched on 20 November 2013."

The new recommendations may be found in the labeling statements database of Medsafe, New Zealand's regulator.

 

ANZTPA Statement


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe