Australia's TGA to merge with NZ's Medsafe

It’s a fair bet that the Therapeutic Goods Administration is currently making like a duck. Although the regulator may present a calm front to the world, below the surface it is paddling like mad, preparing for a huge shift from life as a local regulator to that of a new trans-Tasman joint agency.

As the body responsible for the registration of medicines in Australia, the TGA calls the shots when assessing the safety, quality and performance of pharmaceuticals and medical devices -- and also biologics. At the end of 2003, the Australian and New Zealand governments signed a treaty in the New Zealand capital, Wellington, pledging to establish a single, bi-national agency. Due to open its doors in July 2005, the agency will replace the TGA and New Zealand’s Medsafe, and will be accountable to both governments. The single agency will include the regulation of medical devices and prescription, over-the-counter and complementary medicines.

When the treaty was signed, the Australian parliamentary secretary for Health, Trish Worth, outlined the ambit of the joint agency. “The administrative arrangements… will include the Office of the Gene Technology Regulator and the Office of Chemical Safety, which includes the National Industrial Chemicals Notification and Assessment Scheme, although these regulators will only operate in Australia," she said.

The move makes sense not only because so many products produced in either Australia or NZ are sold in the other country, but also because NZ recognised that it didn’t have the capacity or the technical expertise to evaluate increasingly complex and high-risk products.

The changes shouldn’t, however, ruffle many feathers either amongst the regulators or in the big companies that sell products in both Australia and NZ. A trans-Tasman mutual recognition agreement has smoothed the regulatory trading routes between Australia and NZ for some years, and for most goods an open market is already effectively in place.

There is the question of fees, however. Currently, Australian registration fees are much higher -- and a review of the disparities is due to reach an outcome at the end of October. New Zealand’s medical devices and complementary medicine sectors can expect to be hit with fees, and regulation, for the first time -- as both areas are currently unregulated.

Other possible hurdles for companies negotiating the new regulatory structure include patent expiration dates that are out of step and discrepancies between freedom of information legislation -- which is slightly different in each country.