Harmonisation for Australia and NZ on the Horizon

Positive news for therapeutic goods manufacturers as the Australian and New Zealand Governments agree to resume plans for a joint scheme for regulation of therapeutic goods. The joint scheme will reduce regulatory burden for industry in both Australia and New Zealand.

Agreement for a joint regulatory scheme was first reached in 2003. However, the joint scheme was not able to proceed as New Zealand was unable to pass enabling legislation.  Negotiations between the countries were suspended in July 2007. However, the Treaty between Australia and New Zealand remained in place and allowed both countries to resume negotiations at any time.

With talks finally recommenced, it is believed the planned joint arrangements will be administered by a single regulatory agency, the Australia New Zealand Therapeutic Products Agency (ANZTPA), meaning the current regulators – Australia’s TGA and New Zealand’s Medsafe will no longer independently exist.

ANZTPA will come to fruition through a 3 staged approach expected to take up to 5 years to complete. The 3 steps are described below, along with the implications for therapeutic goods manufacturers:

• Stage 1: From July 2011 the TGA and Medsafe will begin a program of work-sharing and increased joint operations. This will enable the separate regulatory systems of each country to share data and information, training, and will also assist to establish centres of expertise in each country.
• Stage 2: Building on stage 1, stage 2 will see a single entry point for industry established and a common trans-Tasman regulatory framework agreed upon.

During these two preliminary stages, therapeutic goods manufacturers will significantly benefit from a reduction in red tape with only one set of requirements in both countries, despite each country retaining its own regulator and continuing to make independent regulatory decisions.

• Stage 3: As operations become increasingly integrated and a following a review of progress, the single regulator, ANZTPA, will be established.

The TGA are hopeful that the new world class scheme will enhance the reputation of Australian and New Zealand therapeutic goods on the world market.

No formal dates have been given for the implementation of each phase. Stay tuned for further news in the upcoming months…

For information regarding KD&A’s services for Australian and/or New Zealand please visit the product registration page or contact us.