Plans for a joint A/NZ regulator called off

The Australian and New Zealand governments have called off plans to establish a joint therapeutic products regulator due to cost-benefit concerns.

The plan by the health ministries of the two countries to establish the Australia New Zealand Therapeutic Products Agency (ANZTPA) has been taken off the table.

In a joint statement, Australian Health Minister Peter Dutton and New Zealand Health Minister Jonathan Coleman said the decision was taken “following a comprehensive review of progress and assessment of the costs and benefits to each country of proceeding”.

But the two countries will continue to cooperate on the regulation of therapeutic products, with the TGA and New Zealand’s Medsafe to explore other regulatory harmonisation activities.

These include a new information-sharing agreement, mutual recognition of good manufacturing practice audits, as well as efforts to reduce the compliance costs of trans-Tasman applicants.

Both Australia and New Zealand also plan to continue independently with their own regulatory reform programs, and both ministers will continue to cooperate through a bilateral agreement. New Zealand will continue to participate in the Council of Australian Governments health council.

ANZTPA was originally intended to replace both the TGA and Medsafe. Plans to establish the joint agency had been in the works since 2011.