Milestones of the ANZTPA project

June 2011

Recommencement
Statements by Australian Prime Minister - Julia Gillard and New Zealand Prime Minister John Key

• Landmark agreement to achieve world standards in therapeutic products
• Australia, NZ announce intention of ANZTPA

July 2007

Suspension

December 2003

"Agreement Between the Government of Australia and the Government of New Zealand for the Establishment of a Joint Scheme for the Regulation of Therapeutic Products" signed

March 2003

Final report of Advertising Review released.

December 2002

Both the New Zealand Cabinet and Australian Government agree to the establishment of a trans Tasman agency to regulate therapeutic products.

June 2002

Joint (Australia/New Zealand) Discussion Paper "A Proposal for a Trans-Tasman Therapeutic Agency to Regulate Therapeutic Products" released

July 2001

Australian Government agreed in principle to the establishment of a joint trans-Tasman agency to regulate therapeutic products.

December 2000

New Zealand Cabinet agreed in principle to the establishment of a joint trans-Tasman agency to regulate therapeutic products, subject to negotiation of governance arrangements satisfactory to New Zealand.

October 2000

Consulting company New Zealand Institute of Economic Research carried out a Regulatory Impact Analysis with respect to the proposed trans-Tasman regulator compared with a system that allows unilateral recognition by New Zealand of some other countries' regulatory decisions, and an analysis of the costs and benefits for Australia of setting up the proposed joint agency against the status quo.

June 2000

Joint (Aus/NZ) consultation paper released to stakeholder groups on a possible framework for a joint trans-Tasman agency to regulate therapeutic products.

May 2000

Australia established a Regulatory Reform Taskforce to review Australia's administrative arrangements for the regulation of public health and safety.

1999

New Zealand and Australian Health Ministers agreed that harmonisation of regulatory requirements for therapeutic products is likely to be the best option under the Trans-Tasman Mutual Recognition Arrangement (TTMRA). The Health Ministers, with their Trade and Commerce Minister colleagues, agreed that a project to explore the viability of establishing a joint trans-Tasman therapeutics regulator should be given priority on the TTMRA work programme.

May 1998

Trans-Tasman Mutual Recognition Act 1997 came into force. Special exemption applied to therapeutic products.

May 1993

Memorandum of Understanding signed between the TGA (Australia) and Medsafe (NZ) covering information exchanges and cooperation between the two regulators.