Progress on Aust/NZ Therapeutic Products Authority
The Australian and New Zealand governments have moved closer towards establishing an Australia New Zealand Therapeutic Products Authority (ANZTPA). The aim of the proposed joint regulatory scheme for therapeutic products is to protect the health and safety of Australians and New Zealanders by regulating the safety, quality and effectiveness of prescription and over-the-counter medicines, complementary medicines, medical devices, tissue and cellular therapies, blood and blood products in both countries.
More than 1,000 industry, and other stakeholders and consumers have met in a round of public consultation meetings in New Zealand and Australia. This was followed up by a recent Ministerial meeting in New Zealand.
This meeting considered the plans for the second phase of consultation on the proposed joint regulatory scheme, expected to begin in mid-September 2006. This will include the release of the draft advertising rule, draft rule for blood and blood components, and the further aspects of the draft administration rule, such as scheduling.
The Ministers agreed in principle to the use of third parties for conformity assessment for Australian and New Zealand manufacturers of medical devices, with the ANZTPA making the licensing decision.
The ministerial meeting ratified the appointment of the chair, deputy chair and membership of a new Advertising Implementation Steering Group. The steering group will provide guidance on proposals for the joint regulation of the advertising of therapeutic products under the proposed Authority.
Former Liberal Senator Sue Knowles has been appointed as the chair of the steering group. She was a key member of Australia’s Senate Community Affairs Legislation Committee. Ms Knowles gained an extensive understanding of health, aged care, Indigenous health, welfare and related matters.
The Interim Ministerial Council also received an update on the regulatory framework for human cellular and tissue therapies, which would be regulated under the proposed ANZTPA. It was noted that consultation with stakeholder groups is currently under way to further develop the detail of the proposed regulatory scheme for human cellular and tissue therapies.
For information visit www.anztpa.org
