The Australian and New Zealand governments further progressed their
commitment to the establishment of the Australia New Zealand Therapeutic
Products Authority (ANZTPA) at an Interim Ministerial Council meeting
in Wellington recently.
At the meeting the New Zealand Minister for State Services, Annette
King, and the Australian Parliamentary Secretary for Health, Christopher
Pyne, covered a range of issues including the importance of consultation
The aim of the proposed joint regulatory scheme for therapeutic products
is to protect the health and safety of Australians and New Zealanders.
It will do this by regulating the safety, quality and effectiveness
of prescription and over-the-counter medicines, complementary medicines,
medical devices, tissue and cellular therapies, and blood and blood
products in both countries.
" Consultation is crucial in ensuring the new regulatory
scheme meets the overall objective of safeguarding public health
and safety," Ms
" It is an opportunity for industry, other stakeholders
and consumers to provide input into how the scheme will operate."
Mr Pyne said that in June this year the first round of public consultation
meetings were held in New Zealand and Australia.
" They were attended by more than 1000 people as part of
the ongoing consultation process with stakeholders," Mr
" We are also pleased that many stakeholders took the opportunity
to make submissions during this first phase of public consultation,
which included consideration of the draft rules for medicines and medical
At the ministerial meeting, Ms King and Mr Pyne also considered the
plans for the second phase of consultation on the proposed joint regulatory
scheme, expected to begin in mid-September 2006. This phase 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.
Ms King and Mr Pyne also 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
" Sue Knowles, formerly an Australian senator, has been
appointed as the chair of the steering group," Mr Pyne
" As 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."
" Tony Miller, the chief executive of
New Zealand's Self Medication Industry Association, will also bring
extensive experience to the role
of deputy chair," Ms King said.
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.
More information about the proposed trans-Tasman joint regulatory
scheme, along with details about the current consultation phase and
how to make a submission, can be found on the Australia New Zealand
Therapeutic Products Authority website: www.anztpa.org.