Steady progress toward the Australia New Zealand Therapeutic Products Authority
Therapeutic Products Interim Ministerial Council
11 December 2005
The New Zealand Minister of State Services, Annette King and Australia’s Parliamentary Secretary for Health, Christopher Pyne met in Canberra last week to review the steady progress being made to establish a joint therapeutic products regulatory scheme.
Confirming that the title of the new agency will be the Australia New Zealand Therapeutic Products Authority, Ms King and Mr Pyne said that settling on a name is another tangible step towards the physical establishment of the Authority.
The new Authority will replace Australia’s Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe). Its role will be to safeguard public health and safety in both Australia and New Zealand, through regulation of therapeutic products including prescription and over-the-counter medicines, complementary medicines, medical devices and blood products.
Following the Interim Ministerial Council Meeting today, Ms King and Mr Pyne said that the Rules of the new scheme will be ready for consultation in early 2006, with consultation on the legislation to commence mid-year.
"Industry is keenly interested in the detail of the regulatory scheme arrangements that will be set out in Rules and we look forward to these groups providing their comments and input before the legislation is finalised. The Rules consultation will occur over the first half of 2006," they said.
After this time it is proposed that the legislation will be introduced to the New Zealand parliamentary system and released as an exposure draft for industry consultation in Australia. In both countries this will signal the beginning of formal consultations with interested parties on the legislation.
"This will mean that the start up date for the new Authority, scheduled for 1 July next year, will need to be deferred," Ms King and Mr Pyne said.
"This will allow us to embark on an extensive consultation program to enable industry, in particular, to review and comment on the legislation and rules for the new Authority," they said.
Ms King and Mr Pyne also announced today the appointment of Philip Davies, as the Transitional Director for the Joint Agency Establishment Group. Mr Davies has held senior positions in both the New Zealand Ministry of Health and the Australian Department of Health and Ageing and will report to these organizations in his new role.
"Mr Davies’ role will be to begin the transition and culture change as the two countries move under the joint Authority," they said.
"The role is time-limited and supplements the resources of the existing management team through to the establishment of the Authority. In the lead-up to the Authority’s formal launch, an international recruitment firm will be engaged to assist in the recruitment of a Managing Director to lead the Authority once it becomes operational."
More information on the proposed Authority can be found at www.anztpa.org.
Media inquiries:
John Harvey, Ms King’s Office, (64) 4 470 6851
Adam Howard, Mr Pyne’s Office 0400 414 833
Kay McNiece, TPIMC Secretariat 0412 132 585