Australia-NZ Therapeutic Products Authority Closer
Joint Agency Establishment Group for the
Australia New Zealand Therapeutic Products Authority
27th March 2006
New Australia-New Zealand Therapeutic Products Authority a Step Closer
A schedule of consultation events to be held in both Australia and New Zealand was released today in the lead up to the establishment of the new Australia New Zealand Therapeutic Products Authority (ANZTPA).
ANZTPA will be a joint, trans-Tasman agency with responsibility for regulating therapeutic products across both countries. When established, it will replace Australia’s Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe)
The transitional director of the Joint Agency Establishment Group for the ANZTPA, Philip Davies, said today that consulting widely with industry, consumers and other interested parties was a key priority of both governments in the development of the new Authority.
“Industry needs to have every opportunity to review and comment on the details of the new regulatory system and time to put in place appropriate transitional arrangements, including staff training” Mr Davies said.
“Equally, consumers and their health practitioners in both countries need to feel assured that any new regulatory system will continue to protect their health and well being and we expect that consumer groups will welcome the opportunity to attend the proposed consultation sessions to gain information and to make comment.”
Mr Davies said the new Authority will regulate the quality, safety and efficacy of prescription and over the counter medicines, complementary medicines, medical devices, blood products and cellular and tissue therapies in both Australia and New Zealand.
“In undertaking this function, the Authority will be accountable to both the Australian and New Zealand Governments and be recognised in law in both countries,” he said.
Consultation sessions on the rules of the new agency will begin in New Zealand and Australia in June this year and will occur in three phases.
Written submissions will be sought and to assist stakeholders to prepare these, information sessions will be held during each phase to provide interested people with an overview of the documents being considered and to answer questions.
“Phase one of the consultation program will focus on the draft rules for medicines and medical devices, and the arrangements for fees and charges,” Mr Davies said.
“Phase two will focus on the draft rules for advertising, blood and blood components and scheduling.
“The final consultation phase will cover technical topics consulted on previously regarding the development of standards through joint interim expert committees.”
The implementing legislation (Therapeutic Products Bill) is expected to be introduced to Parliament in New Zealand in July 2006. Consultation on the Bill will occur as part of the Parliamentary process during Select Committee consideration of the Bill. An exposure draft of the Australian Bill will be released for consultation in July 2006, prior to introduction to Parliament in Australia.
More information about the proposed Australia New Zealand Therapeutic Products Authority (ANZTPA) and the consultation schedule can be found on www.anztpa.org