18 October 2006
Consultation continues on the proposed trans-Tasman regulatory scheme for therapeutic products
A second phase of consultation on the proposed trans-Tasman regulatory scheme for therapeutic products is now underway and feedback is being invited.
Australia and New Zealand are working together to set up a world-class joint regulatory scheme for complementary medicines, over-the-counter and prescription medicines, medical devices, blood and blood products and tissues and cellular therapies.
The transitional director of the Joint Agency Establishment Group, Mr Philip Davies, says the aim is to develop a regulatory scheme that better protects the health and safety of consumers who use therapeutic products in both Australia and New Zealand.
“It’s proposed that the Australia New Zealand Therapeutic Products Authority (ANZTPA) would do this by regulating the quality, safety and effectiveness or performance of therapeutic products both before and after they enter the marketplace,” Mr Davies said.
As part of the development of the joint scheme, submissions are now being invited on technical details of the proposed joint regulatory scheme for:
- The proposed medicines scheduling provisions of the draft Administration and Interpretation Rule
- The proposed regulation of Blood under ANZTPA
- The proposed Product Vigilance arrangements under ANZTPA
“Significant and ongoing consultation on the proposals is crucial in the development of a joint regulatory scheme which is workable and meets the overall objectives of protecting public health and safety in both countries, Mr Davies said.
“This year we have moved into an intensive phase of consultation on the proposed joint regulatory scheme in the lead up to the establishment of the joint Authority,” Mr Davies said.
“It is important to emphasise that we are consulting on draft Rules and consultation documents and we are genuinely seeking constructive comments and suggestions that will be considered as part of the development of the joint regulatory scheme,” Mr Davies said.
The consultation documents can be download from the ANZTPA website at:
Submissions close on 6 December 2006.
Questions and Answers:
What consultation documents have been released?
- The proposed medicines scheduling provisions of the draft Administration and Interpretation Rule, which details the proposed scheduling processes for medicines under the Australia New Zealand Therapeutic Products Authority (ANZTPA).
- A consultation paper on the proposed regulation of blood under the ANZTPA. Submissions received on this consultation paper will be used to inform the development of the draft Rule for the regulation of blood.
- A Consultation Paper on Product Vigilance, which sets out the proposed pharmacovigilance and medical device vigilance (product vigilance) functions of the ANZTPA.
Accompanying resource documents including a Plain English Guide to the proposed medicines scheduling provisions of the draft Administration and Interpretation Rule and a copy of a proposed ANZTPA Product Licence are also available from the ANZTPA website at: http://www.anztpa.org/consult/consdocs2.htm
When do submissions close?
Submissions on the consultation documents close on 6 December 2006. The submissions will then be analysed jointly by New Zealand and Australian officials from Medsafe, the Ministry of Health, the Therapeutic Goods Administration and the Department of Health and Ageing.
What other consultation is being undertaken?
During 2006/07 there will be a phased release of documents for public consultation. This will include the draft Ministerial Council Rules, which contain the detail of the proposed joint regulatory framework for therapeutic products, and the key draft Managing Director’s Orders which define specific technical standards. Consultation on the draft Rules and key draft Orders will occur in three substantive phases from May 2006, October 2006 and March 2007.
Will there be consultation on the Australian and New Zealand Bills?
Public consultation on the New Zealand Bill and the Australian Bill will take place as part of the Parliamentary processes of each country. In New Zealand, the New Zealand Bill will be available for submissions as part of the Select Committee process. In Australia, public feedback will be invited with the release of an Exposure draft of the Australian Bill.
What are therapeutic products and why do we need to regulate them?
Therapeutic products include complementary medicines such as dietary supplements and herbal medicines; over-the-counter medicines and prescription medicines; medical devices such as contact lenses, condoms, hearing aids, heart valves, pace makers and endoscopes. Blood and blood products and cellular and tissue therapies are also examples of therapeutic products.
It is important to regulate pre and post market safety, quality and effectiveness of these products so that consumers' are assured that their health and safety is protected.
What is the ANZTPA?
The proposed Australia New Zealand Therapeutic Products Authority or ANZTPA is the name that has been given to the agency which will jointly regulate therapeutic products in Australia and New Zealand. Once established, it will replace Australia's Therapeutic Goods Administration (TGA) and the New Zealand Ministry of Health's Medicines and Medical Devices Authority, Medsafe. The Authority's work would include pre-market evaluation and assessment of therapeutic products; product licensing; controls on manufacture; post-market monitoring and surveillance; and standards setting.
Why do Australia and New Zealand need a joint regulatory scheme for therapeutic products?
It is the best way to ensure both countries are able to update their legislation and to provide sustainable therapeutic products regulation that meets international guidelines, benchmarks and recommendations into the future. The proposed Australia New Zealand Therapeutic Products Authority will also help to open the door for greater trans-Tasman trade opportunities and enhance Closer Economic Relations between Australia and New Zealand. It is also likely to lead to closer cooperation with regulators in the wider Asia-Pacific region.
Will both countries have a say in the setting up and running of the joint Authority?
The Australian and New Zealand Governments will have equal say in the joint Authority, and a shared responsibility for the way it is run. The Authority would have similar accountability to a Crown Owned Entity in New Zealand or a Commonwealth Authority in Australia. It will be overseen by a five member board which will be accountable to the Authority’s two-member Ministerial Council, comprising the Health Ministers of both Australia and New Zealand.
What is the Joint Agency Establishment Group?
The Joint Agency Establishment Group (JAEG) was set up in April 2004 and is made up of officials from Australia's Therapeutic Goods Authority and the New Zealand Ministry of Health Medicines and Medical Devices Safety Authority, Medsafe. The joint establishment project group is overseen by the transitional director, Mr Philip Davies.
Where can I find further information?
Further information is available on the project website at: http://www.anztpa.org/
Frequently Asked Questions about aspects of the scheme can be found at: http://www.anztpa.org/qa.htm
Information about the consultation programme is available at: http://www.anztpa.org/consult/programme0607.htm