Overview of the proposal to establish a trans-Tasman regulatory scheme for therapeutic products
Australia and New Zealand – working together to safeguard public health and safety both now and into the future
Fact sheet
January 2007
What is the Australia New Zealand Therapeutic Products Authority establishment project?
Australia and New Zealand are working together to establish a trans-Tasman regulatory scheme for therapeutic products under a new agency known as the Australia New Zealand Therapeutic Products Authority (ANZTPA).
The proposed joint regulatory scheme would regulate the quality, safety and effectiveness or performance of therapeutic products including their manufacture, supply, import, export and promotion.
Wide consultation on the proposals has and continues to be undertaken to ensure the new scheme is workable and meets the overall objective of safeguarding public health and safety.
What is the aim of the proposed joint regulatory scheme?
The overall aim of the proposed joint regulatory scheme is to safeguard the health and safety of Australians and New Zealanders who use and consume therapeutic products.
It would do this by regulating the pre and post market safety and quality of therapeutic products including:
- complementary medicines such as herbal medicines, homoeopathic medicines, traditional medicines, aromatherapy products, vitamins, minerals and nutritional supplements;
- over-the-counter medicines;
- prescription medicines;
- medical devices;
- blood and blood products and tissues and cellular therapies.
Why is a joint regulatory scheme the best approach for Australia and New Zealand?
New Zealand's existing therapeutic products law is outdated and unsustainable and does not adequately manage the public health risks associated with the use of medical devices and complementary medicines. In addition, the Australian and New Zealand Governments have agreed that harmonisation of the regulatory requirements for therapeutic products and the establishment of a joint regulatory scheme is the preferred way of resolving the special exemption for therapeutic goods under the Trans Tasman Mutual Recognition Arrangement (TTMRA).
Therapeutic goods are the subject of a special exemption because of the significant differences in the way they are regulated in New Zealand and Australia.
What are the benefits of the proposed joint regulatory scheme?
Australia and New Zealand believe setting up a joint regulatory scheme for therapeutic products is the best approach for ensuring the continued safeguarding of public health and safety in a way which meets international best practice benchmarks, in the most cost effective way.
Aligning the two countries therapeutic products regulations would:
- enable New Zealand's out dated therapeutic products legislation to be modernised;
- harmonise the regulation of therapeutic products in Australia and New Zealand including complementary medicines and medical devices, in line with international best practice models;
- provide for an internationally recognised therapeutic products regulatory "stamp of approval" that would facilitate export into overseas markets and open up trans-Tasman trade opportunities;
- establish a new internationally recognised regulator of therapeutic products on the world stage.
What type of regulatory framework is being proposed?
The proposed joint regulatory scheme is based on categories or scales of risk. In simple terms this means that a lighter level of regulation would apply for lower risk therapeutic products, including most complementary medicines.
Tighter regulations would apply for higher risk therapeutic products such as prescription medicines and some medical devices such as pace makers and heart valves.
The proposed joint regulatory scheme will require:
- pre-market assessment of therapeutic product safety, quality and effectiveness;
- licensing of manufacturers to assure product quality;
- standards setting to assure product quality and performance;
- post-market monitoring of product safety and quality; and
- surveillance to check for compliance.
What is different about these proposals?
The main differences for New Zealand include:
- most dietary and nutritional supplements, including vitamins and minerals would be regulated as complementary medicines rather than as foods under the food legislation and would be required to meet criteria for safety and quality. Sponsors of complementary medicines would also need to hold evidence to support any therapeutic claims made for their products;
- medical devices would be regulated as therapeutic products and would be required to meet standards for safety, quality and performance.
The main differences for both New Zealand and Australia include that manufacturers and suppliers would be able to apply to the Authority to gain one product licence which would provide access into both the Australian and New Zealand markets.
How are therapeutic products currently regulated in Australia and New Zealand?
Currently, in New Zealand, therapeutic products are primarily regulated under the outdated Medicines Act 1981 and Medicines Regulations 1984. In Australia, therapeutic products are regulated under the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002. It is proposed that this legislation will be replaced by new legislation that will cover the regulation of therapeutic products in both countries.
Parts of New Zealand's existing medicines law will not form part of the joint scheme with Australia and will remain as New Zealand-specific medicines law. This legislation will cover aspects such as prescribing, dispensing and licensing of wholesalers.
Where can I find more information?
Further information about the Australia New Zealand Therapeutic Products Authority, including copies of current consultation documents can be found at: http://www.anztpa.org/
URL: http://www.anztpa.org/about/fs-overview.htm