In December 2003, the New Zealand and Australian Governments agreed to establish a joint Trans Tasman Agency (ANZTPA) to regulate therapeutic products in both countries. Therapeutic products include prescription and over the counter medicines, medical devices, complementary medicines, blood products and cellular and tissue therapies.
Role of the Agency
The role of the Agency will be to safeguard public health and safety through regulation of the quality, safety and performance of therapeutic products.
A risk based approach will be taken so that the level of regulation is commensurate with the level of risk associated with the products.
Accountability of the Agency
The Agency will be accountable to both the New Zealand and Australian Governments and be recognised in law in both countries.
The implementing legislation in New Zealand will be introduced to Parliament in July 2006. This legislation will be called the “Therapeutic Products Bill.”
Regulatory activities of the Agency
- Premarket evaluation and assessment
- Product licensing of manufacturers and distributors
- Maintaining a national register of manufacturers and distributors
- Post market monitoring and surveillance
- Setting quality standards
The Agency will ultimately replace:
- TGA (Therapeutic Goods Administration) in Australia
- MEDSAFE (NZ Medicines & Medical Devices Safety Authority) in New Zealand
Benefits to New Zealand Consumers
1. Regulation of medical devices
At present, regulation of medical devices in New Zealand is out of step with the rest of the world because there is no requirement for products to meet minimum standards of safety, quality and performance. This inadequate regulation leaves New Zealand open to becoming a dumping ground for substandard product that cannot be marketed in other countries that apply international best practice standards. This absence of adequate regulation exposes users of medical devices to an unacceptable level of risk and exposes the health sector to the costs of remedial action when defective products fail and users are harmed.
2. Ability to trace and recall defective medical devices effectively
Prior to 1 January 2004, there was no database for medical devices and their suppliers in New Zealand. This limited the ability of MEDSAFE (NZ Medicines & Medical Devices Safety Authority) to trace and recall defective products quickly.
On 1 January, 2004, the Medicines (Database of Medical Devices) Regulations 2003 came into force, initiating the commencement of a medical device database in New Zealand. What this means is that every New Zealand based person, organisation, company or hospital that manufacturers or imports medical devices for supply in New Zealand must enter details into a database within 30 days of commencing supply.
Single use examination gloves are classified as a Class 1 medical device. Fine Touch Disposables has complied with the legal requirements of the Medicines Regulations 2003 and recorded the latex, nitrile and vinyl gloves supplied to the New Zealand medical market on the MEDSAFE database.
3. Reduces compliance costs by replacing current dual regulatory
4. Strengthens New Zealand’s regulatory capacity
