New Zealand to Overhaul Regulatory System, Will Rely on Other Regulators' Approval of 'Cutting Edge' Products
Posted 20 May 2016 | By
The government of New Zealand is working to completely overhaul its regulatory system for healthcare products by drafting new legislation to replace the country's Medicines Act of 1981.
The major changes being proposed are intended to modernize New Zealand's regulatory system by making it more flexible and efficient, while filling in "significant gaps in coverage" for medical devices and cell and tissue therapies.
The plan would also allow New Zealand to recognize the approval of "cutting-edge" products in other countries as a means of improving access to innovating new products until its regulators gain the capacity to assess such products themselves.
However, the plan recognizes that the country would suffer "reputational damage from being seen as a free-rider," and states that "New Zealand should maintain a full-service regulator for medicines."
The announcement comes two years after New Zealand and Australia abandoned their decades-long effort to establish a joint regulatory authority, the Australia New Zealand Therapeutic Products Agency (ANZTPA).
In November 2015 and March 2016, New Zealand's Cabinet met to review a series of discussion papers drafted by the Ministry of Health that outlined the government's plans for the new regulatory regime. In late April, the Ministry of Health released the papers to the public for the first time.
According to the papers, the objectives are to make sure the new regulatory system:
- Meets expectations of risk management and assurance of acceptable safety;
- Results in efficient and cost effective regulation;
- Is flexible, durable, up-to-date, and easy to use;
- Ensures high-quality, robust and accountable decision-making;
- Is able to sustain capable regulatory capacity;
- Supports New Zealand trade and economic objectives;
- Is trusted and respected; and
- Supports consumer access and individual responsibility for care.
The Ministry of Health currently expects the bill to be introduced in late 2016 and passed into law some time in 2017.
New Zealand Ministry of Health