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Tim Vines
Manager Therapeutics Policy Team Manatū Hauora, The Ministry of Health Tim moved to Aotearoa New Zealand from Canberra, Australia in 2019, having spent the previous 10 years working in the Australian Public Service. In Australia, Tim led a number of projects at the National Health and Medical Research Council (Australia’s main public funder of health and medical research) involving clinical trials policy, the development of the national Human Research Ethics Application system, and the establishment of the Australian Research Integrity Committee.
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The Therapeutic Products Act and the Road to 2026
On 19 July 2023, the Therapeutic Products Bill passed its third and final reading in Parliament. Soon to be enacted as the Therapeutic Products Act 2023, the Act marks the most significant change to the regulation of medicines, medical devices and natural health products in nearly 40 years. The Act will also change how certain ‘controlled activities’ involving therapeutic products, including clinical trials, are regulated. While the Act will result in some change for researchers, supporting research and innovation remains an imperative.
Most of the Act’s provisions will not commence until 2026, to allow for the development of secondary legislation and the establishment of the new regulator. During this time, Manatū Hauora will consult with the sector on the design of regulations that apply to clinical trials and innovative products.
During this session, Tim Vines will provide an overview of the relevant parts of the new Act, respond to some matters raised by the sector in submissions to the Health Committee and outline the steps along the road to the commencement of the new regime in 2026. This session will also provide an opportunity for attendees to raise their priorities for the new regime.
On 19 July 2023, the Therapeutic Products Bill passed its third and final reading in Parliament. Soon to be enacted as the Therapeutic Products Act 2023, the Act marks the most significant change to the regulation of medicines, medical devices and natural health products in nearly 40 years. The Act will also change how certain ‘controlled activities’ involving therapeutic products, including clinical trials, are regulated. While the Act will result in some change for researchers, supporting research and innovation remains an imperative.
Most of the Act’s provisions will not commence until 2026, to allow for the development of secondary legislation and the establishment of the new regulator. During this time, Manatū Hauora will consult with the sector on the design of regulations that apply to clinical trials and innovative products.
During this session, Tim Vines will provide an overview of the relevant parts of the new Act, respond to some matters raised by the sector in submissions to the Health Committee and outline the steps along the road to the commencement of the new regime in 2026. This session will also provide an opportunity for attendees to raise their priorities for the new regime.
