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James Caldwell
Senior Policy Analyst, Transformation Team, Sector and Services Policy, Strategy and Policy, Ministry of Health, Wellington, NZ |
James Caldwell is a Senior Policy Analyst at the Ministry of Health. He has a background in both international relations and trade policy and regulatory policy for therapeutic products in New Zealand. This has included leading work on the administrative arrangements for ANZTPA and involvement in a number of free trade agreement negotiations. In 2012, he assumed the policy lead for trade issues at the Ministry, focusing on the TPP negotiation. He also has experience in health sector policy on eligibility criteria for publicly funded services and international relations from within a range of government agencies. His current work involves the repeal and replacement of the Medicines Act 1981 with a modern, comprehensive, and sustainable legislative framework and the implementation of TPP.
Therapeutic Products Regulations
The Government is currently developing a new domestic therapeutic products regulatory regime following the cessation of the joint ANZTPA project with Australia. As well as replacing and modernising the regulatory arrangements for medicines, the regime will cover all therapeutic products including medical devices and cell and tissue therapies, which are currently not fully regulated in New Zealand. The Government has already made a series of decisions about the new regulatory regime that were made publicly available in April 2016. Work is now focused on writing a draft Therapeutic Products Bill to replace the Medicines Act 1981 and on developing the next level of detail that will sit beneath the Bill. The presentation will explain the key elements of the regime as agreed in the documents released by Government, focusing on areas of interest such as clinical trials. It will also provide an update on progress and set out the steps in the process to develop and implement the regime.
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