cell cell
Sheila Swan
Strategy and Policy, Ministry of Health, Wellington, NZ
Sheila Swan is a Principal Policy Analyst with the Ministry of Health. She has a background in regulatory and procurement policy for therapeutic products in New Zealand. This has included management of the Ministry's therapeutics policy team, development of the NZ Medicines Strategy, and the design of governance arrangements for ANZTPA. Sheila also has experience in health sector design and in the provision of advice to successive governments on therapeutics policy from within central agencies. Her current work involves the repeal and replacement of the Medicines Act 1981 with a modern, comprehensive, and sustainable legislative framework.



Proposed New Zealand Therapeutic Legislation

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 its decisions to date about the new regulatory regime 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, provide an update on progress and set out the steps in the process to develop the regime.