The New Zealand Government has been working on a new and comprehensive regulatory regime to regulate therapeutic products in New Zealand, which will replace the Medicines Act 1981 and its Regulations. As well as replacing and modernising the regulatory arrangements for medicines, the regime will provide regulation of all therapeutic products. This includes medical devices and cell and tissue therapies which are currently not fully regulated in New Zealand. The NZ Government is seeking a high-quality regime that is efficient and sustainable, positions New Zealand well on the international stage and is designed so it can be kept up to date easily.
In 2017, work continues on the development of the detail of the therapeutic products regulatory regime consistent with the decisions released in April 2016. Consultation on the Exposure Draft of the Therapeutic Products Bill was anticipated in 2016 however, due to the scale of this project and the large amount of detail that needs to be developed, consultation will now occur in 2017.
Medsafe speakers will provide an overview of the background to the new regulatory regime, provide some insight into the legislation, and discuss the next steps towards the new regime and how stakeholders can understand the issues and participate in processes that will inform the outcome.
Chairperson: Ailsa Surman, Regulatory Affairs Senior Manager, Amgen