1. Executive Summary

This guidebook provides an overview of the current regulatory landscape in New Zealand in relation to Decentralized Clinical Trials (“DCT”). New Zealand abides by the regulations set forth by the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) and the Health Research Council of New Zealand (HRC). The regulations in New Zealand are largely based on those of Australia and the European Union. 

There is no evidence to confirm that a fully decentralized trial has not been conducted in New Zealand. However, elements of decentralization have been incorporated into local studies over the last 5 years and there is a general increase in acceptance of decentralized trials following the COVID-19 pandemic and because of the geographic dispersity of New Zealand. In August 2023, the New Zealand Association of Clinical Research issued SOPs governing the aspects of Decentralized Trials.