New Zealand

George Clinical In New Zealand

New Zealand requires only one ethics committee review per study – reducing clinical trial start-up timelines.

New Zealand has a respected reputation in medical research and is a place of innovation, honesty and entrepreneurial advancement. New Zealand offers a world class track record in early phase trials, proof of concept trials and independent, clean and precise clinical data.

New Zealand was the first country in the world to establish an electronic Population Health Index, a system that features a large database that contains approximately 20 years of health encounters and is now accompanied by an equally comprehensive Health Practitioner Index.

Sponsors who wish to conduct clinical trials in New Zealand simply make an application to Medsafe and Health and Disability Ethics Committees (HDECs), seeking permission to conduct a clinical trial in New Zealand and adhere to ongoing regulatory reporting procedures. Only one ethics committee review is required per study, which covers all sites. The process is simple and approximately takes 4-6 weeks from submission to full approval. Furthermore, Medsafe’s Standing Committee On Therapeutic Trials (SCOTT) approval process takes a maximum of 45 days (typically less). This process is not required for medical devices or new indications of New Zealand registered formulations; however, it is necessary for non-registered drug formulations.

New Zealand’s one ethical committee approval process does not require US FDA IDE filing prior to a study. As a result, sponsor’s wishing to develop medical devices for a rapid, cost-effective means and gaining early proof of concept, should consider conducting their initial clinical trials in New Zealand.

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