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February 21, 2020updated 13 Mar 2020 7:00am

Regulatory requirements for clinical trials: A comparison of Australia and the US

The regulatory environment in Australia and New Zealand offers a significant strategic opportunity for international biotech companies wanting a fast and pragmatic regulatory pathway for early phase clinical trials.

The regulatory environment in Australia and New Zealand offers a significant strategic opportunity for international biotech companies wanting a fast and pragmatic regulatory pathway for early phase clinical trials.

With streamlined regulatory requirements and the supportive R&D Government refund of up to 41% on clinical research spend, Australia has become a preferred destination for early phase clinical trials.

Importantly Australia and New Zealand also offer alternative recruitment potential to northern hemisphere seasonal related studies.

The number of clinical trials has grown solidly in the last few years in Australia, enjoying a steading +10% growth on average between 2016 and 2018.

While the simplified regulatory framework and cash refund scheme has brought many biotechnology companies to Australia for their first-in-human trials, the phase mix remains balanced over that period with a significant portion of late phase trials also.

The Therapeutics Good Administration (TGA) is the regulatory body in Australia. To conduct a clinical trial in Australia, the trial must have an Australian sponsor. There are two main options for submission of clinical trial proposals, the Clinical Trial Notification (CTN) or the Clinical Trial Exemption (CTX). An IND submission is not necessary to initiate first-in-human clinical trials in Australia.

The simplicity and efficiency of the Australian and New Zealand regulatory and ethics processes often means biotechnology companies can commence a clinical trial in parallel to the preparation of an US IND submission, often commencing dosing within a single review cycle of six to eight weeks from submission.

Timeline estimates for a first-in-human completion in Australia compared with Europe and North America

Clinical trial application requirements in Australia, US and EU

About Novotech

Novotech provides regulatory and clinical consulting services to biotechnology companies through its specialized division CNS BioDesk.

BioDesk offers its clients one of the most experienced and cohesive regulatory, CMC and toxicology expert groups available across three continents.

To learn more or talk to their experts about your clinical trial, visit novotech-cro.com/medical-services

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