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February 21, 2020updated 13 Mar 2020 8:53am

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.

Free Whitepaper
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Evolution of clinical trials in the Asia Pacific region compared to the US and the EU5

Over the last five years, the global clinical trial landscape has been transformed. Between 2017 and 2020, 70,000 new clinical trials were registered across the APAC region, the US and the EU5. The APAC region contributed more than 50% of these trials and saw the most growth. APAC, especially China, is emerging as the hot spot for conducting clinical trials. This whitepaper takes a deep dive into why China has been attracting more foreign biopharma companies in recent years. It presents an in-depth analysis of the evolution of clinical trials in the APAC region compared to the US and EU5.
by Novotech
Enter your details here to receive your free Whitepaper.

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

Free Whitepaper
img

Evolution of clinical trials in the Asia Pacific region compared to the US and the EU5

Over the last five years, the global clinical trial landscape has been transformed. Between 2017 and 2020, 70,000 new clinical trials were registered across the APAC region, the US and the EU5. The APAC region contributed more than 50% of these trials and saw the most growth. APAC, especially China, is emerging as the hot spot for conducting clinical trials. This whitepaper takes a deep dive into why China has been attracting more foreign biopharma companies in recent years. It presents an in-depth analysis of the evolution of clinical trials in the APAC region compared to the US and EU5.
by Novotech
Enter your details here to receive your free Whitepaper.

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