The regulatory environment in Australia offers a significant strategic opportunity for domestic and international companies to take advantage of a uniquely fast and pragmatic regulatory pathway for clinical trials. Coupled with the Australian Research & Development (R&D) Tax Incentive Program – the most attractive currently available internationally (offering a 45 per cent refundable tax offset for R&D spend in Australia to those eligible) Australia is highly attractive as an option for those planning to conduct clinical trials.
According to the World Health Organisation, a “clinical trial is any research project that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes”.
Clinical trials are used to test new forms of therapy and evaluate potential treatments that have had some positive effect against disease. They may test new treatments, including new drugs, surgical procedures, medical devices (such as pacemakers or stents), or novel approaches to treatment, such as gene therapy. Clinical trials can also look at other aspects of care, such as improving the quality of life for people living with chronic illnesses.
- are necessary to advance medical science and make new therapies available to both doctors and patients
- are essential to ensure innovation in medical treatment and optimal standards of medical practice for all Australians
- improve the diagnosis and treatment of disease for patients and
- provide access to the best and most appropriate cures and therapies available worldwide.
Through the coordination efforts of LSQ and QCTN, Queensland has developed an international reputation for its clinical trial expertise including pre-clinical and early clinical phase development work, pharmacokinetics and pharmacogenomics. State-of-the-art medical research facilities and hospitals, an environment that stimulates clinical trial professionalism and co-operation and adherence to national and international ethical, quality and regulatory standards, make Queensland a prime choice for national and international sponsors wishing to conduct clinical trials.
Australian Regulatory System Overview
The Australian community expects that medicines and medical devices in the marketplace work well, are safe and of high quality, and at least equal to the standard of goods available in comparable countries. The objective of the Therapeutic Goods Act 1989 (The Act) is to provide a national framework for the regulation of therapeutic goods in Australia to ensure the quality, safety and efficacy of medicines and the quality, safety and performance of medical devices.
The Act takes a risk management approach to ensure public health and safety, while at the same time freeing industry from any unnecessary regulatory burden. It requires that medicines and medical products to be imported into, supplied in, or exported from Australia be entered on the Australian Register of Therapeutic Goods (ARTG). The ARTG is a database of information about therapeutic goods for human use – their contents and classification details – which are approved for supply in, or exportation from, Australia.
Periodically, the TGA reviews regulatory guidelines issued by the European Union (EU) and issues statements on whether a specific EU guideline has been adopted. In the case of particularly innovative, controversial or evolving regulatory matters, the TGA tends to take a best practice approach. This process involves considering existing overseas guidelines, particularly those issued by the EU and the International Conference on Harmonisation (ICH), as well as the U.S. Food and Drug Administration (FDA), in the context of the local Australian industry, healthcare and social factors.