Updated on 5 September 2013
Australia has provided international stakeholders with a safe, professional and cost-effective stepping stone in to the Asian growth markets.
International standards of conduct for clinical trials, developed by the International Conference on Harmonisation (ICH) and the International Organization for Standardization (ISO), provide a benchmark of clinical research quality. Also, the ICH or ISO good clinical practice (GCP) standards are mandatory for all Australian clinical trials, which involve unapproved medicines or medical devices. The regulations in the country currently revolve around a simple Clinical Trial Notification (CTN) scheme administered by the Therapeutic Goods Administration (TGA), which has helped in obtaining approvals within weeks. Under this scheme, research proposals are submitted directly to the Australian Human Research Ethics Committees (HRECs).
The committee assumes primary review responsibility for ethical and scientific review. The TGA also administers the Clinical Trials Exemption (CTX) scheme, under which proposals are submitted to the TGA for scientific review followed by ethical review conducted by the HREC.
Australia has also developed ethics review processes for multi-center research in order to help reduce unnecessary duplication of review of research. Furthermore, the tax credit scheme has attracted many, as it allows eligible applicants to receive a 45 percent reimbursement of research and development expenditure. Well-defined regulations, swift and efficient procedures, advanced infrastructure, cost efficiency, and strategic geographical location have all added to Australia's popularity as a research hub. The country has close trading ties with many Asian countries and is in close proximity of the expanding South East Asian markets too. Further, the fact that the Northern and Southern hemisphere seasons are reversed also provides an advantage when conducting trials here.
The paradigm is now shifting towards conduction of priority-driven research and the system is aiming towards capacity building to create an economically sustainable healthcare system. Australia's agenda for the coming years is to improve the research integrity by establishing an independent regulator and create a reward system for early and public self-disclosure of errors. The system will also aim at creating a punishment for intentional or reckless misconduct after active independent investigation of allegations.