Although the major drug development regions of the world are recognized to be North America, Europe, and Japan, continuing
growth of the pharmaceutical market in emerging regions is being accompanied by similar growth in clinical trial activity
outside the traditional "big three" markets, as reflected in recent editions of Applied Clinical Trials where feature articles have included overviews of Africa and Asia. Australia might be considered as laying somewhere in between:
Australia's market size certainly does not compare to the big three pharma superpowers; nor can it be considered as an emerging
market. Major Australian cities regularly rate highly on quality of life surveys, but it may surprise some that a recent international
benchmarking study undertaken by The Economist Intelligence Unit ( http://www.eiu.com/) identified Australia as the number one location to conduct pharmaceutical clinical trials.
The Economist Intelligence Unit study, "Benchmarking Study of the Australian and International Pharmaceuticals Industries," was commissioned
by the Australian Government Department of Industry, Tourism and Resources; Invest Australia; and the Victorian Government
Department of Innovation, Industry and Regional Development.1 It compared and benchmarked Australia against the United States, the United Kingdom, Germany, Japan, Singapore, and India
across a range of indicators including clinical trials, the intellectual property system, the regulatory environment, and
the investment and business environment. Australia ranked second overall, with Singapore ranking first. Australia scored highly
for many indicators relating to the industry skills pool, practices, and regulatory processes, but scored below Singapore
and India on costs. In relation to clinical trials, Australia ranked first overall (as a weighted aggregate), boosted by low
average costs of clinical trials, a relatively large amount of recognized trial sites, and a high percentage of clinical trials
completed within the allocated time. Of particular interest to overseas sponsors was the observation that Australia does less
well on the total amount of clinical trials taking place even on a per-capita basis, suggesting there is capacity for further
growth within the sector.
ACTBITS
|
While being identified as an attractive location for conducting clinical trials is music to the ears of the Australian pharmaceutical
and biotechnology industry—an AUD$12 billion sector employing 35,000 people, exporting almost AUD$2 billion a year,1 and the second largest contributor of manufactured goods to the Australian economy (more than its wine industry)—potential
clinical trial sponsors are perhaps more concerned with the realities. They might ask the following: Will my intellectual
property be protected? How do I obtain regulatory approval? How long will it take? How fast can I enroll patients? How do
I get my clinical trial material into Australia? Will the study be performed according to ICH GCP? Will the FDA or the EMEA
recognize the quality of the study and accept the data?
Regulatory framework in AustraliaPerhaps reflecting its historical and constitutional links with Great Britain, Australia's regulatory framework for therapeutic
goods is primarily based on that of the European Union. Periodically, the Australian Therapeutic Goods Administration (TGA)
reviews regulatory guidelines issued by the European Community (EC) and issues statements on whether a specific EC guideline
has been endorsed or not. In the case of particularly innovative, controversial or evolving regulatory matters, the TGA tends
to take a best practice approach, whereby it considers existing overseas guidelines, particularly those issued by the ICH,
EC, and FDA, in the context of the local Australian industry, health care, and social factors.
Facebook
