Manufacturing in Australia
Rivaling other prime locations worldwide, Australia has come into its own as an international front runner for biopharmaceutical research and development. The primary advantages to manufacturing in Australia are as follows:
Ease of Clinical Trials
While continuing to provide thorough oversight of drug development, Australia’s Therapeutic Goods Administration (TGA) offers a considerably more efficient regulatory pathway through early clinical trials. Rather than requiring an Investigational new Drug (IND) filing and intensive FDA review prior to Phase I trials, the TGA operates under the Clinical Trial Notification (CTN) system, which expedites many of the lengthy and costly regulatory steps of drug development. It can be expected that patient testing for a Phase I study may begin in as quickly as four weeks, and the entire Phase I trial timeline may be accelerated by as much as six to nine months as compared to a similar trial program based in the U.S.
Manufacturing in Australia presents numerous financial incentives to biotech companies large and small. The streamlined approach in government regulation allows companies to save significantly on clinical trial related costs. In addition, the Australian government offers considerable tax benefits for companies conducting research and development domestically. Depending on its size, your company may be eligible for up to a 43.5% tax credit on R&D expenditure including clinical trials, analytics and study drug manufacture.
Top Ranked Biomedical Sector
Tremendous growth in the biopharmaceutical industry worldwide has produced a healthy and competitive environment for biotech in Australia. Shortened clinical timelines and extensive government funding have brought Australia’s biomedical sector to the forefront of the global biotech marketplace. Australia’s biomedical sector is ranked #1 in the Asia-Pacific region, and consistently ranks among the top 5 globally.