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It is well known fact that the technology used to support medicines, particularly those derived from biotechnology Bruce Irvin Raiders Jersey , is complicated. A lesser known fact however was more widely proclaimed in 2012, by Mark Metherell, health correspondent of the Sydney Morning Herald. On a per capita basis Kelechi Osemele Raiders Jersey , the overall value of Australia’s publically traded biomedical companies was higher than for companies in the United States. Chairman of pharmaceutical industry association Medicines Australia, Mark Masterson, has revealed an ambitious agenda as a result of such promising value-added developments. “The vision is to double our manufacturing output from AUD7 billion (USD7.34 billion) in 2012 to AUD14 billion (USD14.68 billion) over the next decade and to establish a number of highly specialised bio-manufacturing plants Marshawn Lynch Raiders Jersey ,” Masterson said in December 2012. “Double our exports from AUD4 billion (USD4.19 billion) to AUD8 billion (USD8.39 billion); double our R&D investment from AUD1 billion (USD1.05 billion) to AUD2 billion (USD2.1 billion); creating many more high-skilled jobs and increasing the number of Australians accessing clinical trials to 30,000.”

There are many other reasons to manufacture biologics in Australia. Another is that the large number of mutual recognition arrangements that exist with Australia and key international regulatory authorities. For example, the US Food and Drug Administration (FDA) has signed a Memorandum of Understanding (MOU) with the Australian Therapeutics Goods Administration (TGA) which allows the two organizations to exchange information on Good Manufacturing Practice (GMP) inspections of pharmaceuticals facilities. This represents a streamlined approval process for Australian-based pharmaceutical companies seeking to market their products in the US.

Over the past decade Australia has developed robust clinical trial infrastructure that in general reduces the overall cost of biotherapeutic product development. This is because Australia has a favourable regulatory environment Karl Joseph Raiders Jersey , world renowned hospitals and a medical system with a strong reputation for high quality clinical development. Australia has also holds a leading international position in robotics research and in automated process control which can be leveraged to streamline bioprocessing cost within a manufacturing setting.

Australia’s robust and internationally compatible intellectual property regime is recognised as being one of the most effective and modern systems in the world in terms of patents and copyright enforcement. In fact, Australia’s intellectual property system is ranked above countries such as the UK, Japan Eddie Vanderdoes Raiders Jersey , Hong Kong and Singapore

All this is augmented by Australia’s unique R&D tax situation. The Australian Taxation Office allows up to a 45% tax deduction, which under some circumstances can be in the form of a cash refund, on eligible R&D expenditure that can include the manufacture of materials for clinical testing. This makes Australia a very attractive location not only for manufacturing and clinical trials Gareon Conley Raiders Jersey , but also as a base for establishing R&D operations.

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