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Bio Technology : October 2009
Volume 19 • Number 3 • October 2009 Australasian BioTechnology 9 medical products that can benefit Asia Pacific and the West alike, while minimising the rapidly escalating costs of generating the supportive data. This might be aided through more public/private/university partnerships in each region; use of a coordinating body of expert medical product developers; establishment and linking of 'incubators' supported by local/central governments and others to allow for sharing of utilities, educational and other resources and facilities; and testing of developmental profiles for medical products through outsource providers who are intimately familiar with the regulatory needs of the biggest markets for products, such as the EU, Japan and the US. Increasing cooperation between the US FDA and the regulatory authorities in Asia and the Pacific are placing more pressure on sponsors of medical products and others involved in their development to respond in kind with planning, concentration of resources, intelligent use of funding and initiation of sophisticated systems for documenting medical product development. It is imperative to examine each concept and prototype product not just with respect to the theoretical soundness of its prospects but also in light of the practicality of the concept in the regional/global competitive environment and the realities of the regulatory arena. No matter how sound a concept, sophisticated a construct and exciting as early pre-clinical or clinical data may be, the regulatory process is what drives the final success of a product, along with the perceived patient need for the product and a sponsor's ability to economically manufacture it. Sensitivity to regional Asia Pacific needs, along with an objective approach to the realities of the global regulatory climate can help ensure success for these products.