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Bio Technology : October 2009
26 Australasian BioTechnology Volume 19 • Number 3 • October 2009 AusBioFEATURE --- AusBiotech 2009 By Peter Embley, Associate Director, Regulatory Affairs, Kendle Clinical drug development in Asia-Pacific Asia Pacifc (AP) is a region of high economic growth with large foreign currency reserves. IMS Health reported that the market is currently the fastest growing region globally. AP comprises a large population embracing a westernised lifestyle and disease patterns. The region is conducive for fast recruitment of patients for clinical trials resulting in a shortened drug development time and cost effciencies to the company. Inspection agencies such as the US Food and Drug Administration (FDA) have reported the quality standards for many operations in the region as comparable to North America and Europe. Despite the incentives, the regulatory assessment procedures still present problems due to the lack of a common clinical trial application (CTA) procedure and frequent legislative changes at a national level. Success in the region could be achieved by forming a strategic alliance with a partner who has regional expertise. This article looks at the clinical development potential and regulatory drivers in some of the key markets. It also outlines some of the challenges in the key markets and how one could become successful in overcoming those challenges. The shift in clinical development from North America and Europe to other regions of the world is now a clear and sustained trend. The growth of the pharmaceutical market in AP is largely due to the increase in gross domestic product (GDP), which is a good indicator for prosperity and a growing consumer market. Recent economic growth in China and India indicate a growing consumer market and GlaxoSmithKline, among others have announced plans to reorganise their global operations to better serve these markets. The principle reasons for the changes are detailed below: Clinical development potential The International Conference on Harmonisation's (ICH) guidance on good clinical practice (GCP) has been widely accepted within the region and provides a common standard to ensure the necessary quality for conducting clinical trials for global markets. With two of the world's most populated countries in