The Role of the Asia-Pacific Region in Global Drug Development Strategy

摘要

One of the major challenges facing the pharmaceutical industry is low research and development (R&D) productivity. Despite significant increases in R&D investment, R&D output, in terms of number of new molecular entities (NMEs) approved by regulatory agencies, has been declining. In 2007, the US Food and Drug Administration (FDA) approved only 18 truly new medicines-16 drug NMEs and 2 biologic NMEs (1). The need to reduce costs and shorten drug development timelines has led to the restructuring of R&D activities in the pharmaceutical industry. Reducing development time will not only allow earlier access to new pharmaceutical products by patients, it will also reduce development costs. Dimasi showed that a 50% reduction in development time will result in a 29% reduction in development costs (2).