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

Abstract

Asia-Pacific is a region of high economic growth with large foreign currency reserves. IMS Health reported that the Asian pharmaceutical market was the fastest growing region in 2007, with more than double the global growth rate. From a commercial perspective, it is a region that will drive growth in the future. From a drug development perspective, the large population with an increasingly Westernized lifestyle and disease patterns, together with a large pool of health care professionals and a favorable competitive environment, will allow fast recruitment of patients, resulting in shortened drug development time and allowing early access to innovation by patients as well as cost savings to the pharmaceutical industry. The lack of clinical trial experience is compensated for by the return of highly skilled Asians from overseas. Many governments have made significant investment in both infrastructure and training to ensure quality National GCP, based on ICH GCP, has been launched in all major countries within the region, and GCP is law in many countries. Results of FDA clinical inspections published on its website showed quality similar to North America and Western Europe. Regulatory agencies have made significant improvements in terms of efficiency and the timeline for clinical trial approvals is now competitive on a global basis in most countries. The formation of FERCAP in 2000 and its training and recognition programs have made significant contributions to quality improvement in institutional ethics committees. In conclusion, the Asia-Pacific region is worthy of a key role in drug development strategies in terms of commercial return as well as improving cycle time leading to early access to innovative products on a global basis.