Implementation of Bridging Strategy in Taiwan

Recently, with the advance of human genome decoding and pharmacogenomics, issues on ethnic and population differences have taken the center stage in the new drug approval process. Since most of the new medicines were developed in western countries, the efficacy and safety of a drug was generally established based on Caucasian majority. Whether the foreign clinical data could be naively extrapolated to the population of a new region would be a major concern, especially in Asia. In March 1997, a consensus has been reached for ICH-E5 (1). The guidelines address both the intrinsic and the extrinsic factors that are associated with drug characteristics, culture and environment; and provide a framework for evaluating the impact of ethnic factors upon the medicines’ effect. The principal objective of E5 is to expedite the global development and availability of new medicines to patients without sacrificing the quality, safety and efficacy. While minimizing duplication of clinical studies, the guidelines also facilitate the use of bridging studies to allow extrapolation of foreign clinical data to a new region. Since the introduction of ICH-E5 and the bridging concepts, awareness has increased among nations about the need for local clinical trials. Many Asian countries including Japan, Korea, and Taiwan, have formally announced the implementation of the bridging study requirement. Other Asian countries are also showing great interest in setting up a well-designed bridging study system.