ABSTRACT
In the recent years, with the decoding of human genome and the advance of pharmacogenomics, issues on ethnic and population differences have become the focus in the new drug approval process, especially in Asia. Since most of the new medicines were developed in Western countries, the ef‚- cacy and safety were generally established based on Caucasian majority. It would be a major concern in the drug regulation process whether the foreign clinical data could be naively extrapolated to the population of Asian region. In 1998, a consensus had been reached as summarized in the ICH E5. The guidelines addressed both the intrinsic and extrinsic factors that are associated with characteristics, culture, and environment of a drug. They also provided a framework for investigating 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 sacri‚cing the quality, safety, and ef‚cacy.
