Ethnic Factors in the Acceptability of Foreign Clinical Data

In the 1980s, Japan, the European Union, and the United States enacted separate regulations to increase the acceptability of foreign data in support of pharmaceutical drug approval. In the 1990s, the International Conference on Harmonization (ICH) began work on harmonizing these regulations through the E5 Expert Working Group. This paper discusses the concept and purpose of the ICH, ethnic factors which influence mutual acceptance of foreign clinical data, and the final harmonized document. This document is based on two concepts: the complete clinical data package and bridging studies. Its role in future global drug development strategies is discussed.