Collaboration Between Japan and Other Asian Countries in New Drug Development:Japanese Industry Perspective

摘要

The global scheme of new drug development has drastically changed in the last 10 years. Due to the increased number of patients required for New Drug Application (NDA) submission and the increased cost of clinical development, many studies are conducted nowadays on a multinational basis. The arena of clinical studies has expanded into regions outside of the International Conference on Harmonization (ICH) such as Asia, Central and South America, eastern Europe, and other regions, with the introduction of the ICH-Good Clinical Practice (GCP) guideline being the trigger of this trend.