[What has been done for international harmonization and what remains to be solved?]

With the idea of expediting drug development and increasing the availability of new medicines to patients, the International Conference on Harmonization (ICH) was organized more than five years ago. Since then, significant progress has been made toward harmonizing preclinical and clinical requirements for the development of medicinal products. For companies whose drug development strategy is global and ongoing in different countries, international harmonization has been an important subject for R&D strategy as well as a critical target that must be achieved. Rhône-Poulenc Rorer, a multi national pharmaceutical company, has globally developed an anti cancer drug, docetaxel, in midstream of international harmonization efforts, and faced various difficulties related to international harmonization. In this paper, based on the author's preclinical experience obtained from the development of docetaxel, various approaches in addressing ICH related difficulties/problems and pending issues are described. In conclusion, the author acknowledges that ICH has made a significant achievement in harmonizing the requirements in certain areas of drug development. However, it seems that even a joint effort of ICH participants, pharmaceutical industry and regulatory agencies may not be enough to address social difficulties associated with drug development rather than scientific discipline. Among many other classes of drugs, the relationship with society appears to be most complicated in anti-cancer drug development, specifically at the clinical level, in which cancer patients are recruited for Phase I study. Finally, as a future target of ICH, harmonization efforts on the way NDA dossiers are appraised and processed across tri-partite regulatory authorities is of great interest for international pharmaceutical enterprises.