It has been recognized that globalization of drug development is essential, since pharmaceutical companies, physicians and researchers are currently urged to speed needed medicines to patients over the world, and ICH has made a big contribution for the globalization of drug development .

On August 7, 2000, 43 guidelines in total have reached either Step 4 or Step 5. In Quality Section, the most important guidelines include "Impurities in new drug substances (Q3A)" and "Test procedures and acceptance criteria for new drug substances and new drug product (Q6A) and those for biotechnological/biological products (Q6B)". In Safety Section, most helpful guidelines are "Guideline on reproductive toxicology for medicinal products (S5A/B)", "Preclinical safety evaluation of biotechnology-derived pharmaceuticals (S6)" and "Nonclinical safety studies for the conduct of human clinical trials for pharmaceuticals (M3)". In Efficacy Section, the most influential guidelines in Japan are "Guideline for ethnic factors in the acceptability of foreign clinical data (E5)" and "Guideline for GCP(E6)". Details of these important guidelines and their impact will be discussed.

ICH guidelines have been contributing to improvement of scientific and ethical levels of tests and to reduction of repetition of tests. ICH process for guidelines has also promoted mutual communication among reguratory authorities, scientists and pharmaceutical field in ICH three regions. In Japan, through ICH process more data of foreign clinical studies will be accepted as a part of clinical data package, thus facilitating new drug development.