The purpose of the ICH guideline on ﾒEthnic Factors in the Acceptability of Foreign Clinical Dataﾓ is to provide regulatory and development strategies that will permit adequate evaluation of the influence of ethnic factors while minimizing duplication of clinical studies and supplying new medications expeditiously to patients for their benefit. Then, the number and size of clinical studies in a new region should be minimized by bridging strategies, on the basis of adoption of similar disease criteria among different regions and proper processes of clinical evaluation. Furthermore, if new drugs shown an excellent efficacy and good tolerability in foreign clinical studies, the duplication of clinical studies in a new region is not essential and it may even be considered unethical for patients to be enrolled in such studies. Since clinical trials performed in the USA often assess ethnic factors, a pharmacokinetic study and careful post-marketing surveillance are sometimes enough for approval in a new region.

Recently, new anti-rheumatic agents, such as a new class of non-steroidal anti-inflammatory drugs, selective cyclooxygenase-2 inhibitors, and biologic agents targeting pro-inflammatory cytokines, have been approved by the FDA in the USA and some other countries. Some of them are now under clinical development using bridging strategies in Japan. In this symposium, the differences between clinical studies performed in the USA and Japan will be introduced using data on already approved anti-rheumatic agents and some drugs under development from the point of view of a Japanese rheumatologist. The concept of ideal bridging studies for global strategies will also be discussed.