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

Abstract

The arena of global clinical trials is expanding into non-ICH regions. Many Asian countries, outside of Japan, have accumulated experience in multinational clinical studies. On the other hand, after achieving high-quality clinical trial mechanisms, Japan is willing to participate more in multinational studies. There are good opportunities for collaboration between Japan and other Asian countries. Sometimes, a study accommodating specific needs of the Asian region is more justified than a global study. The Asian region can contribute more on the scientific side, by participating in the earlier phases of drug development. Complementary collaboration is possible with Japan providing know-how in early drug evaluation and other Asian countries providing experience in multinational clinical studies. Asian regulatory networks and activities of the ICH Global Cooperation Group are also expected to enhance such an environment.