SY09-2 Promoting collaboration between PMDA and regulatory agencies in Asia

Abstract

Asian countries are remarkably modernizing in a few decades. In the area of pharmaceutical products development, we firstly consider how to collaborate with US and/or US decades ago, but recently it is shifting to how to collaborate with Asian countries. But most of Asian countries do not have so much experiences in conducting review for regulatory approval in own countries, because these countries allow distribution of pharmaceutical products with CPP of developed countries. Furthermore, it must be said the that the experience of assessing clinical trial protocols is so limited.