Abstract: In 2017, China joined the the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), which is the most influential non-governmental organization in the pharmaceutical field. This will bring great opportunities & challenges to China's pharmaceutical industry. From regulatory perspective, this article compares the market authorization, clinical trial application, consultation and communication between China & the ICH members such as the U.S., EU and Japan. Besides, it summarizes the gaps between China and these countries/area in clinical development environments, including clinical start-up, clinical trial environments and innovative clinical trials, with some good experience of reference for the China's pharmaceutical companies.