Opportunities and Challenges for Global New Drug Submission and Clinical Development after China's Accession to ICH

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.