Recently, the Chinese government issued guidelines for Phase 1 clinical drug trials in an effort to make them safer, better organized and less time-consuming. International companies should identify and address the vital differences between the new Chinese regulatory framework and oversight systems in other countries and regions where they may conduct clinical trials.

With increasing investment in research and development by foreign companies in China, assuring the reliability and efficiency of the drug and device development process is a critical priority. However, this investment comes at a time of increasing concern over the efficiency and integrity of the clinical trial process in China and of complaints that the clinical trial stage of biomedical innovation has become a bottleneck for the licensing of new drugs and devices in China.