Navigating The Complexities Of An IND Submission In The Emerging Chinese Market

While China’s pharmaceutical market is growing at a steady pace, the drug registration timeline and process has been notoriously complex and lengthy, leading to a severe backlog of investigational new drug (IND) application submissions and an average delay as long as 14 months to register a clinical trial for an innovative drug.¹ These challenges, combined with a focus on driving new drug innovation in China, led to efforts in 2015 to amend and reform the review and approval system for drugs and medical devices in China as well as improve drug quality.²