Since 2015, a series of policies implemented by China's drug review and approval reform have built a good ecological environment for the development of innovative drugs in China. The development of innovative drugs in China has achieved initial results. In recent years, with the increase in the number of pre-approval inspection tasks for innovative drugs, prominent problems such as unclear responsibilities between drug registration applicants and entrusted units, imperfect quality management systems and many GMP observations were found in the pre-approval inspections according to the verification standards such as the "pre-approval inspection procedures" and the "main points and judgment principles on pre-approval inspection". This paper studied the characteristics of the innovative chemical drugs, sorted out the basic situation of the innovative chemical drugs, summarized and analyzed the main problems found in the pre-approval inspection of innovative chemical drugs from 2019 to 2021, and put forward corresponding suggestions, in order to provide reference for the research and development and registration of new drugs in the industry and provide reference for pre-approval inspection of innovative drugs.