In order to further guide enterprises to carry out drug R&D, accelerate the R&D and marketing process of chemical drugs that have been marketed overseas but not in China, and provide technical standards that can be used as references, the CDE, under the guidance of NMPA, has organized to formulate the Technical Requirements for CMC Study and Evaluation of Chemical Drugs Marketed Overseas But Not Marketed in China (Interim), which was issued and implemented as of March 3.