The marketing or imitation of overseas marketed drugs is an important means to solve the availability and accessibility of drugs in urgent clinical needs of patients in China. In order to speed up the research & development and marketing processes of such drugs, strengthen the scientific regulation, according to the Provisions for Drug Registration (SAMR Order No.27) and supporting documents thereof, upon the approval by NMPA, CDE issued theClinical Technical Requirements for Drugs Marketed Overseas but Not Marketed in China on October 9, 2020, which shall come into force as of the date of issuance.