Abstract: This paper focuses on the new era of drug registration management system constructed by the Provisions for Drug Registration, focuses on the registration and inspection work of overseas production of chemical drugs, and analyzes its main changes as well as the opportunities and challenges brought about. In order to deepen the knowledge and understanding of applicants and testing organizations on the registration and inspection work, improve the quality of registration and inspection work, improve the efficiency of registration and inspection work, and accelerate the listing of overseas new drugs to provide a reference, so that more new drugs and good drugs approved and listed to the benefit of the people.