In recent decades, the Chinese pharmaceutical industry has developed at an accelerating pace, and the drug registration and approval system in China has undergone a series of dramatic changes and reforms. As current provisions became incompatible with sector development, the China Food and Drug Administration (CFDA), the supreme drug regulatory authority in China, has updated the current regulation system of drug registration and approval. This article describes the current state of regulation, comprehensively discloses the proposed new rules, and concludes with the potential implications for the future.