On the Amendments of China's Provisions for Drug Registration

Abstract

China's recently amended and released Provisions for Drug Registration differ from the previous ones in that they have greater emphasis on creating a high standard for drug safety by improving supervision of the registration process and upgrading drug evaluation and approval standards to encourage innovation. Specifically, the new regulation (1) redefines the concept of “new drugs”; (2) specifies the drug categories deserving special approval process; (3) simplifies the contents for preclinical and clinical trial requirements; (4) introduces the term generic drugs; (5) imposes stricter requirements for drug reregistration, supplementary registration, and approval for manufacturing processes and drug package inserts; (6) articulates specific circumstances under which a drug registration application can be denied; (7) adjusts the timelines for the evaluation and approval process; and (8) details legal responsibilities for regulatory personnel and drug registration applicants. The article provides some insights on the amendments of the new Provisions for Drug Registration in China.