The State Drug Administration ("SDA") and the National Health Commission ("NHC") have recently issued the Announcement on Optimizing the Evaluation and Approval of Drug Registration (the "Announcement"), immediately effective from the issue date.
The Announcement proposes to put in place the work mechanism for prioritized evaluation and approval of drugs, adding that the Center for Drug Evaluation under the SDA will establish a mechanism for the communication with parties that apply for the registration of drugs used to prevent and cure diseases which seriously endanger life and cannot be effectively cured by existing therapies, and drugs for rare diseases, provide better guidance to the research and development of drugs, and allocate resources first to evaluate, check, examine and approve applications filed for registering those drugs subject to prioritized evaluation and approval, in a bid to expedite the evaluation and approval process. Additionally, the Announcement explicitly states that, where a type of drug used to prevent and cure a disease which seriously endangers life and cannot be effectively cured by existing therapies or drug for a rare disease, has been launched on the overseas market, the party intending to apply for registering this type of imported drug may directly file an application for registering this type of drug for the marketing purpose by submitting data obtained from overseas clinical trials, provided that this applicant establishes after studies that the curative effect of this type of drug will not be affected by the distinction between different races. Furthermore, the Announcement provides that the procedures for checking archives for the re-registration of imported drugs will be abolished, adding that after an application filed for re-registering imported drugs is accepted, all materials will be transferred to and evaluated by the Center for Drug Evaluation.