Main responsibilities

(1) Assist the Center for Drug Evaluation of NMPA in pre- and in-process communication and guidance, as well as relevant inspections for drug review in the Yangtze River Delta (YRD) region.

(2) Assist in the acceptance and review of registration application of drugs in the YRD region under the administration of the Center for Drug Evaluation of NMPA.

(3) Assist in relevant inspections for drug registration application and for-cause inspections during the research and development process in the YRD region under the administration of the Center for Food and Drug Inspection of NMPA (National Center for Vaccine Inspection).

(4) Participate in the drafting of laws, regulations and normative documents related to the registration administration of drugs; participate in the formulation of relevant technical review norms, technical guidelines, inspection system specifications and technical documents for drugs and organize the implementation.

(5) Carry out research on the theories, technologies, development trends, policies and legal issues related to drug review and inspection.

(6) Carry out relevant consulting services, academic exchanges, and international (regional) exchanges and cooperation related to drug review and inspection.

(7) Undertake other tasks assigned by NMPA, and other technical work assigned by the Center for Drug Evaluation of NMPA, and the Center for Food and Drug Inspection of NMPA (National Center for Vaccine Inspection).