Main responsibilities

(1) Be responsible for the acceptance and technical review of applications for drug clinical trials and drug marketing authorization.

(2) Be responsible for the technical review on the consistency evaluation on the quality and efficacy of generic drugs. 

(3) Undertake the technical review of drugs involved in emerging medical products such as regenerative medicine and tissue engineering.

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

(5) Coordinate the inspection, testing and other work related to drug review.

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

(7) Organize relevant consulting services and academic exchange, and carry out international (regional) exchange and cooperation related to drug review.

(8) Undertake the technical work related to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) assigned by NMPA.

(9) Undertake other tasks assigned by NMPA.