Main responsibilities

(1) Organize the formulation and revision of the normative and technical documents for the inspection of drugs, medical devices and cosmetics.

(2) Undertake the certification inspection and relevant supervision and inspection of the Good Laboratory Practice for non-clinical laboratory studies (GLP), and the supervision and inspection of drug clinical trial institutions. Undertake the pre-approval inspection of drugs and for-cause inspection throughout the drug development and manufacturing process. Undertake overseas inspection of drugs. 

(3) Undertake the for-cause inspection in the vaccine development and manufacturing process and the inspection of vaccines and blood products manufacturing. Undertake overseas inspection of vaccines.

(4) Undertake the supervision and unannounced inspection of clinical trials of medical devices and for-cause inspection in the development and manufacturing process of medical devices. Undertake overseas inspection of medical devices.

(5) Undertake the pre-approval inspection and related for-cause inspection of the registration of special cosmetics and the registration and filing of new raw materials for cosmetics, as well as the for-cause inspection in the manufacturing process. Undertake overseas inspection of cosmetics and new raw materials for cosmetics.

(6) Undertake the management of national-level professional and specialized inspectors of drugs, medical devices, and cosmetics. Guide the management of such inspectors at the provincial level.

(7) Guide the establishment of quality management systems of drug inspection institutions in provinces, autonomous regions and municipalities directly under the central government, and conduct related assessments.

(8) Conduct research, academic exchanges and technical consultation on inspection theories, techniques and development trends, and carry out training for national-level inspectors.

(9) Undertake international (regional) exchanges and cooperation in the inspection of drugs, medical devices and cosmetics.

(10) Undertake food inspection entrusted by the State Administration for Market Regulation.

(11) Undertake other tasks assigned by the NMPA.