Organizational Structure of CFDI for National Medical Product Administration (NMPA)
(I) Office
Take charge of administrative affairs and comprehensive coordination of CFDI. Formulate management system and development plan and organize the implementation of them. Undertake meetings, official documents, seal and archive management, government affairs information, news and promotion, inspection and supervision, security and confidentiality, emergency management, petition handling and visit reception, and logistics support. Organize drafting of comprehensive documents. Undertake other tasks assigned by CFDI.
(II) Division of Inspection Coordination & Quality Management
Take charge of comprehensive management of the inspection business of CFDI and daily management of the quality management system. Take the lead in the selection and appointment, education and training, assessment and evaluation, dispatching and allocation, performance supervision, and other management of national inspectors, and guide the management of provincial inspectors. Guide the construction of quality management systems of drug inspection institutions in all provinces, autonomous regions, and municipalities directly under the Central Government, and conduct assessment. Organize and conduct research on inspection theory, foreign cooperation, academic exchanges, and technical consulting services. Take charge of daily management of the Academic Committee and Expert Advisory Board of CFDI. Lead to inspect the international (regional) exchanges and cooperation. Undertake other tasks assigned by CFDI.
(III) Information Management Division
Take charge of construction and management of information system, database and website. Undertake the construction of the inspector information platform. Organize and carry out classified protection of information security. Undertake other tasks assigned by CFDI.
(IV) Inspection Division I
Organize the formulation and revision of inspection systems, specifications, and technical documents related to clinical trials of drugs and medical devices. Organize and conduct the supervision and inspection of drug clinical trial institutions. Organize and conduct the registration verification and for-cause inspection of clinical trials of drugs. Organize the supervision, random inspection and for-cause inspection of clinical trials of medical devices. Conduct overseas inspection, international (regional) exchanges and cooperation, and relevant technical research in related fields. Undertake daily maintenance and management of the filing system for clinical trial institutions of drugs and medical devices. Undertake the management of national inspectors in relevant fields. Undertake other tasks assigned by CFDI.
(V) Inspection Division II
Organize formulation and revision of the rules and technical documents on the relevant inspection of drug non-clinical research. Organize and conduct pharmacological and toxicological research related to drug registration as well as on-site verification and for-cause inspection of bioequivalence tests. Organize and conduct certification inspection and relevant supervision and inspection of Good Laboratory Practice. Conduct overseas inspection, international (regional) exchanges and cooperation, and relevant technical research in related fields. Undertake daily maintenance and management of the information platform for drug non-clinical safety evaluation and research institutions. Undertake the management of national inspectors in relevant fields. Undertake other tasks assigned by CFDI.
(VI) Inspection Division III
Organize formulation and revision of the rules and technical documents on the inspection of biological products. Organize and conduct pharmaceutical development and on-site production verification related to the registration of biological products. Undertake the for-cause inspection of pharmaceutical development and production processes of biological products. Undertake the production inspection of vaccines and blood products. Organize relevant Adverse Events Following Immunization (AEFI) inspection. Conduct overseas inspection, international (regional) exchanges and cooperation, and relevant technical research in related fields. Undertake the management of national inspectors in relevant fields. Undertake other tasks assigned by CFDI.
(VII) Inspection Division IV
Organize formulation and revision of the rules and technical documents on the inspection of chemical drugs and traditional Chinese medicines. Organize and conduct pharmaceutical development and on-site production verification related to the registration of chemical drugs and traditional Chinese medicines. Undertake the for-cause inspection of pharmaceutical development and production processes of chemical drugs and traditional Chinese medicines. Conduct overseas inspection, international (regional) exchanges and cooperation, and relevant technical research in related fields. Undertake the management of national inspectors in relevant fields. Undertake other tasks assigned by CFDI.
(VIII) Inspection Division V
Organize formulation and revision of the rules and technical documents on the inspection of medical devices. Organize and conduct the supervision and random inspection of products for clinical trials of medical devices, and the for-cause inspection in the development and production processes. Conduct overseas inspection, international (regional) exchanges and cooperation, and relevant technical research in related fields. Undertake the management of national inspectors in relevant fields. Undertake other tasks assigned by CFDI.
(IX) Inspection Division VI
Organize formulation and revision of the rules and technical documents on the inspection of cosmetics. Organize and conduct the registration of special cosmetics, filing verification and for-cause inspection of new raw materials for cosmetics, and related for-cause inspection of the production process. Conduct overseas inspection, international (regional) exchanges and cooperation, and relevant technical research in related fields. Undertake the management of national inspectors in relevant fields. Guide the implementation of the technical work of Good Supply Practice (GSP) of Drugs and Medical Devices. Undertake relevant food inspections entrusted by the State Administration for Market Regulation. Undertake other tasks assigned by CFDI.
(X) Human Resources Division (Party Committee Office)
Take charge of daily work and personnel management of the Party Committee and the Commission for Discipline Inspection of CFDI. Undertake cadre personnel, organization establishment, salaries and insurance, education and training and cadre supervision of CFDI. Formulate and organize implementation of work plans and systems of party construction and discipline inspection. Take charge of the specific work related to the full implementation of the subject responsibility of enforcing strict Party discipline and building a clean government. Undertake Party organization construction, construction of the Party conduct and of an honest and clean government, discipline inspection and daily education management of party members and leading cadres, and supervision, enforcement of discipline and accountability of CFDI. Undertake management and consolidation of labor unions, the Communist Youth League, women's committees and other alliances. Undertake management and service of retirees. Undertake other tasks assigned by CFDI.
(XI) Finance Division
Take charge of financial management of CFDI. Take charge of budgeting, final accounting and budget execution monitoring. Take charge of funds management, daily financial management, as well as accounting and supervision of state-owned assets of CFDI. Undertake works related with housing reform. Undertake other tasks assigned by CFDI.
