CFDA英文

About CFDAMain ResponsibilitiesDraft laws, regulations and rules and policy plans on the administration and supervision of food (including food additives and health food, the same below) safety, drugs (including traditional Chinese medicines andethno-medicines, the same below), medical devices and cosmetics; formulate normative documents, and facilitate the establishment and implementation of the food safety responsibility mechanism, under which food companies shall bear the main responsibility and local people's governments shall take integrated responsibility;establish the direct reporting system for critical food and drug information and supervise its implementation;take measures to reduce risks on regional and systemic food and drug safety;Formulate the regulations on food administrative licensing and supervise their implementation; establish food safety risk management mechanism, formulate annual plans for nation-wide inspection for food safety and programs for major control actions, and organize their implementation; establish the unified food safety information release system and release information on important food safety issues; participate in formulating food safety risk monitoring plans and food safety standards, and undertake food safety risk monitoring thereon;Organize the formulation and publication of the national pharmacopeia, other drug and medical device standards and classification system, and supervise their implementation; develop good practices on research, production, distribution and use of drugs and medical devices, and supervise their implementation; undertake drug and medical device registration, supervision and inspection; establish monitoring system for adverse drug reactions, adverse events of medical devices, and undertake monitoring and response activities; draw up and improve regulations and qualifications for licensed pharmacists, guide and supervise the registration work; participate in formulating national essential medicine list and assist its implementation; formulate administrative provisions for cosmetics administration and supervise their implementation;Formulate the investigation and enforcement system for food, drugs, medical devices and cosmetics, and organize their implementation; organize the investigation and punishment on major violations; establish recall and disposal system for defect products, and supervise the implementation;Establish food and drug emergency response system, organize and guide the emergency response and investigation on food and drug safety incident, and supervise the implementation of investigation andpunishment;Formulate science and technology development plans for food and drug safety, and organize theirimplementation; accelerate the construction of food and drug testing system, electronic supervision tracking system, and information system;Undertake the public communication, education and training, and international exchanges and cooperation in the field of food and drug safety; promote the establishment of credibility system;Guide food and drug administration works of local governments, regulate administrative activities, and improve the interlocking mechanism between administrative enforcement and criminal justice;Undertake the routine work of the Food Safety Commission of the State Council; take charge of comprehensive coordination on food safety administration, facilitate and improve the cooperation and coordination mechanism; supervise the work of provincial people's governments on food safety administration, and evaluate their performance;Undertake other work assigned by the State Council and the Food Safety Commission of the State Council.Internal StructureGeneral OfficeComprehensive Department (Office of Policy Research)Department of Legal AffairsDepartment of Food Safety Supervision IDepartment of Food Safety Supervision IIDepartment of Food Safety Supervision IIIDepartment of Drug and Cosmetics Registration (Department of TCMs and Ethno- Medicines Supervision)Department of Medical Device RegistrationDepartment of Drug and Cosmetics SupervisionDepartment of Medical Device SupervisionBureau of Investigation and EnforcementDepartment of Emergency ManagementDepartment of Science, Technology and StandardsDepartment of Media and PublicityDepartment of Human ResourcesDepartment of Planning and FinanceDepartment of International Cooperation (Office of Hong Kong, Macao and Taiwan Affairs)General OfficeTo be responsible for routine operation of documentation and communication, meeting affairs, confidential work, archive management, superintendence, etc.; and government information disclosure, security and confidentiality affairs, dealing with letters and calls, etc.There are five divisions:4 Division of General Affairs4 Division of Secretariat I (Office of Duty)4 Division of Secretariat II4 Division of Documentation & Communication4 Division of Superintendence (Office of Letters and Calls)Comprehensive Department(Office of Policy Research)To undertake the routine work of the Food Safety Commission Office of the State Council; supervise the work of relevant departments and provincial people's governments on food safety administration, and evaluate their performance; to conduct research on important policies and draft important document on food, drug, medical device and cosmetics administration.There are four divisions:Division of General CoordinationDivision of Policy Research IDivision of Policy Research IIDivision of Supervision and Evaluation (Office of Statistics)Department of Legal AffairsTo organize the drafting of laws, regulations and provisions; to examine and verify the legality of normative documents; to undertake the administrative enforcement, administrative reconsideration, and administrative respondence, etc.There are four divisions:Division of General AffairsDivision of Regulations IDivision of Regulations IIDivision of Enforcement Supervision(Office of Administrative Reconsideration) Department of Food Safety Supervision ITo track and analyze food safety situation and existing problems at the production stage, and to put forward recommendations on system, mechanism and performance improvement; to supervise the low-level administrative departments in conducting administrative licensing by law, in performing the administrative duty, in detecting and rectifying illegal and improper acts in time.There are five divisions:Division of General AffairsDivision of Supervision IDivision of Supervision IIDivision of Supervision IIIDivision of Supervision IVDepartment of Food Safety Supervision IITo track and analyze food safety situation and existing problems at distribution and consumption stages, and to put forward recommendations on system, mechanism and performance improvement; to supervise the low-level administrative departments in conducting administrative licensing by law, in performing the administrative duty, in detecting and rectifying illegal and improper acts in time.There are five divisions:Division of General AffairsDivision of Supervision IDivision of Supervision IIDivision of Supervision IIIDivision of Supervision IVDepartment of Food Safety Supervision IIITo undertake food safety statistic work, analyze and predict general trend on food safety, organize and carry out the food safety risk early warning and communication; to take part in formulating food safety risk monitoring plan, and perform food safety risk monitoring thereon.There are five divisions:Division of General AffairsDivision of Supervision IDivision of Supervision IIDivision of Supervision IIIDivision of Supervision IVDepartment of Drug and Cosmetics Registration(Department of TCMs and Ethno-Medicines Supervision)To conduct drug registration and issue administrative licenses for certain categories of cosmetics in strict accordance with the conditions and procedures prescribed by law, take the correspondent responsibilities, optimize registration and administrative licensing control procedures, supervise the implementation of good practices for drug non-clinical studies, drug clinical trials, and TCM preparation slices processing, and implement the TCM species protection system.There are six divisions:Division of General AffairsDivision of Traditional Chinese Medicines and Ethno-MedicinesDivision of PharmaceuticalsDivision of Biological ProductsDivision of Drug Research SupervisionDivision of CosmeticsDepartment of Medical Device RegistrationTo conduct registration for Class III and import medical devices in strict accordance with the conditions and procedures prescribed by law, take the correspondent responsibilities, optimize registration control procedures, organize and implement classification administration, and supervise the implementation of good practices for medical devices.There are four divisions:Division of General AffairsDivision of Registration IDivision of Registration IIDivision of Research SupervisionDepartment of Drug and Cosmetics SupervisionTo track and analyze drug and cosmetics safety situation and existing problems, and to put forward recommendations on system, mechanism and performance improvement ; to supervise the low-level administrative departments in conducting administrative licensing by law, in performing the administrative duty, in detecting and rectifying illegal and improper acts in time; to undertake supervision of radio-active drugs, narcotics, toxics and psychotropics, and pharmaceutical precursor chemicals, etc.; to organize and conduct adverse drug reaction monitoring and drug reevaluation.There are six divisions:Division of General AffairsDivision of Drug Manufacturing SupervisionDivision of Drug Distribution SupervisionDivision of Drug Monitoring and Re-evaluationDivision of Controlled Drug SupervisionDivision of Cosmetics SupervisionDepartment of Medical Device SupervisionTo track and analyze medical device safety situation and existing problems, and to put forward recommendations on system, mechanism and performance improvement; to supervise the low-level administrative departments in conducting administrative licensing by law, in performing the administrative duty, in detecting and rectifying illegal and improper acts in time; to organize and conduct medical device adverse events monitoring and reevaluation.There are four divisions:Division of General AffairsDivision of Manufacturing SupervisionDivision of Distribution SupervisionDivision of Monitoring and Re-evaluationBureau of Investigation and EnforcementTo organize the investigation and punishment on major and serious cases pertaining to food and drug safety; guide and supervise investigation and enforcement of local governments, regulate administrative activities, and improve the interlocking mechanism between administrative enforcement and criminal justice; supervise recall and disposal for defect products; to guide the local governments in examining and approving advertisements for drugs, medical devices, and health food.There are four divisions:Division of General AffairsDivision of Investigation and Enforcement IDivision of Investigation and Enforcement IIDivision of Investigation and Enforcement IIIDepartment of Emergency ManagementTo improve the food and drug safety emergency response system; to organize the formulation of emergency preparedness plan and carry out emergency response drills; to carry out the emergency response and investigation into major incidents on food and drug safety; to guide and coordinate the local governments in emergency response to food and drug safety incident.There are four divisions:Division of General AffairsDivision of Emergency MonitoringDivision of Emergency GuidanceDivision of Emergency ResponseDepartment of Science, Technology and StandardsTo organize and implement major science and technology programs for food and drug supervision, accelerate the construction of food and drug testing system, electronic supervision tracking system, and information system; to draft qualification requirements and testing norms governing food and drug testing institutions, and supervise their implementation; to organize the drafting of standards for drugs, medical devices, cosmetics, and catalogues, pharmaceutical use requirements, standards for immediate packaging materials and containers, and participate in the drafting of food safety standards.There are four divisions:Division of General Affairs (Division of Informationalization)Division of Science and TechnologyDivision of Standard ManagementDivision of Testing Institutes InstructionDepartment of Media and PublicityTo establish a unified information release system of food safety, and undertake public education and information release for food and drug safety.There are three divisions:Division of General AffairsDivision of Media and Publicity IDivision of Media and Publicity IIDepartment of Human ResourcesTo manage human resources, authorized institutional strength, capacity building and training of the head office and its affiliated institutions; draw up and improve regulations and qualifications for licensed pharmacists, guide and supervise the registration work.There are four divisions:Division of General Affairs (Division of Personnel Supervision)Division of PersonnelDivision of TalentsDivision of Affiliated Institutions (Division of Compensation)Department of Planning and FinanceTo draw up and implement the food and drug safety planning and organize its implementation; to manage the budget, accounting, finance, State-owned assets, and internal audit for the head office and affiliated institutions.There are four divisions:Division of General Affairs (Division of General Planning)Division of Construction and EquipmentDivision of Budget and AuditDivision of Finance and AssetsDepartment of International Cooperation(Office of Hong Kong, Macao and Taiwan Affairs)To organize and carry out international exchanges and cooperation, and exchanges and cooperation with Hong Kong, Macao, Taiwan in food and drug administration.There are four divisions:Division of General AffairsDivision of International OrganizationsDivision of Bilateral CooperationDivision of Hong Kong, Macao and Taiwan Affairs。