First, the functional transformation
The State Food and Drug Administration was established in accordance with the "Regulations on the Reform and Functional Transformation of the State Council" approved by the First Session of the 12th National People's Congress and the Notice of the State Council on the Establishment of Institutions (Guo Fa [2013] No. 14) (Front level), directly under the State Council.
First, the functional transformation
(1) The responsibility for cancellation.
1. The two administrative licenses for pharmaceutical production administrative license and pharmaceutical production quality management standard certification are gradually integrated into one administrative license.
2. The two administrative licenses for drug business administrative license and drug business quality management standard certification are gradually integrated into one administrative license.
3. The administrative license for cosmetics production and the administrative license for cosmetics and health are integrated into one administrative license.
4. Cancel the continuing education management duties of licensed pharmacists, and the work is undertaken by the China Association of Licensed Pharmacists.
5. Other duties that need to be cancelled in accordance with the State Council's Institutional Reform and Functional Transformation Program.
(2) Duties of decentralization.
1. Decentralize the responsibility for the quality management of pharmaceuticals and medical devices to the provincial food and drug supervision and administration department.
2. The provincial food and drug supervision and administration department shall be delegated to the administrative license of the supplementary application for re-registration of the drug and the intrinsic quality of the drug.
3. The domestic third-class medical equipment will be devolved to the provincial food and drug supervision and administration department without changing the intrinsic quality of the product.
4. The responsibility for entrusting the production of administrative licenses for drugs shall be delegated to the provincial food and drug supervision and administration department.
5. The responsibility for importing non-special-purpose cosmetics administrative licenses will be delegated to the provincial food and drug supervision and administration department.
6. Other duties that need to be decentralized in accordance with the State Council's Institutional Reform and Functional Transformation Program.
(3) The responsibility of integration.
1. The former Ministry of Health organized the responsibility of formulating the Drug Code and assigned it to the State Food and Drug Administration.
2. The responsibility of the former Ministry of Health to determine the qualification criteria for food safety inspection institutions and the formulation of inspection specifications shall be assigned to the State Food and Drug Administration.
3. The responsibility of the State Administration of Quality Supervision, Inspection and Quarantine for the administrative licensing and compulsory inspection of cosmetics production shall be assigned to the State Food and Drug Administration.
4. The responsibility of the National Quality Supervision, Inspection and Quarantine Bureau for medical device compulsory certification shall be assigned to the State Food and Drug Administration and included in the registration of medical devices.
5. Integrate the State Administration of Quality Supervision, Inspection and Quarantine and the food safety inspection and testing institutions of the former State Food and Drug Administration, promote the separation of management and management, realize resource sharing, establish a corporate governance structure, and form a unified food safety inspection and testing technology support system.
(4) Strengthened responsibilities.
1. Transform management concepts, innovate management methods, give full play to the market mechanism, social supervision and industry self-discipline, and establish an effective mechanism for production and operation operators to become the first responsible person for food and drug safety.
2. Strengthen the construction and comprehensive coordination of food safety systems, improve the drug standard system and quality management regulations, optimize drug registration and related administrative licensing management processes, improve food and drug risk warning mechanisms and local supervision and inspection mechanisms, and build preventive regional and systemic foods. The mechanism of drug safety risks.
3. Promote the integration of food and drug inspection and testing institutions, provide social inspection and testing services fairly, increase government procurement services, improve the technical support guarantee system, and improve the scientific level of food and drug supervision and management.
4. Standardize the administrative law enforcement actions of food and drug, improve the mechanism of effective connection between administrative law enforcement and criminal justice, and promote the efforts to increase the punishment of illegal food and drug crimes.
Second, the main responsibilities
(1) Responsible for drafting laws and regulations on food (including food additives, health foods, the same below) safety, medicines (including Chinese medicines, ethnic medicines, the same below), medical equipment, cosmetics supervision and management, formulating policy plans, and formulating departmental regulations. Promote the establishment of a mechanism for implementing the main responsibility of food safety enterprises and the overall responsibility of local people's governments, establish a direct reporting system for major information on foods and drugs, and organize implementation, supervision and inspection, and strive to prevent regional and systemic food and drug safety risks.
(2) Responsible for formulating the implementation measures for food administrative licenses and supervising their implementation. Establish a food safety hazard investigation and management mechanism, formulate a national food safety inspection annual plan, a major rectification plan and organize implementation. Responsible for establishing a unified food safety information disclosure system and publishing important food safety information. Participate in the formulation of food safety risk monitoring plans, food safety standards, and conduct food safety risk monitoring in accordance with the food safety risk monitoring program.
(3) Responsible for organizing the formulation and publication of standards and classification management systems for drugs and medical devices such as the National Pharmacopoeia and supervising their implementation. Responsible for formulating quality management regulations for the development, production, operation and use of pharmaceuticals and medical devices and supervising their implementation. Responsible for drug and medical device registration and supervision. Establish a monitoring system for adverse drug reactions, medical device adverse events, and carry out monitoring and disposal work. Formulate and improve the qualification system for licensed pharmacists, and guide the supervision of the registration of licensed pharmacists. Participate in the formulation of the national essential medicines catalogue and cooperate with the implementation of the national essential medicine system. Formulate measures for the supervision and management of cosmetics and supervise their implementation.
(4) Responsible for formulating the inspection system for the supervision and management of food, medicine, medical equipment and cosmetics, organizing and implementing, and organizing investigation and punishment of major illegal acts. Establish a problem product recall and disposal system and supervise implementation.
(5) Responsible for the construction of food and drug safety accident emergency system, organize and guide the emergency disposal and investigation and handling of food and drug safety accidents, and supervise the implementation of accident investigation and punishment.
(6) Responsible for formulating food biosafety science and technology development plans and organizing implementation, promoting food and drug inspection and testing systems, electronic regulatory traceability systems and informatization construction.
(7) Responsible for the promotion of food and drug safety, education and training, international exchanges and cooperation. Promote the construction of a credit system.
(8) To guide the supervision and administration of local food and drug, standardize administrative law enforcement, and improve the mechanism of administrative law enforcement and criminal justice.
(9) To undertake the daily work of the Food Safety Committee of the State Council. Responsible for the comprehensive coordination of food safety supervision and management, and promote a sound coordination and linkage mechanism. Supervise and inspect the provincial people's government to perform food safety supervision and management duties and be responsible for assessment and evaluation.
(10) To undertake other matters assigned by the State Council and the Food Safety Committee of the State Council.
Third, the internal institutions
According to the above responsibilities, the State Food and Drug Administration has 17 internal institutions:
(1) Office.
Responsible for the daily operation of the text, electricity, conference, confidentiality, archives, supervision and other institutions, and undertake government affairs disclosure, security and confidentiality and letters and visits.
(2) Comprehensive Division (Policy Research Office).
To undertake the daily work of the Office of the Food Safety Committee of the State Council and the assessment and evaluation of the duties of food safety supervision and management by relevant departments and provincial people's governments. Study major policies for food, drug, medical device, and cosmetics supervision and management, and draft important contributions.
(3) Legal Department.
Organize the drafting of laws and regulations and regulations, undertake the legality review of normative documents, and undertake administrative law enforcement supervision, administrative reconsideration, and administrative response.
(4) Food Safety Supervision Division I.
Master the analysis of the food safety situation and problems in the production process, and put forward suggestions for improving the system mechanism and improving the work, and urge the lower-level administrative organs to strictly implement the administrative licensing, perform supervision and management responsibilities according to law, and timely discover and correct illegal and improper behaviors.
(5) Food Safety Supervision Division II.
Master the analysis of the food safety situation in the circulation and consumption links, and put forward problems to improve the institutional mechanism and improve the work, and urge the lower-level administrative organs to strictly implement the administrative licensing, perform supervision and management responsibilities according to law, and timely discover and correct illegal and improper behaviors.
(6) Three Divisions of Food Safety Supervision.
To undertake food safety statistics, analyze and predict the overall situation of food safety, and organize food safety risk warning and risk communication. Participate in the development of a food safety risk monitoring program and conduct food safety risk monitoring based on the plan.
(7) Department of Pharmaceutical and Cosmetic Registration Management (Traditional Chinese Medicine Supervision Department).
Strictly comply with the conditions and procedures stipulated by laws and regulations, handle drug registration and some cosmetic administrative licenses and assume corresponding responsibilities, optimize the registration and administrative licensing management process, supervise the implementation of drug non-clinical research, drug clinical trial quality management standards, Chinese medicine decoction processing specifications, implementation Chinese medicine variety protection system.
(8) Medical Device Registration Management Division.
Strictly follow the conditions and procedures stipulated by laws and regulations to handle the registration of the third category of imported medical device products and assume corresponding responsibilities, optimize the registration management process, organize the implementation of classified management, and supervise the implementation of medical device quality management practices.
(9) Drug and Cosmetics Supervision Department.
Master the analysis of the safety situation of pharmaceuticals and cosmetics, existing problems, and put forward suggestions for improving the system and improving the work, and urge the lower-level administrative organs to strictly implement administrative licensing, perform supervision and management responsibilities according to law, and timely discover and correct illegal and improper behaviors. To undertake supervision and management of radioactive drugs, narcotic drugs, toxic drugs, psychotropic drugs, and drug precursor chemicals. Organize the monitoring and re-evaluation of adverse drug reactions.
(10) Medical Device Supervision Department.
Master the analysis of the safety situation of medical devices, existing problems, and put forward suggestions for improving the system and improving the work, and urge the lower-level administrative organs to strictly implement administrative licensing, perform supervision and management responsibilities, and timely discover and correct illegal and improper behaviors. Organize the monitoring and re-evaluation of medical device adverse events.
(11) Inspection Bureau.
Organize investigation and handling of major food and drug safety violation cases, guide and supervise local inspections, standardize administrative law enforcement behaviors, and promote the improvement of administrative law enforcement and criminal justice convergence mechanisms. Supervise problem product recalls and disposals. To guide the review of local medicines, medical equipment, and health food advertisements.
(12) Emergency Management Division.
Promote the establishment of a food and drug safety emergency response system, organize the preparation of emergency plans and conduct drills, undertake emergency handling and investigation and handling of major food and drug safety incidents, and guide the coordination of local food safety incident emergency response work.
(13) Technology and Standards Division.
Organize the implementation of major scientific and technological projects for food and drug supervision and management, and promote the food and drug inspection and testing system, electronic supervision and traceability system and information construction. Formulate qualification conditions and inspection specifications for food and drug inspection and testing institutions and supervise their implementation. Organize the development of standards for pharmaceuticals, medical devices, cosmetics, and packaging materials and containers for direct contact with pharmaceuticals, medicinal requirements, standards, and participate in the development of food safety standards.
(14) News and Publicity Department.
Formulate a unified system for the publication of food safety information, and undertake publicity, news and information dissemination of food and drug safety science.
(15) Personnel Division.
To undertake the personnel management, organization, team building and training of the organs and subordinate units. Formulate and improve the qualification system for licensed pharmacists, and supervise and guide the registration of licensed pharmacists.
(16) Planning and Finance Division.
Formulate food and drug safety plans and organize implementation. To undertake the final accounts, financial, state-owned assets management and internal audit of the organs and subordinate units.
(17) Department of International Cooperation (Hong Kong, Macao and Taiwan Office).
Organize international exchanges and cooperation in food and drug supervision and management, as well as exchanges and cooperation with Hong Kong, Macao and Taiwan.
Party committee of the government. Responsible for the work of the organs and the party groups directly under the Beijing government.
Retired cadre bureau. Responsible for the work of retired cadres and direct the work of retired cadres.
Fourth, staffing
The administrative department of the State Food and Drug Administration has a total of 345 administrative staff (including 2 staff members of the two committees, 2 mobile aid organizations, and 20 retired cadres). Among them: 1 director and 4 deputy directors, in order to establish a mechanism for the State Food and Drug Administration and the National Health and Family Planning Commission to strengthen the coordination and close coordination of medicines and medical care, and establish a deputy director to serve as national health and family planning. The deputy director of the committee; 60 directors (including 1 food safety director, 1 drug safety director, 1 full-time deputy secretary of the party committee, 2 retired cadres), and the National Food and Drug Inspection Commissioner 10 name.
V. Other matters
(1) The State Food and Drug Administration shall affix the office of the Food Safety Committee of the State Council.
(2) Division of responsibilities related to the Ministry of Agriculture. The agricultural department is responsible for the quality and safety supervision and management of edible agricultural products from the cultivation and breeding links to the wholesale, retail market or production and processing enterprises, and is responsible for the quality and use of other agricultural inputs such as pesticides, fertilizers, fertilizers and other veterinary drugs, feeds, feed additives and responsibilities. Supervise management. After the edible agricultural products enter the wholesale, retail market or production and processing enterprises, the foods shall be supervised and managed by the food and drug supervision and administration department. The agricultural department is responsible for the quality and safety supervision and management of the livestock and poultry slaughtering process and the raw milk purchase. The two departments established a food safety traceability mechanism, strengthened coordination and cooperation, and formed a joint force of supervision.
(3) Division of responsibilities related to the National Health and Family Planning Commission. 1. The National Health and Family Planning Commission is responsible for food safety risk assessment and food safety standards development. The National Health and Family Planning Commission, in conjunction with the State Food and Drug Administration and other departments, develops and implements a food safety risk monitoring plan. The State Food and Drug Administration shall promptly submit recommendations for food safety risk assessment to the National Health and Family Planning Commission. If the National Health and Family Planning Commission monitors food safety risks or receives reports that there may be potential safety hazards in food, it shall immediately organize inspection and food safety risk assessment, and promptly notify the State Food and Drug Administration of the food safety risk assessment results. . The State Food and Drug Administration shall take immediate measures for foods that have reached unsafe conclusions. If it is necessary to formulate and revise relevant food safety standards, the National Health and Family Planning Commission shall formulate and revise it as soon as possible. Improve the corporate governance structure of the National Food Safety Risk Assessment Center and improve the board system. 2. The State Food and Drug Administration, in conjunction with the National Health and Family Planning Commission, organizes the National Pharmacopoeia Commission to develop the National Pharmacopoeia. 3. The State Food and Drug Administration and the National Health and Family Planning Commission will establish a mutual notification mechanism and joint disposal mechanism for major adverse drug reactions.
(4) Division of responsibilities with the State Administration of Quality Supervision, Inspection and Quarantine. 1. The State Administration of Quality Supervision, Inspection and Quarantine is responsible for the supervision and management of the production and processing of food-related products such as food packaging materials, containers and food production and management tools. If the quality supervision department finds that food-related products may affect food safety, it shall promptly notify the food and drug supervision and administration department, and the food and drug supervision and administration department shall immediately take measures to deal with the food production and circulation consumption. The food and drug supervision and administration department found that food safety problems may be caused by food-related products, and should promptly notify the quality supervision department. The quality supervision department should immediately take measures to deal with the production and processing of food-related products. 2. The State Administration of Quality Supervision, Inspection and Quarantine is responsible for import and export food safety, quality supervision, inspection and supervision. Imported food and food-related products shall comply with China's national food safety standards. The General Administration of Quality Supervision, Inspection and Quarantine shall collect and summarize the import and export food safety information and promptly notify the State Food and Drug Administration. If a food safety incident occurred outside China may affect China's territory or if serious food safety problems are found in imported food, the State Administration of Quality Supervision, Inspection and Quarantine shall promptly adopt risk warning or control measures and notify the State Food and Drug Administration. The State Food and Drug Administration shall take corresponding measures in a timely manner.
(5) The division of responsibilities with the State Administration for Industry and Commerce. The food and drug supervision and administration department is responsible for the examination of the advertisement content of drugs, medical devices and health foods, and the administrative department for industry and commerce is responsible for the supervision and inspection of the advertising activities of drugs, medical devices and health foods. The food and drug supervision and administration department shall inspect the drugs, medical devices and health food advertisements approved by it. For illegal advertisements, it shall notify the administrative department of industry and commerce and put forward suggestions for handling them. The administrative department for industry and commerce shall handle the matter according to law, and the two departments shall establish and improve. Coordination and coordination mechanism.
(6) Division of responsibilities related to the Ministry of Commerce. 1. The Ministry of Commerce is responsible for formulating drug circulation development plans and policies. The State Food and Drug Administration is responsible for the supervision and management of drug circulation, and cooperates with the implementation of drug circulation development plans and policies. 2. The Ministry of Commerce is responsible for formulating plans and policies for promoting the development of catering services and alcohol circulation. The State Food and Drug Administration is responsible for the supervision and management of catering services for food safety and alcoholic food safety. 3. The Ministry of Commerce shall obtain the consent of the State Food and Drug Administration before issuing the import license for pharmaceutical precursor chemicals.
(7) Division of responsibilities with the Ministry of Public Security. The Ministry of Public Security is responsible for organizing and guiding the investigation of food and drug crime cases. The State Food and Drug Administration and the Ministry of Public Security have established a mechanism for linking administrative law enforcement and criminal justice work. If the food and drug supervision and administration department discovers that a food or drug illegal act is suspected of committing a crime, it shall promptly transfer it to the public security organ in accordance with relevant regulations. The public security organ shall promptly conduct a review and make a decision on filing the case or not filing the case. Where the public security organ submits to the food and drug supervision and administration department for assistance in inspection, appraisal, identification, etc., the food and drug supervision and administration department shall provide assistance.
(8) The establishment, responsibilities and preparation of the affiliated institution shall be separately stipulated.
Sixth, the supplementary
This regulation shall be interpreted by the Office of the Central Organizing Committee, and its adjustment shall be handled by the Office of the Central Organizing Committee in accordance with the prescribed procedures.