Functional configuration of the State Drug Administration、Internal institutions and personnel preparation regulations

Article 1 The "Decision on Deepening the Reform of the Party and State Organizations" by the Third Plenary Session of the 19th Central Committee of the Party、"Deepening the Reform Plan for the Party and the State Institution" and the "State Council Institutional Reform Plan" approved by the first meeting of the 13th National People's Congress,Formulate this regulation。

Article 2 The State Drug Administration is the National Bureau of the State Administration of Market Supervision and Administration,is deputy ministerial level。

Article 3 The State Drug Administration implements the policy and decision -making deployment of the Party Central Committee on the supervision and management of drug supervision,Persist in and strengthen the party's centralized and unified leadership of the party's supervision and management of drugs。The main responsibility is:

(1) Responsible for drugs (including Chinese medicine、National Medicine,The same below)、Medical Device and Cosmetics Safety Supervision and Management。Plan for formulating supervision and management policy,Organize draft laws and regulations for drafting,Due to formulate departmental rules,and supervise the implementation。Research to formulate encouraging medicines、Management and service policy of new products and service policies for new technology and new technologies for medical devices。

(2) Responsible for medicine、Medical Device and Cosmetics Standard Management。Organization formulation、Announced National Pharmacopoeia and other medicines、Medical Device Standards,​​Organization to formulate cosmetics standards,Organization formulate a classification management system,and supervise the implementation。Participate in the formulation of a national basic drug directory,Cooperate with the implementation of the national basic drug system。

(3) Responsible for medicine、Medical Device and Cosmetics Registration Management。Formulate the registration management system,Strict listing review approval,Perfect the convenience measures for review and approval service,Organize implementation。

(4) Responsible for medicine、Medical equipment and cosmetics quality management。Formulate the development of quality management specifications and supervise the implementation。Formulate production quality management specifications and supervise implementation in accordance with duties。Formulate operation、Use quality management specifications and guide implementation。

stake online sports betting(stake online sports betting5) Responsible for medicine、Risk management after listing of medical devices and cosmetics。Organize adverse drug reactions、Monitoring of bad events and cosmetics adverse reactions、Evaluation and disposal。Undertake medicines in accordance with the law、Medical equipment and cosmetics safety emergency management work。

(6) Responsible for the qualification admission management of practicing pharmacists。Formulate the qualification access system for practicing pharmacist,Guide to supervise the registration of the pharmacist。

(7) Responsible for organizing guidance drugs、Medical Device and Cosmetics Supervision and Inspection。Formulate inspection system,Check the medicine in accordance with the law、13997_14014,Organization and investigation of production links in accordance with the duty illegal act。

(8) Responsible for medicine、External exchanges and cooperation in the field of medical equipment and cosmetics supervision and management,Participate in the formulation of relevant international regulatory rules and standards。

(9) Responsible for guiding the province、Autonomous Region、Work of the drug supervision and management department of municipality directly under the Central Government。

(10) Complete the Party Central Committee、Other tasks assigned by the State Council。

(11) Functional transformation.

1. In -depth promotion of simplified administration and decentralization。Reduce specific administrative approval items,Gradually advertise for drugs and medical equipment、Drug Clinical Test Institution、Imported non -special use cosmetics and other approval matters canceled or changed to record。Classified management of new raw materials for cosmetics,Permit management of high risk,Low risk implementation filing management。

2. Strengthen the post -event and post -event supervision。Perfect medicine、Medical Device All Life Cycle Management System,Strengthen the quality and safety risk management of the whole process,Innovation supervision method,Strengthen credit supervision,Comprehensively implement "Double Random、One Open "and" Internet+Supervision ",Improve regulatory efficiency,Meet the needs of public medication in the new era。

3. Effectively improve service level。Accelerate innovative medicines、Medical Device Review Approval,Establishing a listing license holder system,Promoting electronic review review approval,Optimized process、Improve efficiency,Create incentive innovation、Protection of legitimate rights and interest environment。Published drug registration application information in time,Guide applicants orderly research and development and declaration。

4. Comprehensively implement regulatory responsibility。According to the "most rigorous standard、The strictest supervision、The strictest punishment、The most serious accountability "requirements,Perfect medicine、Medical equipment and cosmetics review、Check、Test、Monitoring and other systems,Improve the professionalization level of the supervision team。Accelerate the consistency evaluation of the quality and efficacy of generic drugs,Promoting the construction of traceability system,Implement the main responsibility of the enterprise,Prevention system、Regional risk,Guarantee medicine、Medical equipment is safe and effective。

(12) division of responsibilities.

1. Relevant responsibilities of the State Administration of Market Supervision and Administration。The State Drug Administration is responsible for formulating drugs、Medical equipment and cosmetics supervision stake betting appstake betting appsystem,Responsible for medicine、License of the development of medical equipment and cosmetics、Check and punishment。Provincial drug supervision and management department is responsible for drugs、License of medical equipment and cosmetics production links、Check and punishment,and drug wholesale license、Retail chain headquarters permit、Internet sales third -party platform filing and inspection and punishment。Municipal and county market supervision departments are responsible for drug retail、licenses of medical device operation、Check and punishment,and cosmetics operation and medicine、Inspection and punishment of quality of medical equipment。

2. The division of responsibilities of the National Health and Health Committee。The State Drug Administration, together with the National Health Council, organizes the National Pharmacopoeia and formulates the national pharmacopoeia,Establishing major pharmaceutical adverse reactions and the mutual notification mechanism and joint disposal mechanism of adverse incidents of medical equipment。

3. The division of responsibilities of the Ministry of Commerce。The Ministry of Commerce is responsible for developing the development plan and policy of drug circulation,The State Drug Administration in the drug supervision and management,Cooperation with the development plan and policy of implementing drug circulation。The Ministry of Commerce issued a license before the import license of the drug -like toxic chemicals,The consent of the State Drug Administration should be obtained。

4. Division of responsibilities with the Ministry of Public Security。The Ministry of Public Security is responsible for organizing guidance drugs、Investigation of medical equipment and cosmetics crimes。The State Drug Administration and the Ministry of Public Security established an administrative law enforcement and criminal judicial work connection mechanism。The drug supervision and management department found that illegal acts are suspected of crime,Public security organs in time in accordance with relevant regulations,Public security organs should quickly review,and make a decision to file a case or not be able to establish a case in accordance with the law。Public security organs ask the drug supervision and management department to make inspection、Appraisal、Identification and other assistance,The drug supervision and management department shall assist。

Article 4 The State Drug Administration has set up an in -line set up (Deputy Division Bureau level):

(1) Comprehensive and Planning Finance Division。Responsible for the daily operation of the organs,Responsible information、Safety、Secret、Letter and visit、Government Affairs Open、Informatization、News Propaganda。Formulate and organize the implementation of development planning and special construction plan,Promoting the construction of the supervision and management system。Undertaking agencies and direct units budget budget、Finance、State -owned asset management and internal audit work。Organize the drafting comprehensive manuscripts and important conference documents。

(2) Policy and Regulations Division。Research drugs、Medical equipment and cosmetics supervision and management major policies。Organize the draft laws and regulations and departmental regulations for drafting,The legitimate review of the regulatory documents。Undertake law enforcement supervision、Administrative Reconsideration、Administrative response work。Undertake administrative law enforcement and criminal judicial connection management work。undertaking the publicity work of law popularization。

(3) Drug Registration Management Department (Chinese Medicine National stake betting appMedicine stake online sports bettingSupervision Management Department)。Organization to formulate and supervise the implementation of national pharmacopoeia and other drug standards、Technical Guidance Principles,It is planned to formulate and implement the drug registration management system。Supervision and implementation of quality management specifications for drug non -clinical research and clinical trials、Traditional Chinese Medicine Drinking Film Specification,Protection system for the implementation of traditional Chinese medicine varieties。undertake the organizational implementation of the classification management system、Check the development site、Investigate and deal with relevant illegal acts。Participate in the formulation of a national basic drug directory,Cooperate with the implementation of the national basic drug system。

(4) Drug Supervision and Management Department。Organizational formulation and supervision of the implementation of drug production quality management specifications in accordance with their duties,Organization to formulate and guide the implementation of operations、Use quality management specifications。undertake organizational guidance of production site inspections、Organization investigating and dealing with major illegal acts。Organizational quality spot check inspection,Publish quality announcement regularly。Organize the monitoring of adverse reactions and deal with it in accordance with the law。Responsible for radioactive medicine、Anesthesiologically、Toxic drugs and psychiatric drugs、Pharmaceutical Easy toxic Chemical Supervision and Management。

(5) Medical Device Registration Management Department。Organization to formulate and supervise the implementation of medical equipment standards、Classification Rules、Naming rules and coding rules,It is planned to formulate and implement the medical device registration management system。Draw and supervise the implementation of the quality management specifications of clinical trials of medical devices、Technical Guidance Principles。undertake organizational inspection and development site、Investigate and deal with illegal acts。

(6) Medical Device Supervision and Management Department。Organizational formulation and supervision and implementation of medical device production quality management specifications in accordance with their duties,Organization to formulate and guide the implementation of operations、Use quality management specifications。undertake organizational guidance of production site inspections、Organization investigating and dealing with major illegal acts。Organizational quality spot check inspection,Publish quality announcement regularly。Organize the monitoring of adverse events and deal with it in accordance with the law。

(7) Cosmetics Supervision and Management Department。Organize the implementation of cosmetics registration and filing work。Organization to formulate and supervise the implementation of cosmetics standards、Classification Rules、Technical Guidance Principles。undertake the cosmetics inspection system、Check the development site、Organize the production site inspection according to the responsibility organization、Investigate and deal with major illegal acts。Organizational quality spot check inspection,Publish quality announcement regularly。Organize the monitoring of adverse reactions and deal with it in accordance with the law。

(8) Technology and International Cooperation Department (Hong Kong, Macao and Taiwan Office)。Organization research and implementation medicine、Medical equipment and cosmetics review、Check、Scientific tools and methods of inspection,Research to formulate the management and service policy of encouraging new technology and new products。Draw and supervise the implementation of the laboratory construction standard and management specifications、Qualification Conditions and Inspection specifications for inspection and testing agencies。Organize and implement major science and technology projects。Organize international exchanges and cooperation,and exchanges and cooperation with Hong Kong, Macao stake betting appstake online sports bettingand Taiwan。Coordinating the formulation of international regulatory rules and standards。

(9) Personnel Department。Cadre personnel of the organs and direct units、Institutional preparation、Labor salary and education,Guide related talent team building。Undertake the qualification management work of a practicing pharmacist。

Organ Party Committee。The party and mass work responsible for the organ and the units directly under Beijing。

Retirement Cadre Bureau。Responsible for the work of retired cadres of the organs,Guide the retired cadre directly under the guidance。

5 The administrative establishment of the State Drug Administration of the State Drug Administration (including 2 members of the two committees、2 places for supporting mobile motors、Twenty of the staff of retired cadres compile)。4 deputy directors,4 deputy directors,Drug Safety Director 1,6 Drug Inspection Commissioner 6,The number of deputies and deputy directors 32 (including 1 full -time deputy secretary of the party committee of the government),The number of leaders of the retired cadre bureau 2。

Settings of the public institutions affiliated to the State Drug Administration、Responsibilities and preparation issues separately。

Article 7 This provision shall be explained by the Office of the Central Organization Committee,The adjustment of its adjustment shall be handled by the Office of the Central Organization Committee in accordance with the prescribed procedures。

Article 8 This provision shall be implemented from July 29, 2018。