Each province、Autonomous Region、The Food and Drug Administration of the Municipal Food and Drug Administration，Xinjiang Production and Construction Corps Food and Drug Administration:

  To implement the Central Committee of the Communist Party of China、The State Council's "Outline of the Implementation of the Construction of the Government of the rule of law (2015-2020)"，Comprehensively strengthen the construction of the rule of law for the food and drug supervision system，Actively promote the administration of the food and drug regulatory authorities，Realize the construction goals of the rule of law in the food and drug supervision system as scheduled，Actual rule of law construction for the current food and drug supervision system，Formulate this implementation opinion。

  1. Overall target

  Earnestly implement the 18th National Congress of the Communist Party of China and the 2nd Middle School of the Eighteenth Grade、Three Middle School、Fourth Middle School、Fifth Plenary Session and General Secretary Xi Jinping's series of important speeches，and the "Decision of the Central Committee of the Communist Party of China on the Outline of the Implementation of the Implementation of the Government of the rule of law (2015-2020)" for the "Decision of the Central Committee of the Communist Party of China on the rule of law" and，Implement innovation、Coordination、Green、Open、Share development concept，Safety of ensuring public dietary medicine around the public，Adhere to scientific legislation、Deep Popular Law、Consciously abide by the law、Strict law enforcement，Comprehensively strengthen the construction of the rule of law for the food and drug supervision system，Further improve the level of rule of law and drug supervision。

  By 2020，The overall goal of the rule of law construction of the food and drug supervision system is: scientific and complete food and drug safety legal system system is basically completed，High -quality professional regulatory team is basically established，The spirit of the rule of law、The concept of the rule of law and the rule of law have been deeply popularized，Clear functions、Law enforcement strict、Public fair、Integrity and efficient food and drug supervision department Basic completion。

  2. Main tasks and specific measures

  (1) Accelerate the construction of the legal system of food and drug supervision

  1. Improve the working mechanism of food and drug supervision。Further improve the legislative procedure of food and drug supervision，Improve the project、Draft、Research、Coordination、Review and other mechanisms，Scientificization of promoting food and drug supervision and legislation、Refined，Further enhanced the timelyness of legislative work、Systematic、Treatment and effectiveness; actively carry out pre -evaluation of food and drug legislation，Establish and improve major legislative project demonstration and public solicitation system，Explore the draft of the rules entrusted to draft regulations; organize the evaluation of food and drug legislation，Research and analysis of outstanding issues in the implementation of laws and regulations and regulations，Do a good job of revising related work in time; insist on establishing reform and abolition，By the end of 2018，Complete the modification、Abolition of rules that are not adapted to the development of the food and drug industry development and supply -side structural reforms，Construction of Legislative and Reform Decisions、Connection，To achieve reform in the law，Promoting reform in accordance with the law。

  2. Accelerate the legislative progress of the laws and regulations and regulations of food and drug supervision。Strengthening the top -level design of the Food and Drug Legal System System，Scientific formulation legislative planning and annual legislative plan，Strive constraints of enhanced legislative plan。Cooperate with the State Council's Legal Affairs Office，Strive to revise the "Regulations on Implementation of the Food Safety Law of the People's Republic of China" by the end of 2016。Actively promote the "Drug Management Law of the People's Republic of China" (hereinafter referred to as the "Drug Management Law")，Strive to submit a revised draft to the State Council for consideration by the end of 2016。By 2020，Food、Drug、Medical Device、Cosmetics laws and regulations and supporting rules system revision tasks are basically completed。

  3. Speed ​​up the judicial interpretation of improving the punishment of food and drug crimes。Actively cooperate with the Supreme People's Court、Supreme People's Procuratorate，Strive to introduce judicial interpretation of the clinical data of severe punishment drugs by the end of 2016，Completion of the "Explanation of Several Issues on the Application of Laws for Food Safety Criminal Cases" by the end of 2017, "Explanation of Corresponding Issues on Criminal Criminal Cases of Drug Safety"，Increase the crackdown on food and drug crimes。

  4. Actively promote the legislation of local food and drug supervision。Encourage and support local food and drug regulatory authorities to participate in the revision of local regulations and regulations on food and drug supervision，Guidance Promoting localities to accelerate the completion of food production and processing workshops、Food Safety Legislative Mission。Symposium on Local Food and Drug Supervision and Legislative Legal Works every year、Exchange Meeting，Timely summarizing local legislative experience，Promote local food and drug supervision legislation，Innovative food and drug supervision method and method。

  5. Strengthen the legality review of the standardized documents of food and drug supervision。Establish and improve the standardized document formulation procedures for food and drug supervision，Implementation of standardized documents by the legal institution of the food and drug regulatory authorities。The standardized documents formulated by the food and drug supervision departments at all levels at all levels shall be filed with the government legal department in accordance with regulations，and copy to the superior food and drug supervision department。Strengthen the construction of filing review，Increase the filing Stake Sports Bettingreview strength，Incorporate all normative files into the scope of the review，There is a must -see，If there is something wrong, it must be corrected。Specification files must not set administrative licenses、Administrative Punishment、Administrative Compulsory and other matters，Do not lose damage to citizens、Legal rights and interests of legal persons and other organizations or increase their obligations。Involved in citizens、Normal documents of the rights and obligations of legal persons and other organizations，It should be announced in accordance with statutory requirements and procedures。Unpublished，Not as a basis for regulatory law enforcement。Public lawyers of the Food and Drug Supervision Department shall undertake the unit in accordance with relevant regulations、The relevant work of the legality review of the regulatory documents of the headquarters。

  6. Speed ​​up the standardization of food and drug regulatory documents。According to the needs of the development of food and drug safety，and the revision of the relevant laws and regulations，Timely clean up relevant specified documents。Implementation of food and drug supervision standardized file directory and text dynamic management，Depending on the rules、Standardized documents to be used to make adjustments to the directory and text in a timely manner and announce to the society。Careful implementation of food and drug regulatory specification documentation plan。By the end of 2016，Completed the Cleanline Mission of Food and Drug Supervision from 2013 to 2015，By the end of 2018，Complete the cleansing task of standardized documents before 2013，Clean up the result and announce to the society in time。

  7. Improve the participation of the public and legislative public of food and drug supervision。Actively expand the ways and methods of the orderly participation of the orderly participation of food and drug safety supervision and legislation。Establish an expert demonstration consulting system，Important legal system system revision or major interest adjustment，Experts and scholars、Social Group、The opinions and suggestions of legal consultants。The regulatory system to be set involved in the manager of the management of the counterparts or the masses，or there is a large difference in opinion differences in related parties，Take a symposium、Analysis Meeting、Hearing and other forms widely listen to opinions and suggestions;、CPPCC member opinion system; improve the mechanism of soliciting opinions from the society，Improve the feedback mechanism of public opinion adoption。Except for confidentiality required in accordance with the law，Laws and regulations and regulations must pass the government website、Newspaper and other media publicly solicited opinions from the society，The deadline is generally not less than 30 working days。

  (2) Implement the requirements of simplified administration and decentralization and decentralization.

  8. In -depth promotion of the reform of the administrative approval system of food and drugs。Persist in the combination of decentralization、Stand -up，Plan to cancel、Decentralization and adjustment of administrative approval items，and announce to the society in time。For the reserved administrative approval items，Performance management，Unified approval standard，Simplified approval procedures，Standardize the approval process; strive to settle in strict accordance with the legal time limit。Further use the advantages of online review and approval，Gradually expand the scope of online review and approval，Improve the effectiveness of review and approval。Cooperate with the relevant departments to comprehensively clean up and standardize the approval of food and drug review approval intermediary services，By the end of 2016，Implement a list of management of the reserved food and drug review approval intermediary service matters and announce to the society。In accordance with the requirements of the State Council's reform of the review and approval system of drug medical device review，Implementation of drug registration classification reform，Completion of the pilot work of the holder system for the completion of the drug listing permit，Promoting the consistency evaluation of the quality and efficacy of generic drugs，Accelerate the review and approval of new drugs with clinical value and imitation drugs that are urgently needed by clinicals，Strengthening drug clinical trial supervision，Guarantee drug quality and safety from the source; improve the category of medical device categories，Establishing a dynamic adjustment mechanism for medical device categories，Improve the scientific and applicability of the standard of medical device，Optimized medical device review and approval process，Strengthen clinical trial supervision and management，Encourage medical device research and development innovation。Implementation of the General Administration of the General Administration on strengthening and decentralizing administrative examination and approval matters to strengthen the supervision of post -event and post -event supervision，Increase the supervision intensity of the post -deployment of administrative examination and approval of the decentralization。

  9. Promote the list of food and drug supervision power list、Responsibility list system and implement dynamic management。Organization combing law enforcement functions、permissions、Program、Responsibility，Clarifying law enforcement powers，Preparation to optimize the operation process of administrative law enforcement，Clarifying the responsibility matters corresponding to the supervision power、Responsible subject and responsibility method，Establish a list of power and list of responsibilities and disclose it to the society。Strive before the end of 2016，Food and drug supervision departments at all levels in accordance with the requirements of the reform of the administrative approval system at the same level，Public power list and responsibility list to the society，15507_15523。

  (3) Promote the scientificization of administrative decision -making of food and drug supervision、Democratization、rule of law

  10. Improvement of food and drug safety supervision according to law。Improve stake online sports bettingThe major administrative decision -making procedures for food and drug supervision，Decision Movement、Public participation、Expert demonstration、Technical consultation、Risk assessment、Legal review、Collective discussion decision and other systems are determined to be a must -have for food and drug regulatory major administrative decisions。Major administrative decision -making matters related to food and drug supervision related to the public interest，According to the requirements stipulated by laws and regulations，Implement publicity、Hearing system，Expand the public participation。Establish a major administrative decision -making internal legitimacy review mechanism，The major administrative decision -making items that the food and drug regulatory authorities are planned，Must be reviewed by the legitimacy of the legal institution。Without legitimacy review or illegal review，No discussion and decision must be submitted。By the end of 2016，Introduction to the Administrative Measures for Consultation of Drug Review Experts。

  11. Improve the legal consultant system for food and drug supervision。Establishing personnel with the legal institutions of the regulatory authorities as the main body、Legal consultant team participated by law and lawyers。Discussion、Decisions before major administrative decision -making matters，Carefully listen to the legal opinion of the legal consultant。Drafting、Research on the draft and standardized documents of relevant laws, regulations and regulations，Shapes should be asked to participate in or listen to the opinions of legal consultants。Matters that have not been listened to the legal consultants in accordance with relevant regulations，or the legal adviser believes that illegal and unsatisfactory matters，No discussion and decision must be submitted。By the end of 2016，Introduce the Management Measures for the Legal Advisor of the State Food and Drug Administration。By the end of 2018，Food and drug supervision departments at all levels generally establish a legal advisory system。

  (4) Adhere to strict, standardized, fair, civilized law enforcement

  12. Improve the food and drug supervision law enforcement procedures。Refined food and drug administrative law enforcement procedures，Standardize the administrative penalty of food and drugs、Administrative Compulsory、Administrative Inspection、Administrative charges and other behaviors。Implementation of the entire process of enforcement process，Improve law enforcement survey evidence collection rules，The entire process of law enforcement can be checked。According to the provisions of the food and drug administrative penalty procedures，Strictly regulate the jurisdiction of administrative punishment、Filtering Case、Investigation evidence、Punishment Decision、Delivery、Execution and other procedures。Implementing the daily supervision and inspection management system of food and drug production and operation，Strictly regulate supervision and inspection matters and specific requirements for supervision and inspection，Standardization and standardization of strengthening supervision and inspection。Establish and improve the benchmark system for administrative tailoring，Refined、The scope of administrative tailoring、Type、amplitude。By the end of 2017，The General Administration issued the application of administrative penalties for administrative penalties for the food and drug supervision system; before the end of 2018，Provincial Bureau issued a standard for administrative penalties for food and drugs in the region。Improve administrative law enforcement and criminal judicial connection mechanism，Strengthen information release communication and coordination，Realizing administrative penalties and seamlessly criminal justice。Improve the review system of major law enforcement legal system，Provide legal support to regulatory work，Unparalleled or unprepared，Do not make a decision。

  13. Strengthen the guidance of system food and drug supervision law enforcement。The superior food and drug supervision department must strengthen the guidance of the law enforcement work of lower -level food and drug regulatory departments，Establishing a law enforcement file review system，Specific case file archive，Organization to carry out experience in case handling。By the end of 2017，The General Administration issued the implementation of the implementation of the guidance system of food and drug supervision cases。By the end of 2018，All provincial bureaus complete the compilation and organize typical cases，Strengthen the coordination guidance of major difficult cases，Enhanced major difficult case analysis and argument。By the end of 2017，The General Administration of Food and Drug Supervision and Law Enforcement Evil Evil Rules Guidelines，Reinforcement evidence collection、Evidence Analysis、Evidence Acceptance and Evidence Application，Improve the awareness of the law enforcement evidence of the whole system。Actively promotes law enforcement matters、Mild Quie Sevenging、A prominent question interview、Visit of major cases、Flexible law enforcement methods such as law enforcement documents，Improve the level of case handling。Strengthen the construction of law enforcement information，By 2020，Building a unified information platform for food and drug supervision and law enforcement，Improve online law enforcement case handling and information query system，Implement information sharing，Promote law enforcement linkage and regional cooperation in various places。

   (5) Deepen the publicity and education of the rule of law in food and drugs

  14. Scientific formulation of food and drug supervision seven -five -Pu Law plan。Actively carry out theoretical research of food and drug safety rule of law，Persist in problem -oriented，To solve the outstanding problems existing in supervision practice。By the end of 2016，​​Food and drug supervision departments at all levels should formulate food and drug supervision seven -five -Pu law plan，Vigorously carry out publicity and education activities of law popularization，Implementing who enforces the law of law enforcement and the law of popularizing law，Popular law publicity education and food and drug science education、Food and Drug Safety Propaganda and other activities combined，Rich Law Content and Form，A good atmosphere of the rule of law created food and drug safety social governance。

  15.。Food and drug supervision departments at all levels must vigorously publicize the "Food Safety Law of the People's Republic of China" (hereinafter referred to as the "Food Safety Law")、"Drug Management Law"、"Regulations on the Supervision and Management of Medical Devices"、"Regulations on the Supervision and Administration of Cosmetics" and other laws and regulations，Fully realized that laws and regulations such as "Food Safety Law" and "Drug Management Law" are important laws to ensure the safety of people's dietary medicines，It is the basic basis for law enforcement of food and drug supervision departments，It is the basic behavioral standard for food and drug companies and their practitioners。Current and future period，Food and drug supervision departments at all levels must always take the study and publicity of the "Food Safety Law" and "Drug Management Law" and other laws and regulations as an important task，Learn publicity and education through in -depth systems，Deep grasp of the spiritual essence of the legal system of food and drug safety and the connotation of legal provisions，Use a good legal weapon，Effectively ensure the safety of public dietary medicine。

  (6) Strengthen the restriction and supervision of food and drug supervision power

  16. Fully promote the disclosure of food and drug supervision government affairs。According to the requirements of the "Regulations on the Disclosure of Government Stake Sports BettingInformation"，Adhere to the public as the normal state、Uninterrupted the exception principle，Comprehensively publicize administrative law enforcement functions to the society、Legal basis、Implementation subject、Responsibilities permissions，Public Supervision Method、Supervision results and other matters，Guarantee the right to informed the company and the public、Participation right、Supervision right。Promoting the open informationization of government affairs，Improve routine release、Policy interpretation、Hotel response and other mechanisms，Broaden information disclosure channel，Do a good job of public opinion guidance for hot sensitive issues，Timely response to social concerns。Continuous improvement according to the disclosure of government information，Clear process of handling the process，Specification Acceptance、Delivery、Handling、Transfer and answering links，Improve the quality of information。

  17.。Strengthen the restrictions on the internal power of the department，Administrative license、Administrative Punishment、Administrative Inspection and review approval、Inspection and detection、Monitoring Evaluation、Audit and inspection, departments and positions that are concentrated in power, implement shared ownership、Delivery、Hierarchical authorization，Strengthen internal process control，Prevention of power abuse。Comprehensive implementation of administrative law enforcement responsibility system，By the end of 2017，Food and drug supervision departments at all levels should further improve the responsibilities and work process of food and drug supervision and law enforcement positions，Use supervision and inspection、Case Paper Review、Questionnaire survey and other methods，Effectively improve the effectiveness of department -level supervision; formulate accounting methods for food and drug supervision and law enforcement，Resolutely correct administrative inaction、Chaos，Resolutely overcome laziness、Yongzheng、Police，Resolutely punish lost office、Mansion。

  (7) Effectively resolve the social contradictions and disputes of the social conflict of food and drug supervision

  18. Give full play to the role of social supervision and public opinion supervision。Improve the registration system for reporting of illegal administrative behavior of food and drug supervision at all levels，Unblocked report box、Electronic mailbox、Supervision channels such as hotline telephone，Convenient for complaints on illegal administrative acts，Investigate and deal with illegal administrative behavior in time in accordance with the law。According to the principle that the supervisor is responsible，Carry out letters and visits in accordance with the law，Solving the legal and reasonable demands of guarantee。Consciously accept social supervision，Organization of problems reflected in all aspects、Investigation and verification and timely feedback processing results。Give play to newspapers、Broadcast、TV and other traditional media supervision functions，Strengthen interaction with emerging media such as the Internet，Pay attention to the use and standardize network supervision，Establish and improve online public opinion monitoring、Collection、Research and judgment、disposal mechanism，Promote the standardization of network supervision、rule of law。

  19. Strengthen the administrative reconsideration and responding work of food and drug safety。Improve the work mechanism of the trial of administrative reconsideration cases，Correct illegal or improper administrative acts，Improve the quality of administrative reconsideration cases，Professionalism of enhanced administrative reconsideration、Transparency and credibility。Food and drug supervision departments at all levels must strengthen the construction of administrative reconsideration capabilities，Promote the setting of relevant agencies、Personnel equipment is compatible with the task that it takes，Give full play to the important role of administrative reconsideration in solving administrative disputes。Actively do a good job of administrative response，The person in charge of the food and drug regulatory department shall appeal in court in accordance with the law，Can't appear in court，The corresponding staff of the department should be entrusted to appear in court。Consciously performing the effective judgment made by the People's Court、Ruling。

   (8) Comprehensively improve the thinking and administrative ability of the rule of law and administrative ability of food and drug supervision and law enforcement personnel

  20. Establish an employment orientation that values ​​the literacy and the ability of the rule of law。Grasp the key minority of leading cadres of the food and drug supervision department，Strong concept of rule of law、The rule of law is not well raised as an important criterion for measuring cadre virtue，Whether it can abide by the law、Affairs of doing things in accordance with the law as an important content for investigating cadres。Improve the system mechanism of the selection and appointment of leading cadres，Under the same conditions，Prefer the use of the rule of law to raise well、Cadres who have strong ability to work in accordance with the law。Perfect the punishment system，Implementing accountability，serious thought to privileges、Cadres with weak concepts of the rule of law must criticize education、Understand rectification，The problem is serious，Disciplinary according to law and discipline。Explore the establishment of the assessment system of the trinity of leading cadres at all levels，Requirements for describing and honesty，Key evaluation units and personal learning law respects the law、major matters decision -making according to law and strict administration in accordance with the law。

  21. Strengthen the rule of law education and training of food and drug supervision and law enforcement personnel。Food and Drug Supervision Law Enforcement Officer, especially leading cadres, should systematically learn the theory of socialist rule of law with Chinese characteristics，Learn the constitution and laws and regulations of food and drugs。Improve the system of learning，The General Administration and Provincial Bureau held at least one period of at least one phase of no less than 40 hours of leading cadres.，The leadership team of food and drug supervision departments at all levels should participate in a special lecture on the rule of law for more than two issues each year。Improve the job training system for food and drug supervision and law enforcement personnel，Organize the common legal knowledge of administrative law enforcement officers every year、Food and Drug Supervision Professional Legal Knowledge、New laws and regulations and other special training。Increase the initial training of civil servants、Training for legal knowledge in the training training。

  22.。Strengthen the legal knowledge test and the test of administrative capabilities in accordance with the law for leading cadres，Test and test results as an important reference stake online sports bettingfor leading cadres，Promoting food and drug supervision and law enforcement personnel strictly fulfill the responsibilities of the construction of the rule of law。Use a variety of forms such as the Training Platform of the National Food and Drug Supervisory Cadres Network Training College，Strengthening the ability of the rule of law for food and drug supervision and law enforcement personnel。Implementing a civil servant promoted administrative assessment system in accordance with the law。

  23. Public lawyer work of food and drug supervision is generally carried out。In accordance，Comprehensively carry out public office lawyers at the food and drug supervision system。Public office lawyers provide legal consultation to the food and drug regulatory department where the food and drug supervision department is located，Participate in the headquarters law、Regulations、Drafting of rules and regulatory documents、Modify，Acting departments participating in administrative reconsideration and administrative litigation。The business management of public lawyers is responsible for the legal department，There are many departments with more public lawyers，Establishing chief public lawyer and public office lawyer management office。At the end of 2016，The General Administration of the General Administration is equipped with a public office lawyer，By the end of 2018，Local food and drug regulatory departments at all levels to complete public office lawyers。

  3. Organizational guarantee and implementation mechanism

  24. Strengthen the organization and leadership of the rule of law of food and drug supervision。Food and drug supervision departments at all levels established a leading group of rule of law construction led by the principals，The main person in charge is the first responsible person in the construction of the rule of law in all units。The party group (committee of the food and drug supervision departments at all levels) shall include the construction of the rule of law in an important agenda，Review of the annual work plan of the rule of law construction of the unit of food and drug，Report on the construction of the rule of law of the rule of law at least twice a year，Research to solve major problems in the construction of food and drug safety。

  25. Strengthen the assessment and evaluation of the construction of the rule of law, supervision and inspection。Food and drug supervision departments at all levels must incorporate the effectiveness of the construction of the rule of law into the performance assessment index system，Give full play to the important promotion role of the evaluation and evaluation on the construction of the rule of law in the supervision of food and drugs。Outstanding performance，To give commendation and rewards; poor work、More questions，Discuss in time、Order rectification、Report criticism。

  26. Strengthen the construction of grass -roots food and drug law enforcement teams。Give full play to the basic role of grass -roots regulators in promoting the construction of the rule of law，Enhance the concept of the rule of law of grassroots law enforcement officials，Improve administrative ability according to law。Strengthen the legal literacy and job ability training of law enforcement personnel。Formation of food and drug administrative law enforcement standards，Disguise law enforcement officers in order to pretend to be a wind discipline。Strengthening overall planning，Strengthen resource investment，Organization to promote the construction experience of grass -roots food and drug supervision agencies。

  27. Implement the guarantee of food and drug supervision law enforcement funds。Food and drug supervision departments at or above the county level should be under the leadership of the local government，Establish a normal law enforcement funding guarantee mechanism。Actively strive for local government support，Make food and drug supervision law enforcement work funds incorporate into the government's annual budget，Resolutely eliminate administrative law enforcement and unit、Phenomenon of personal economic interests。Improve the grass -roots facilities of the food and drug supervision department、Law enforcement equipment and inspection and testing conditions，Effectively carry out the effective development of food and drug supervision。

  28. Strengthen the construction of food and drug regulatory legal institutions。Promoting the regularization of the legal team、Professional construction。Food and drug supervision departments at or above the county level shall actively strive to set up legal institutions，Grassroots Food and Drug Division Institutions shall be equipped with a dedicated part -time legal personnel。Staff of the legal institution should have a legal education background，Getting legal professional qualifications。To increase the cultivation of the staff of the legal institution、Use and exchange strength，Give full play to the organizational coordination and supervision and guidance role of legal institutions in the construction of the rule of law。

Food and Drug Administration

August 8, 2016