Medical network - on August 9, 2016, to fully implement the party's 18 large and 18th session of 2, 3, 4, fifth plenary session of the spirit, and xi jinping, general secretary of the series of important speech spirit, the food and drug supervision administration (hereinafter referred to as "administration") in accordance with "the central committee of the communist party of China on promoting the rule of law certain major issue decision" and "the rule of law government construction implementation summary (2015-2020)" (hereinafter referred to as the outline) requirements, to strengthen the construction of the food and drug supervision system of the rule of law in an all-round way, adhere to the scientific legislation, strict law enforcement, further the franco-prussian, promoting administration according to law of the food and drug regulatory authorities, each work has made significant achievements. The progress of the work is reported as follows:
Strengthening the organization and leadership of the construction work of the rule of law
For the full implementation of the outline requirements, administration of the party group attaches great importance to, is mainly responsible for promoting the construction of the rule of law conscientiously fulfill the responsibility of the person in charge of the first multiple instructions require combining the reality of the food and drug administration of the rule of law construction, accelerate the process of construction of the rule of law.
In 2016, the administration issued the about comprehensive implementation opinions to strengthen the construction of the food and drug supervision system of the rule of law "(hereinafter referred to as the" implementation opinion "), specific to the food and drug supervision of the construction of the rule of law in 2020 the overall goal is: scientific and perfect legal system of food and drug safety basic completion of the professional regulatory team basic establishment, the spirit of the rule of law, the rule of law concept and law thinking is further popularization, function clear, strict law enforcement, open and fair, honest and efficient food and drug regulators basic completion. The implementation of the guidelines clarifying the eight major tasks and 23 specific measures of the legal construction of the food and drug regulatory system, and put forward specific requirements and measures for the mechanism of organization guarantee and implementation. To promote the food and drug supervision of the rule of law construction, in accordance with the requirements of the opinion that administration a year of the rule of law construction points, clear responsibility division, division of tasks, time node, guarantee results can implement, inspection.
Second, we will accelerate legislation on food and drug regulation
One is to complete the amendment to the regulations on the circulation and prevention of vaccination. Actively cooperate with the legislative affairs office of the state council, complete the revised regulation on the administration of the circulation of vaccines and vaccination, and further implement the vaccine production, circulation, inoculation and so on each link regulatory responsibilities, plug up loopholes in supervision.
The second is to accelerate the revision of the regulations on the implementation of the food safety law of the People's Republic of China. In July 2016, the general administration reported to the state council the draft amendment to the law on the implementation of the food safety law of the People's Republic of China.
Third, promote the revision of the cosmetics supervision and administration ordinance. Organizing international symposium on cosmetics regulation and legislation, supervision legal system construction of cosmetics workshops, actively cooperate with the state council legislative affairs office to speed up the process of revised regulations on the supervision and administration of cosmetics.
Fourth, the law on drug administration of the People's Republic of China has been steadily promoted. Revision of the "drugadministration law of the People's Republic of China" is listed as the 12th session of the standing committee of the National People's Congress legislation for five years planning projects, the state council on drug file after review of medical equipment examination and approval system reform, administration organized experts and scholars, industry association and drug research and development, production, circulation enterprises to carry out the discussion, again and again modification, is now the fourth draft revision draft, strive to complete the draft report before the end of the work. At the same time, actively cooperate with the formulation of the Chinese medicine law of the People's Republic of China.
Fifth, we will accelerate the revision of departmental regulations. Introduced in 2016, the quality and safety of edible agricultural products market supervision and management measures for the food and drug complaint reporting measures for the administration of the health food registration and filing management method ", "food production or marketing daily supervision and inspection measures for the administration of the special purpose of medicine formula registration measures for the administration of the medical device clinical trials and the quality control standard for the infant formula milk product formula registration measures for the administration of the Internet investigation method on food safety violations administration of the state food and drug supervision and administration on modifying the decision of the management quality management > < drugs" and so on nine rules. Since the establishment of the general administration, 33 regulations have been revised, and the regulatory system of food and drug administration has been improved.
Sixth, strengthen normative documents to review and clean up. Since the establishment of the general administration, nearly 300 normative documents have been cleaned up, and the opinions on retention, invalidation and invalidation have been put forward, and public consultation has been made public. Has complete administration of regulatory documents to clear the first batch of food and drug regulation work (2013-2015), published on the announcement of the first batch of regulatory documents to clear the results of, 22 pieces of normative documents abolished or failure.
Seven is to promote the "two high" judicial interpretation revision. To punish drug, medical device registration process the data in the fraud, actively promote the "projects" to study and draft "about to deal with drugs, medical devices registration data fraud criminal cases to explain some issues of applicable law. At the same time, actively coordinate "projects" to speed up the revision on the handle criminal cases endangering food security to explain some issues of applicable law on the food and drug dispute cases provisions on some issues of applicable law.
Deepen the reform of the administrative examination and approval system
The first is to increase administrative approval and cancellation, decentralization. Administration under the state council to the newspaper to check and revise send proposed to cancel the three central designated place to implement the administrative licensing matters, including the provinces (autonomous regions and municipalities) food and drug administration on the implementation of pharmaceutical excipients (excluding drugs with auxiliary materials and import of medicinal materials) to register for examination and approval, the Internet for examination and approval of pharmaceutical trading service enterprises (except for the third party platform), drug clinical trial institution qualification first trial, the department of state has issued cancelled. Administration under the state council to the newspaper to check and revise send to cancel the drug clinical trial institution qualification, medical instrument clinical trial institution qualification, Internet drug trading service enterprise (the third party platform) for examination and approval of 3 items of administrative examination and approval matters, the state council to check and revise and expert discussion meeting has been through. Among them, the recent announcement of the decision of the state council on revising the > of the regulations on medical devices supervision and administration has changed the qualification of medical device clinical testing institutions into filing management.
Second, actively advance the integration of the two certificates. According to the newly revised "food safety law of the People's Republic of China, administration of dusting" food business license management method ", the original food circulation permit and the catering service license merge two license for food business licenses licensing item 1. At the same time, in conjunction with the state health and family planning commission issued by the food and drug supervision administration and national health and family planning commission of integral adjustment catering service place public hygiene license and food business license matters related to notice (food drug safety supervisor 2 [2016] no. 29), cancel the restaurant, cafe, bar, teahouse and other places of four kinds of food and beverage service of hygiene license, the relevant license content into the food business license review standards; Issued by the food and drug supervision administration of catering service place public hygiene license and food business licenses after consolidation adjustment notice food business license matters related to the condition of (food drug safety supervisor 2 [2016] no. 109), to further simplify the approval process and conditions. As of now, the general administration has cancelled, delegated and adjusted 11 major items, 5 minor items, 24 existing administrative approval items and 41 local administrative examination and approval items.
Third, standardize the review and approval procedures. For the implementation of the state council about the opinions of the drug review of medical equipment examination and approval system reform "(guo fa [2015] 44) requirements, the administration has launched pilot, carry out drug marketing authorisation holder system to carry out the drug clinical trial data consistency check, to carry out the quality of generic drugs and curative effect evaluation of nearly 30 supporting reform measures, such as further simplify examination and approval procedures for the review, improve the efficiency of review for examination and approval, the reform task effectively.
Fourth, strengthen the post-mortem regulation. Set the food and drug supervision bureau to cancel and handed over the opinions of the administrative examination and approval matters strengthen the regulation of things afterwards ", clear down and undertake to the specific requirements of the administrative examination and approval matters, for the food and drug regulatory system in the reform of administrative examination and approval, insist on the pipes, strengthen the regulation of things afterwards, seriously implement the responsibilities for all parties. Introduced the food and drug supervision administration on further random inspection to strengthen the food and drug safety matter later regulatory notice, for the food and drug supervision law enforcement matters, the implementation of the requirements of the "double random, a public".
The fifth is to vigorously implement the list of powers. Timely announce "power list", to set the administrative examination and approval items based on, object of examination and approval, examination and approval department, basis and standards of charges and the agency and staffing administration of network and of the central government website of the public to the society. At the same time, to check and revise request under the state council, administration service guide and the detailed rules for the review of administrative examination and approval items, listed set basis, application conditions, application materials, the basic process, the time limit for examination and approval, charge basis, attached prominently public demonstration text on the site, and to accept the place, to check and revise do audit released by the state council.
Fourth, promote the scientific and legal decision-making of administrative decision-making
First, improve the administrative decision-making mechanism in accordance with the law. In order to ensure the administrative decision-making scientific and democratic, under the rule of law, administration of the expert argumentation, technical consulting, risk evaluation, legitimacy examination, the collective discussion and decision to determine the necessary to make a major administrative decision-making procedure. The review mechanism of the internal legality of major decisions is emphasized, and the regulatory authorities must review the legality of major administrative decisions. Introduced to improve the scientific level of decision-making, administration of the state food and drug supervision and administration of outside experts management approach (trial) ", the administration of state food and drug supervision and management of special medical purpose formula registration review expert database management approach (trial) "the evaluation expert advisory committee for drug registration management method (trial)", give full play to the external experts in the review of examination and approval, the key role of daily supervision.
Second, steadily advance legal advisory work. To establish an expert team of legal advisers and put in place the administrative measures on the administration of legal counsel of the state food and drug administration. Under the strict recommendation selection procedure, the general administration employs 14 well-known experts and lawyers from the academic and practical circles to serve as legal advisers to the general administration of the general administration. The advisory group gathers the senior legal experts of administrative jurisprudence, jurisprudence, civil jurisprudence, criminal jurisprudence and legal practice to escort the scientific and legal supervision of food and medicine. At the same time, according to the work needs of the bureaus and the professional background of legal counsel, the establishment of the legal adviser's mechanism for the communication of the department, and the two or three legal advisers who are in contact with the departments of the general administration of the general administration. When the business council meets the legal matters needing to be resolved, it can contact the legal counsel and obtain legal help. Administration full attention legal adviser "think tank" play "extended mind", in the legislation, the major administrative decision-making, emergency handling, reply and administrative reconsideration responses to government information disclosure work of actively participating in legal adviser, legal risk assessment, to listen to your legal expert advice, guarantee the administration of the administrative action in accordance with the rules according to the procedures in accordance with the law, to safeguard the interests of all parties, effectively reduce regulation lead to conflicts and resolve the legal risks.
Third, we will actively promote the system of public service lawyers. Business department, issued the national food and drug supervision system to carry out the public lawyers work plan, for the food and drug supervision office the lawyer's qualifications and responsibilities, the rights and obligations of public law, public law work management system and management responsibility, public law terminate the practice situation, office job security and other aspects of the specification, has strong practical. To introduce the administrative measures for the administration of the state administration of food and drug administration. At present, the general administration has 24 employees who have obtained a public qualification certificate.
Fifth, adhere to strict and fair civilization law enforcement
One is to clarify supervisory responsibilities. To promote grassroots, strict, fair and civilized law enforcement, put the food and drug supervision administration on strengthening food and drug supervision and administration departments at the county level and its dispatched institutions on food safety law enforcement standardization guidance ", from the perfect the institutions, clear voice, specification from eleven aspects, such as the administrative licensing for the food and drug supervision and administration departments at the county level and its dispatched institutions on food safety law enforcement standardization construction make that clear. To fully implement the central about the food and drug safety "four of the most severe" requirements, to further improve the food and drug supervision administration takes office in accordance with the ability and level of commitment, on the food and drug supervision bureau on further strengthening legal administration started a good job guidance ".
Second, improve the administrative law enforcement responsibility system. Through the organization to carry out the administrative law enforcement jobs, formulating the administrative law enforcement responsibility and work procedures, clear the specific duties of different law enforcement, law enforcement posts, responsibility to people, standardize power operation. According to requirement of administration of provinces, autonomous regions and municipalities directly under the food and drug administration issued the interim provisions on administrative law enforcement responsibility system of administrative enforcement evaluation measures for the examination of the administrative law enforcement measures for illegal responsibility shall be investigated for the system of administrative law enforcement supervision and inspection, etc., clear internal institutions and the administrative law enforcement responsibility, establishing and perfecting the administrative law enforcement responsibility system and the appraisal system, make the administrative law enforcement responsibility system has according to the can depend on.
Third, increase law enforcement. In order to strengthen the regulation on the new business state of the Internet food, the measures to investigate the illegal behavior of online food safety are introduced. Daily supervision of fortified food production and operation, release the food production license management method "" food production or marketing daily supervision and inspection management method" "food production or marketing risk classification management method (trial)", to promote the implementation of food production enterprise risk classification management, speed up the construction of food safety traceability system. At the same time, it focuses on infant formula milk powder and innovates to carry out systematic examination.
Fourth, carry out law enforcement inspection. We cooperated with the standing committee of the National People's Congress and completed the law enforcement inspection of the food safety law of the People's Republic of China. Zhang dejiang, chairman of the standing committee of National People's Congress (NPC) and the four, vice chairman of the lead, to the eight provinces (autonomous regions and municipalities) to inspect, the administration of the four leaders attended the law enforcement inspection, we will accelerate the food safety related important problems to solve. At the same time, in order to strengthen the grassroots law enforcement, the law enforcement public and law enforcement regulation is the key, the organization carries out the annual law enforcement inspection of the whole system. On the basis of self-inspection, the on-site sampling was conducted on 8 provinces (district, city), 20 municipal, 22 county-level food and drug administration and more than 40 township supervision. We attach great importance to the universality and outstanding issues of discovery, formulate strong measures, and urge all local governments to rectify them in time.
Strengthen the restriction and supervision on administrative power
One is to increase the disclosure of information. To protect the public right to know of the food and drug safety, right of participation, expression and supervision, in accordance with the law of the People's Republic of China government information disclosure regulations requirements, adhere to the public as the norm, not publicly as exception principle, to the social public administrative law enforcement responsibility, implementing subject, duty right, etc. The government's website has become an important window for the release of supervision information and other regulatory information. At the same time, continue to improve the government information disclosure work, according to application for the food and drug supervision administration of the government information public work according to application specification "(food drug safety office [2015] no. 171), clear, process specification acceptance, assigned by, to undertake, complaint and reply link, improve the quality of information disclosure. To study and draft the food and drug safety supervision information management method ", to further standardize, specific approval, registration, supervision and sampling inspection, daily supervision and administrative law enforcement supervision in the process of information content, time limit, manner.
Second, improve supervision and restriction mechanism. Administration by means of food safety assessment, the press to carry out the administrative law enforcement responsibility system, strengthen the internal power restriction, to the administrative licensing, administrative punishment, administrative examination and review, inspection testing, monitoring and evaluation of examination and approval, audit, inspection, etc
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