CFDA: the draft drug administration law is expected to be submitted to the State Council by the end of the year

Source: on August 15, 2016, CFDA released the implementation opinions of the General Administration on Comprehensively Strengthening the legal construction of the food and drug regulatory system With regard to the revision of the drug administration law, CFDA said it would strive to submit the revised draft to the State Council for deliberation before the end of this year In 2020, we will complete the basic formulation and revision of laws and regulations and supporting regulations on food, drugs, medical devices and cosmetics The following is the full text of the implementation opinions on Comprehensively Strengthening the construction of the rule of law in the food and drug regulatory system: the food and Drug Administration of each province, autonomous region and municipality directly under the central government, and the food and Drug Administration of Xinjiang production and Construction Corps: in order to implement the implementation of the outline for the construction of a government under the rule of law (2015-2020) issued by the CPC Central Committee and the State Council 》To comprehensively strengthen the legal construction of the food and drug supervision system, actively promote the legal administration of the food and drug supervision department, and achieve the goal of the legal construction of the food and drug supervision system on schedule I The overall goal is to conscientiously implement the spirit of the series of important speeches of the eighteen and eighteen second, third, fourth, fifth, and fifth plenary session of the party and general secretary Xi Jinping, as well as the decision of the CPC Central Committee on several major issues of comprehensively promoting the rule of law and the implementation outline of the rule of law government (2015 to 2020) 》It is required to implement the development concept of innovation, coordination, green, opening and sharing, adhere to scientific legislation, in-depth law popularization, consciously abide by the law, and strictly enforce the law, comprehensively strengthen the legal construction of the food and drug regulatory system, and further improve the legal level of food and drug regulatory By 2020, the overall goal of the legal construction of the food and drug supervision system is: the scientific and complete legal system of food and drug safety has been basically established, the high-quality professional supervision team has been basically established, the spirit of the rule of law, the concept of the rule of law and the thinking of the rule of law have been deeply popularized, and the food and drug supervision departments with clear functions, strict law enforcement, open and fair, honest and efficient have been basically established 2、 The main tasks and specific measures are as follows: (1) accelerate the construction of the legal system of food and drug supervision; (2) improve the legislative mechanism of food and drug supervision We will further improve the legislative procedures for food and drug supervision, improve the mechanisms for setting up projects, drafting, demonstrating, coordinating and deliberating, promote the scientization and refinement of the legislative work for food and drug supervision, and further enhance the timeliness, systematization, pertinence and effectiveness of the legislative work; Actively carry out pre legislation evaluation of food and drug, establish and improve the system of demonstration of major legislative projects and public consultation, explore and entrust a third party to draft rules and regulations; organize post legislation evaluation of food and drug, study and analyze the outstanding problems in the implementation of laws and regulations, and timely do a good job in revising related work; Adhere to the simultaneous development of legislative reform, Abolishment and interpretation By the end of 2018, complete the revision and abolishment of regulations that do not meet the requirements of the development of the food and drug industry and the supply side structural reform Ensure that the legislation and reform decisions are unified and linked, so that the reform is based on the law, and the reform is carried forward in accordance with the law 2 Accelerate the legislative progress of laws, regulations and rules on food and drug supervision We should strengthen the top-level design of the construction of the legal system of food and drug, scientifically formulate the legislative plan and annual legislative plan, and strengthen the rigid constraints on the implementation of the legislative plan Cooperate with the Legal Affairs Office of the State Council, and strive to revise and issue the regulations on the implementation of the food safety law of the people's Republic of China and the regulations on the supervision and administration of cosmetics by the end of 2016 We will actively promote the revision of the drug administration law of the people's Republic of China (hereinafter referred to as the drug administration law), and strive to submit the revised draft to the State Council for deliberation by the end of 2016 By 2020, the task of formulating and revising laws, regulations and supporting regulations on food, drugs, medical devices and cosmetics will be basically completed 3 Accelerate the improvement of the judicial interpretation of punishing food and drug crimes Actively cooperate with the Supreme People's court and the Supreme People's Procuratorate, and strive to issue a judicial interpretation on severely punishing drug clinical data fraud by the end of 2016, 2017 Before the end of each year, we will complete the revision of the interpretation on Several Issues concerning the application of laws in handling criminal cases against food safety and the interpretation on Several Issues concerning the application of laws in handling criminal cases against drug safety, and intensify the fight against food and drug crimes 4 Actively promote local food and drug regulatory legislation Encourage and support local food and drug regulatory authorities to participate in the formulation and revision of local laws and regulations on food and drug regulation, guide and promote local governments to accelerate the completion of local food safety legislative tasks such as small food production and processing workshops, food vendors and small restaurants Every year, a symposium and exchange meeting on the legislation of local food and drug supervision will be held to summarize the experience of local legislation in a timely manner, to promote the local government to accelerate the legislation of food and drug supervision, and to innovate the methods of food and drug supervision 5 Strengthen the legitimacy review of normative documents of food and drug supervision Establish and improve the procedures for the formulation of regulatory documents for food and drug administration, and implement the requirements for the legality review of regulatory documents by the legal institutions of food and drug administration The normative documents formulated by the local food and drug regulatory authorities at all levels shall be filed with the legal department of the government and copied to the food and drug regulatory authorities at higher levels We will strengthen the capacity-building of record keeping and review, increase the strength of record keeping and review, and bring all normative documents into the scope of review, so as to make sure that there is a case that must be checked and that there is a mistake that must be corrected Normative documents shall not set matters such as administrative permission, administrative punishment and administrative coercion, and shall not derogate from the legitimate rights and interests of citizens, legal persons and other organizations or increase their obligations Normative documents concerning the rights and obligations of citizens, legal persons and other organizations shall be published in accordance with legal requirements and procedures Those that have not been published shall not be used as the basis for supervision and law enforcement The public lawyer of the food and drug regulatory department shall, in accordance with the relevant provisions, undertake the relevant work of the legality review of the normative documents of the unit and the Department 6 Speed up the cleaning of regulatory documents of food and drug administration According to the needs of the development of food and drug safety situation, as well as the revision of relevant laws and regulations, timely clean up the relevant normative documents To implement the dynamic management of the contents and texts of the normative documents for food and drug supervision, the contents and texts shall be adjusted in a timely manner and released to the public according to the rules and regulations and the situation of the waste of the normative documents Conscientiously implement the cleaning plan of normative documents of food and drug supervision By the end of 2016, the task of cleaning up normative documents of food and Drug Administration from 2013 to 2015 will be completed, and by the end of 2018, the task of cleaning up normative documents before 2013 will be completed, and the cleaning results will be released to the society in time 7 Improve public participation in food and drug regulatory legislation Actively expand ways and means for all parties to participate in food and drug safety supervision and legislation in an orderly manner We will establish a system of expert argumentation and consultation, formulate and revise important legal systems or adjust major interests, and extensively solicit opinions and suggestions from experts, scholars, social organizations and legal advisers If the proposed supervision system involves the vital interests of the management counterpart or the masses, or there are major differences of views in relevant aspects, the opinions and suggestions shall be widely heard in the form of symposiums, argumentation meetings, hearings, etc.; the system of drafting laws and regulations and soliciting opinions from deputies to the national people's Congress and members of the political association shall be improved; We will improve the mechanism for soliciting public opinions and the feedback mechanism for the adoption of public opinions In addition to the need for confidentiality according to law, the draft laws and regulations shall be open to the public for comments through government websites, newspapers and other media, with a general period of no less than 30 working days （2） We will implement the reform requirements of streamlining administration, delegating authority, delegating management, and optimizing services 8 We will deepen the reform of the food and Drug Administration approval system We should adhere to the principle of combining and simultaneously releasing management, cancel, delegate and adjust administrative examination and approval items in a planned way, and publicize them to the public in a timely manner For the reserved administrative examination and approval items, the catalogue system management shall be implemented, the examination and approval standards shall be unified, the examination and approval procedures shall be simplified, and the examination and approval process shall be standardized; all the administrative examination and approval items shall be completed in strict accordance with the legal time limit We will further give play to the advantages of online review and approval, gradually expand the scope of online review and approval, and improve the effectiveness of review and approval Cooperate with relevant departments to comprehensively clean up and standardize the intermediary services for food and drug review and approval By the end of 2016, implement inventory management on the retained intermediary services for food and drug review and approval and make them known to the public In accordance with the requirements of the State Council on the reform of the review and approval system for pharmaceutical and medical devices, we will implement the reform of drug registration and classification, complete the pilot work of the drug listing license holder system, promote the evaluation of the consistency of the quality and efficacy of generic drugs, accelerate the review and approval of new drugs with clinical value and the urgently needed generic drugs, strengthen the supervision of drug clinical trials, and ensure the source Drug quality and safety; improve the classification catalog of medical devices, establish a dynamic adjustment mechanism of medical device categories, improve the scientificity and applicability of medical device standards, optimize the review and approval process of medical devices, strengthen the supervision and management of clinical trials, and encourage innovation in medical device research and development We will implement the opinions of the State Administration on strengthening in-process and post supervision over the cancellation and decentralization of administrative examination and approval, and strengthen in-process and post supervision over the cancellation and decentralization of administrative examination and approval 9 Implement the power list and responsibility list system of food and drug supervision and implement dynamic management Organize and sort out the functions, authorities, procedures and responsibilities of law enforcement, clarify the matters of law enforcement power, prepare and optimize the operation process of administrative law enforcement, clarify the matters of responsibility, the subjects of responsibility and the ways of responsibility corresponding to the supervision power, establish the list of power and responsibility and make it public to the society By the end of 2016, the food and drug regulatory authorities at all levels shall, in accordance with the requirements of the government at the same level on the reform of the administrative examination and approval system, make the list of powers and responsibilities open to the public, and make dynamic adjustments in accordance with laws and regulations （3） Promote the scientific, democratic and legal administrative decision-making of food and drug supervision 10 Improve the legal decision-making mechanism of food and drug safety supervision We will improve the major administrative decision-making procedures of food and drug supervision, and make the decision-making motion, public participation, expert argumentation, technical consultation, risk assessment, legality review, collective discussion and decision-making system the necessary procedures for major administrative decision-making of food and drug supervision For major administrative decision-making matters of food and drug supervision closely related to the public interest, the publicity and hearing system shall be implemented in accordance with the requirements of laws and regulations to expand public participation Establish an internal legitimacy review mechanism for major administrative decisions The food and drug regulatory authorities shall review the legality of major administrative decisions to be made by legal institutions Those who have not been examined for legality or are illegal after examination shall not be submitted for discussion and decision-making By the end of 2016, the administrative measures for consultation of drug review experts will be promulgated 11 Improve the legal advisory system of food and drug supervision We will establish a legal advisory team with legal personnel of regulatory departments as the main body and legal experts and lawyers as participants Before discussing and deciding on major administrative decision-making matters, we should carefully listen to the legal opinions of the legal counsel In the process of drafting and demonstrating the draft laws, regulations and normative documents, legal advisers shall be invited to attend or listen to their opinions For matters that should be listened to by legal counsel in accordance with relevant regulations but not listened to,