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    Home > Active Ingredient News > Drugs Articles > Report on the construction of the food and drug regulatory legal government in 2016

    Report on the construction of the food and drug regulatory legal government in 2016

    • Last Update: 2017-08-08
    • Source: Internet
    • Author: User
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    Source: CFDA 2017-08-08 In 2016, in order to fully implement the spirit of the eighteen and eighteen second, third, fourth and fifth plenary session of the party and the important speech of general secretary Xi Jinping, the General Administration of food and Drug Administration (hereinafter referred to as the General Administration) is in line with the decision of the CPC Central Committee on several major issues concerning comprehensively promoting the rule of law and the implementation outline of the rule of law government (2015 to 2020) It is required by the outline to comprehensively strengthen the legal construction of the food and drug regulatory system, adhere to scientific legislation, strict law enforcement, and in-depth law popularization, and actively promote the administration of food and drug regulatory authorities in accordance with the law, with remarkable results achieved in various work The progress of relevant work is reported as follows: first, strengthen the organizational leadership of the construction of the rule of law In order to fully implement the requirements of the outline, the Party group of the General Administration attaches great importance to it The main responsible comrades earnestly fulfill the responsibility of the first person responsible for promoting the construction of the rule of law, and many times of instructions require that the process of promoting the construction of the rule of law be accelerated in combination with the actual work of the construction of the rule of law in food and drugs In 2016, the General Administration of food and Drug Administration issued the implementation opinions on Comprehensively Strengthening the legal construction of food and drug supervision system (hereinafter referred to as the Implementation Opinions), which clearly stated that the overall goal of the legal construction of food and drug supervision by 2020 is: the scientific and complete legal system of food and drug safety has been basically completed, 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 rule of law has been deeply popularized, and the food and drug regulatory departments with clear functions, strict law enforcement, openness, fairness, integrity and efficiency have been basically established In the implementation opinions, 8 main tasks and 23 specific measures for the legal construction of the food and drug regulatory system are defined, and specific requirements and measures are put forward for the organizational guarantee and implementation mechanism In order to effectively promote the construction of the rule of law in food and drug supervision, according to the requirements of the implementation opinions, the General Administration issued the key points of the annual rule of law construction work, defined the responsible departments, task division and time nodes, and ensured that the results can be implemented and tested 2、 The first is to complete the revision of regulations on the administration of vaccine circulation and vaccination Actively cooperate with the Legal Affairs Office of the State Council, complete the revision of the regulations on the administration of vaccine circulation and vaccination, further implement the regulatory responsibilities of vaccine production, circulation, vaccination and other links, and plug the regulatory loopholes Second, we will accelerate the revision of the regulations for the implementation of the food safety law of the people's Republic of China In July 2016, the General Administration submitted the revised draft of the regulations for the implementation of the food safety law of the people's Republic of China to the State Council Third, we will promote the revision of the regulations on the supervision and administration of cosmetics Organize and hold an international seminar on cosmetics supervision and legislation, conduct a special discussion on the construction of cosmetics supervision legal system, and actively cooperate with the Legislative Affairs Office of the State Council to accelerate the revision process of regulations on cosmetics supervision and administration Fourth, the revision of the drug administration law of the people's Republic of China has been steadily promoted The revision of the drug administration law of the people's Republic of China has been listed as the five-year legislative planning project of the Standing Committee of the 12th National People's Congress After the issuance of the State Council's reform document on the review and approval system of medical devices, the General Administration has organized experts and scholars, industry associations and drug R & D, production and distribution enterprises for many times to hold symposiums, revise and improve them repeatedly At present, the fourth revision draft has been formed Draft and strive to complete the drafting and reporting work by the end of the year At the same time, actively cooperate with the formulation of the law of the people's Republic of China on Chinese medicine Fifth, speed up the formulation and revision of departmental regulations In 2016, measures for the supervision and management of quality and safety in the marketing of edible agricultural products, measures for the administration of complaints and reports on food and drugs, measures for the administration of registration and filing of health food, measures for the administration of daily supervision and inspection of food production and operation, measures for the Administration of registration of formula food for special medical purposes, code for the quality management of clinical trials of medical devices, and production of infant formula milk powder were issued There are 9 regulations, such as administrative measures for product formula registration, measures for investigation and punishment of illegal acts of online food safety, decision of the State Food and Drug Administration on Revising the "quality management specifications for drug distribution" Since the establishment of the State Administration of food and drug administration, 33 rules and regulations have been formulated and revised, and the supporting rules and regulations system for food and drug supervision has been improved day by day Sixthly, we should strengthen the examination and clearance of normative documents It has cleaned up nearly 300 normative documents since the establishment of the General Administration, put forward handling opinions on reservation, abolition and invalidation, and solicited opinions from the public At present, the first batch of regulatory documents of food and Drug Administration (2013-2015) has been cleaned up, and the announcement on the cleaning results of the first batch of regulatory documents has been issued, with 22 regulatory documents repealed or invalid The seventh is to promote the revision of the judicial interpretation of "two highs" In order to severely punish the data counterfeiting in the registration process of drugs and medical devices, actively promote the "two highs" research and draft the "interpretation on several issues of applicable laws in dealing with criminal cases of drug and medical device registration application data counterfeiting" At the same time, actively coordinate the "two highs" to speed up the revision of the "interpretation on the application of laws in handling criminal cases against food safety" and "provisions on the application of laws in hearing food and drug disputes" 3、 To deepen the reform of administrative examination and approval system, first, we need to strengthen the cancellation and decentralization of administrative examination and approval The three items of administrative licenses to be cancelled by the central government designated by the State Council submitted by the general administration to the examination and Reform Office of the State Council include the registration and approval of pharmaceutical excipients (excluding new pharmaceutical excipients and imported pharmaceutical excipients) implemented by the food and Drug Administration of the province (district or City), the approval of internet pharmaceutical trading service enterprises (excluding the third-party platform), the preliminary qualification verification of drug clinical trial institutions, and the The Council has issued a cancellation The State Council's review and reform office and the expert demonstration meeting have passed the three administrative examination and approval items submitted by the general administration to the State Council's review and Reform Office, which are to cancel the accreditation of drug clinical trial institutions, the accreditation of medical device clinical trial institutions and the approval of Internet drug trading service enterprises (third-party platforms) Among them, the recently released decision of the State Council on Amending the regulations on the supervision and administration of medical devices changed the accreditation of clinical trial institutions of medical devices to record management Second, we should actively promote the integration of the two syndromes According to the requirements of the newly revised food safety law of the people's Republic of China, the State Administration of food industry and Commerce has reissued the measures for the administration of food business license, merging the two licenses of the original food circulation license and catering service license into one license of food business license At the same time, the notice of the State Administration of food and Drug Administration and the state health and Family Planning Commission on the integration and adjustment of the health license and food business license of public places in catering service places (sfjzzjj-2 [2016] No 29) was issued jointly with the state health and Family Planning Commission, and the health license of four types of catering service places, such as restaurants, coffee, bars and teahouses, was cancelled It is included in the review standard of food business license; issued the Circular of the food and Drug Administration on food hygiene license and food business license after the integration of food and beverage service places, adjusting food business license conditions related matters (food and drug hygiene supervision two [2016] 109), and further streamlined the approval process and conditions Up to now, the General Administration has cancelled, decentralized and adjusted 11 items and 5 items of administrative examination and approval, 24 items of administrative examination and approval and 41 items of local administrative examination and approval Third, standardize the review and approval procedures In order to implement the requirements of the opinions of the State Council on the reform of the review and approval system for pharmaceutical and medical devices (GF [2015] No 44), the General Administration has successively issued nearly 30 reform supporting measures, such as the pilot of drug listing license holder system, the verification of drug clinical trial data, and the evaluation of the quality and efficacy of generic drugs, to further simplify the review and approval procedures and improve the review The examination and approval efficiency and various reform tasks were effectively and orderly promoted Fourth, strengthen the supervision during and after the event Formulate the opinions of the food and Drug Administration on strengthening the in-process and post supervision of the cancellation and decentralization of administrative examination and approval matters, clarify the specific requirements for the decentralization and undertaking of administrative examination and approval matters, and require the food and drug supervision system to adhere to the combination of decentralization and management, strengthen the in-process and post supervision, and earnestly implement the responsibilities of all parties in the reform of administrative examination and approval The notice of the General Administration of food and Drug Administration of the people's Republic of China on further improving the random inspection of food and drug safety and strengthening the supervision during and after the event was issued to implement the requirements of "double random and one open" for the supervision and law enforcement of food and drug Fifth, we should vigorously promote the list of powers The "list of powers" shall be published in a timely manner, and the establishment basis, approval object, approval department, charging basis and standard of administrative approval items shall be publicized to the public on the compilation website of the central authority and the website of the general administration At the same time, in accordance with the requirements of the office of examination and reform of the State Council, the guidelines and detailed rules for examination and approval of the administrative examination and approval matters of the General Administration shall be formulated, setting basis, application conditions, application materials, basic process, time limit for examination and approval and charging basis shall be listed, and the model text shall be made public in a prominent position on the website and acceptance site, and submitted to the office of examination and reform of the State Council for examination and publication 4、 One is to improve the mechanism of administrative decision-making according to law In order to ensure the scientific, democratic and rule of law of administrative decision-making, the General Administration has determined expert argumentation, technical consultation, risk assessment, legitimacy review and collective discussion as necessary procedures for making major administrative decisions It emphasizes the internal legitimacy review mechanism of major decision-making, and each regulatory department shall review the legality of the proposed major administrative decision-making In order to improve the level of scientific decision-making, the measures for the administration of external experts of the State Food and Drug Administration (for Trial Implementation), the measures for the administration of the expert database for the registration and evaluation of formula food for special medical purposes of the State Food and Drug Administration (for Trial Implementation), and the measures for the administration of the Advisory Committee of experts for the registration and evaluation of drugs (for Trial Implementation) have been promulgated to give full play to the external experts in the review and approval Key role in daily supervision Second, we will steadily promote the work of legal advisers Establish a team of legal advisers and experts, and issue the administrative measures for legal advisers of the State Food and drug administration Through strict recommendation and selection procedures, the General Administration has hired 14 well-known experts and lawyers from the academic and practical circles to serve as the legal advisers of the General Administration, forming a legal advisory group of the general administration The advisory group gathered senior legal experts from administrative law, jurisprudence, civil law, criminal law and legal practice to escort food and drug science and legal supervision At the same time, according to the work needs of each department and bureau and the professional background of legal counsel, establish a mechanism for legal counsel to contact with each department and bureau, and provide 2-3 legal advisers for each business department and bureau of the general administration In case of any legal matter to be solved, each business department or bureau may contact the legal consultant at any time for legal assistance The State Administration attaches great importance to the role of "think tank" and "external brain" of legal advisers, actively employs legal advisers to participate in the work of legislation, major administrative decision-making, emergency handling, public reply of government information and response to administrative reconsideration, carries out legal risk assessment, listens to the opinions and suggestions of legal experts, and ensures that all administrative acts of the State Administration are carried out in accordance with the law and procedures, and is practical Safeguard the interests of all parties, effectively reduce the contradictions caused by supervision and resolve legal risks Third, actively promote the system of public lawyers Business with the Ministry of justice, printing and distributing the work plan of national food and drug regulatory system for public lawyers, and holding the post of public lawyers for food and drug regulation
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