Implementing the "Four Strict" to Ensure Food and Drug Safety -- Looking Back on Food and Drug Supervision in 2016

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Editor's note:Another year of inventory. Looking back at 2016, the cadres and workers of the whole system have overcome difficulties and made progress in stability, and have gone through an important milestone in food and drug supervision and development. From the key words such as "four strictest", "four have two responsibilities" and "random shots" from the grass-roots level, we read out the hard work and the pride of harvest. Looking forward to 2017, we, Do not forget your initiative mind, continue to move forward and usher in a new journey of both challenges and opportunities. From the entrustment of General Secretary Xi Jinping and Premier Li Keqiang, we feel greater responsibility and responsibility.

In 2016, the whole system will pursue excellence with rigor, gain trust with professionalism, and live up to expectations with responsibility. On the new regulatory road, let's go hand in hand and forge ahead!

General Secretary Xi Jinping has repeatedly given important instructions on food and drug safety

In January 2016, General Secretary Xi Jinping gave important instructions on food safety work. It is necessary to firmly establish a people-centered development concept, adhere to the same responsibility of the party and government, address both the symptoms and the root causes, strengthen overall coordination, and accelerate the improvement of a unified and authoritative regulatory system and system. Implement the "four most stringent" requirements and effectively guarantee the "safety on the tip of the tongue" of the people ".

In December 2016, at the fourteenth meeting of the Central Financial and Economic Leading Group, General Secretary Xi Jinping clearly stated that strengthening food safety supervision is related to the "safety on the tip of the tongue" of more than 1.3 billion people across the country, and to the health and safety of the people. Party committees and governments at all levels should take it as a major political task. We must adhere to strict prevention at the source, strict process management, and strict risk control, improve the food and drug safety supervision system, and strengthen unity and authority. To meet the general demand, to promote the catering industry to improve the quality of safety.

In December 2016, at the 31st meeting of the leading Group for comprehensively deepening Reform, General Secretary Xi Jinping stressed that to reform and improve the policy on the production, circulation and use of drugs, it is necessary to strictly enforce the examination and approval system for drug listing, speed up the evaluation of drug quality and efficacy consistency, promote the pilot system of drug marketing license holders in an orderly manner, and strengthen the supervision of drug production quality and safety.

Premier Li Keqiang made many important instructions on food and drug safety

In January 2016, Premier Li Keqiang issued instructions on food safety work, pointing out that governments at all levels should adhere to the supremacy of the interests of the people, give full play to the unified leadership and comprehensive coordination role of the Food Safety Commission, firmly implement the food safety strategy with the spirit of reform and the thinking of the rule of law, speed up and improve the authoritative supervision system from the central to the local level to the grass-roots level, and implement the strictest supervision system, zero tolerance for violations of laws and regulations, quick hands, and heavy punches to effectively protect the health and safety of the people.

In February 2016, Li Keqiang presided over an executive meeting of the State Council to deploy and promote the innovation and upgrading of the pharmaceutical industry to better serve the people's livelihood and steady growth; determine measures to further promote the development of traditional Chinese medicine and give full play to the advantages of traditional medicine to benefit the people. The meeting determined that the first is to aim at the urgent needs of the masses and strengthen the research and development and innovation of original research drugs, first imitation drugs, traditional Chinese medicine, new preparations, and high-end medical devices. Two is to improve the safety evaluation and product traceability system, the implementation of drugs, medical equipment standards to improve action. The third is to combine the reform of medical care, medical insurance and medicine linkage to speed up the review and approval of clinically urgently needed drugs and medical device products. The fourth is to build a modern pharmaceutical circulation network throughout urban and rural areas, and gradually straighten out the prices of pharmaceutical consumables.

The government work report in March 2016 emphasized the deepening of the reform of the review and approval system for drugs and medical devices. For the health of the people, it is necessary to speed up the improvement of a unified and authoritative food and drug safety supervision system, strictly observe every line of defense from farmland to dining table, from enterprises to hospitals, so that the people can rest assured of the safety of diet and medication.

NPC Law Enforcement Inspections Lock Food Safety

In April 2016, when the newly revised "Food Safety Law" was implemented for half a year, the Standing Committee of the National People's Congress established a food safety law enforcement inspection team and went to 10 provinces to carry out law enforcement inspections. On June 30, 2016, the 21st meeting of the Standing Committee of the 12th National People's Congress held the third plenary meeting. Chairman Zhang Dejiang attended the meeting and made a report on the inspection of the implementation of the Food Safety Law by the Law Enforcement Inspection Team of the Standing Committee of the National People's Congress. On December 23, 2016, the twenty-fifth meeting of the Standing Committee of the Twelfth National People's Congress was held. Bi Jingquan, director of the State Food and Drug Administration, was entrusted by the State Council to make a report to the Standing Committee of the National People's Congress on the study and handling of food safety law enforcement. Feedback report on inspection report and deliberation opinions.

CPPCC Biweekly Symposium on Food Safety Supervision System

On November 24, 2016, the National Committee of the Chinese People's Political Consultative Conference held the 59th bi-weekly consultation forum in Beijing, focusing on "accelerating the construction of a food safety supervision system. Yu Zhengsheng, chairman of the CPPCC National Committee, presided over the meeting and delivered a speech.

The members believe that food safety is a major basic livelihood issue. First, we must attach great importance to food safety supervision. Food safety is the public safety issue that the people are most concerned about at present, and governments at all levels must attach great importance to it and place it in an important position. Second, establish the authority of the law. Three to improve food safety standards. Fourth, we must strengthen the construction of food safety supervision team. Fifth, we must straighten out the regulatory system.

The national "Shuangan Shuangchuang" enthusiasm is high

In October 2016, the Food Safety Commission of the State Council held a "Shuangan Shuangchuang" on-site meeting in Chengdu. On December 14, 2016, the National Food Safety Demonstration City Creation Promotion Conference was held in Yichang City, Hubei Province. The pilot areas have been expanded to 67 cities and 107 counties (cities) in 31 provinces (autonomous regions and municipalities) across the country, covering all provincial capitals and cities under separate state planning, and covering the 0.43 billion population. The enthusiasm for creation in various regions is high. The first two batches of pilot cities have greatly improved their food safety assurance capabilities compared with those before creation. Supervisors, work funds, law enforcement vehicles, law enforcement equipment, and inspections have all increased significantly.

Improve the system of regulations and standards, and speed up the construction of the rule of law.

In 2016, the State Council revised and promulgated the regulations on the Administration of Vaccine Circulation and vaccination; the regulations on the implementation of the Food Safety Law and the regulations on the Supervision and Administration of Cosmetics have been submitted to the State Council for deliberation; and the Drug Administration Law is being revised as planned. Promulgated and promulgated 9 departmental regulations including the "Administrative Measures for the Registration and Filing of Health Food", "Measures for the Investigation and Punishment of Online Food Safety Violations", and "Pharmaceutical Business Quality Management Standards (Amendment). To strengthen the guidance of local legislation, a total of 16 provinces have issued local laws and regulations on small workshops and food vendors.

In conjunction with the China Railway Corporation, the "Railway Operation Food Safety Management Measures" was issued to clarify the scope of railway food safety management and strengthen railway operation food safety management. Issued the "Implementation Opinions on Comprehensively Strengthening the Rule of Law Construction of the Food and Drug Regulatory System" to establish the overall goal of the rule of law construction throughout the system; issued the "Seventh Five-Year Plan for the Publicity and Education of the Rule of Law in the National Food and Drug Regulatory System (2016-2020)", The publicity and education of the rule of law has been fully deployed.

Food and drug safety "13th Five-Year" curtain opened

In the outline of the 13th five-year Plan for National Economic and Social Development released in March 2016, the goals and plans of "healthy China" during the 13th five-year Plan period were set in terms of ensuring food and drug safety and comprehensively deepening the reform of the medical and health system.

In September 2016, the State Council issued the "Thirteenth Five-Year" National Science and Technology Innovation Plan, which clarified that the content of food and drug safety should be included in the "Thirteenth Five-Year" National Science and Technology Innovation Plan, and pointed out the goals and goals for the next five years of food and drug safety technology innovation. direction.

The General Administration issued the guidance on strengthening the Network Security and Informatization Construction of Food and Drug Supervision during the 13th five-year Plan period to guide and promote food and drug regulatory departments at all levels to use information means to improve regulatory efficiency and service efficiency, and move towards intelligent supervision. It is reported that the "13th Five-Year" National Food Safety Plan and the "13th Five-Year" National Drug Safety Plan will be released in the near future.

Food safety governance more in-depth

In the field of food production, special inspections and unannounced inspections are carried out to address the problems of key varieties of agricultural and veterinary drug residues, illegal additions, and the use of food additives beyond the scope and limit. Supervise and urge large food production enterprises to implement the main responsibility and play a leading role in demonstration.

For special foods such as infant formula foods, more stringent pre-market product registration and approval will be implemented, focusing on combating illegal additions and functional claims of health foods. Organize full coverage inspections of 795 dairy products companies, and conduct standardized system inspections of 22 infant formula milk powder manufacturers. Standardize the Internet food business, deployment in the north and other places to carry out the network ordering special rectification.

A total of 1.293 million batches of samples were completed nationwide, covering 33 major food categories, 200 food sub-categories, 133000 production enterprises, 431 safety index items, and various formats such as domestic and import, entity and online sales. The development of food sampling information mobile phone query client APP has seen 3 million times since its launch. Formulate the "List of Risk Varieties and Items of Edible Agricultural Products", implement the tabular, standardized, quantitative and standardized inspection of inspection items, implement the "double random" requirements, and improve the efficiency of supervision.

Drug review and approval reform dividend release

Since the implementation of the "Opinions of the State Council on Reforming the Review and Approval System for Drugs and Medical Devices" in August 2015, drug review and approval has been continuously accelerated, reforms have stimulated the innovation vitality of enterprises, and reform dividends have been continuously released. By the end of December, the number of drug registration applications waiting for review had been reduced from 22000 at the peak of the backlog in 2015 to about 8000. The backlog of drug registration applications has been effectively alleviated and is expected to be reviewed according to the time limit by the end of 2018. A total of 10086 technical reviews of medical devices were completed, an increase of 19% over the same period last year. At present, 46 drugs from 40 companies have been declared according to the new registration classification, of which Class 1 new drugs account for half of the country. According to the "Special Approval Procedure for Innovative Medical Devices", 88 products have entered the special approval channel for innovative medical devices, and 20 innovative products have been approved for listing.

The Drug Review Center accelerates the construction of the reviewer team. The establishment was adjusted from 120 to 190. Since 2016, large-scale talent recruitment has been launched, the talent development model has been innovated, the enthusiasm of review staff has been stimulated, performance evaluation and post setting management have been increased, and the establishment of a reasonable salary and treatment system for review staff has been explored. By the end of 2016, the number of staff has increased to nearly 600. In addition, Dr. He Ruyi, FDA, was introduced as the chief scientist to promote the construction of high-quality and high-level review scientists.

Marketing licence holder pilot blossoms and bears fruit

At the end of December 2016, the new anti-tumor drug gefitinib API developed by Qilu Pharmaceutical in Shandong Province was approved, becoming the first pilot variety of drug marketing license holder system in China. With the pilot work carried out in 10 provinces (cities) of Beijing, Tianjin, Hebei, Shanghai, Jiangsu, Zhejiang, Fujian, Shandong, Guangdong and Sichuan, the policy is of great significance for encouraging drug innovation and improving drug quality.

Generic drug consistency evaluation ice-breaking forward.

The General Administration has set up a consistency evaluation office, established an expert committee composed of 66 domestic authoritative experts, opened a column on the official website, and published 10 consistency evaluation related working documents and 5 technical guidelines. The General Administration hosted a total of 9 "National Generic Drug Quality and Efficacy Consistency Evaluation Training Course", with more than 10,000 participants. As of December 20, 2016, the General Administration has received a total of 4163 filings of consistency evaluation reference preparations and 2272 filings of 289 varieties.

At the 4th China-ASEAN Pharmaceutical Cooperation and Development Summit Forum and the Western Pacific Region Herbal Medicine Coordination Forum, focusing on the topic of "improving the quality of generic drugs", countries shared the experience of generic drug quality supervision, and established and improved the international cooperation and coordination of generic drug quality and efficacy consistency evaluation mechanism.

28 departments jointly punish food and drug serious dishonesty

In September 2016, 28 departments, including the National Development and Reform Commission and the Food and Drug Administration, reached a memorandum of cooperation to carry out joint punishment on those who seriously break their promises in the production and operation of food and drugs, which is of great significance for speeding up the construction of a credit system in the field of food and drugs and establishing and improving a joint punishment mechanism for dishonesty.

Recently, the food and drug regulatory authorities regularly provide information on the list of serious dishonest persons in food and drug production and operation to the departments participating in the joint punishment of dishonesty through the national credit information sharing platform, local credit information sharing platform and other information technology means. The serious breach of faith to carry out joint punishment, so that the breach of faith "one place, everywhere under control".

Flight Inspection Normalization Force Breaks Hidden Rules

In 2016, the General Administration implemented the "double random" requirement, stepped up flight inspections, inspected 45 drug manufacturers and recovered 25 drug GMP certificates. Flight inspection of 51 medical device manufacturers, ordered to suspend production for rectification of 8; For the first time, flight inspection was carried out on 15 medical device business enterprises and 19 overseas production enterprises were inspected. We will comprehensively crack down on illegal business activities in the field of drug and medical device circulation, put on record 1345 pharmaceutical enterprises, revoke or cancel 241 "drug business licenses", and cancel or revoke 4562 medical device enterprise licenses. In-depth crackdown on clinical data fraud, organization to carry out 12 batches of on-site verification, clean up the industry atmosphere. Organize and carry out special rectification of biochemical drugs, Chinese herbal pieces, and bezoar, and take measures such as suspension of production and business for rectification and rectification within a time limit for 48 enterprises.

Heavy blow to medical device violations

Since 2016, the General Administration has organized supervision and spot checks on the authenticity and compliance of clinical trial data of 20 registration application projects, found that there were problems with the authenticity of clinical trials of 8 registration application projects, and made a decision not to register.

The General Administration requires all enterprises engaged in the second and third types of medical device operations to conduct self-examination of 8 illegal acts. Subsequently, the General Administration organized 15 inspection teams to cross-check the rectification of illegal business activities in the field of medical device circulation and medical device business enterprises in 31 provinces (autonomous regions and municipalities) across the country. This is the first national cross-examination in the field of medical device circulation organized by the General Administration.

Drug Inspectors Go Professional

The inspector is the representative of the public interest, the exerciser of the public power of the state, and the watcher of the people's health. On December 29, 2016, the General Administration held the certification and swearing-in ceremony for the first newly appointed national drug inspector in Beijing. There are 649 new national drug inspectors, including 108 international inspectors. As of November 2016, the General Administration has trained 120 national medical device inspectors and issued the national medical device inspector certificate to the first batch of 35 qualified people.

The General Administration is studying the establishment of a professional team of inspectors to make inspectors a promising, promising and promising profession.

Information Disclosure Promotes Effective Supervision

Information disclosure can protect consumers, restrain law enforcers, deter lawbreakers, strengthen supervision by public opinion, and promote the construction of a credit system. In 2016, the General Administration announced the results of a total of 22462 batches of food sampling in 49 phases, exposing illegal enterprises. The General Administration adheres to the synchronization of information disclosure and policy interpretation, conducts timely publicity and interpretation around major regulatory policies and social hot issues, responds to social concerns, and holds 12 press conferences and briefings. The official micro-signal and headline number of "China Food News" were launched, with 2.3 million views in 2016.

News propaganda transfer positive energy

In 2016, the "National Food Safety Publicity Week", "National Safe Drug Use Month" and "Food and Drug Complaint Reporting 3.31 Theme Publicity Day" publicity activities were held, covering 0.43 billion people.

In November 2016, China Health Media Group Co., Ltd. was officially established. The group is established on the basis of China Pharmaceutical Newspaper and China Pharmaceutical Science and Technology Press. The future development of the group will focus on paper media, digital media, display media and other fields.

2016 "food and drug safety watchman" activity deeply excavated the touching deeds of a large number of food and drug safety workers, and finally produced 20 "food and drug safety watchman" pioneers, 30 elegant demeanor figures and 108 representative figures, transmitting the positive energy of food and drug supervision.

Carrying out "Two Studies and One Doing" to Strengthen Party Building Work

In 2016, the General Administration promoted the "two studies and one doing" learning and education, held a mobilization and deployment meeting, held a "two studies and one doing" learning and education off-the-job training class, and carried out 8 party group theory center group studies. The main responsible comrades took the lead in teaching party classes. Deeply study, publicize and implement the spirit of the Sixth Plenary Session of the 18th CPC Central Committee.

Actively cooperate with the central inspection team for special inspections, hold a special democratic life meeting of the party group, formulate rectification implementation plans, and strengthen supervision and inspection. Four inspection teams have been sent to inspect 18 units directly under the General Administration in two rounds to achieve full coverage and no dead ends.

In addition, it has also strengthened the guidance and contact of the discipline inspection work stationed by the food and drug regulatory system, enhanced the ability to supervise and enforce discipline and accountability after comprehensive stationing, and urged the provincial food and drug administrations to implement the task of building a clean and honest government. By holding the fourth work meeting of the General Administration on the building of party style and clean government, signing a letter of responsibility for party style and clean government, strengthening the "double responsibility of one post," and timely reporting cases of violations of law and discipline, so that party members and cadres can be disciplined, abide by the bottom line, and continue to oppose the "four winds".

Through the establishment of the Office of the Disciplinary Committee of the agency, the General Administration urged the directly affiliated party organizations to strengthen the construction of discipline inspection organizations, and strengthened the grassroots party organizations to implement the main responsibility of comprehensively and strictly governing the party.

Administrative counterpart as of the end of November 2016

1. food

There are 165918 food production licenses and 3480 food additive production licenses nationwide; there are 136233 food production enterprises and 3329 food additive production enterprises.

There were 2328 health food production licenses nationwide, a year-on-year decrease of 4.6 percent.

There are 12338782 food business licenses nationwide, including 8626330 for food sales, 3200790 for catering services and 511662 for unit canteens.