Director of Food and Drug Administration Yin Li: Protecting against major food safety accidents

Director of Food and Drug Administration Yin Li: Protecting against major food safety accidents Guest Profile:

Yin Li, male, was born in Jinan City, Shandong Province in August 1962. He joined the Communist Party of China in June 1983 and has a master's degree in medical science. In February 2012, he served as Secretary of the State Food and Drug Administration and Party Secretary.

The 18th CPC National Congress clearly put forward the tasks and requirements for strengthening social construction in the improvement of people's livelihood and innovation management, and stressed the need to focus on advancing the comprehensive reform of drug supply and supervision systems, and reforming and improving the food and drug safety supervision system and mechanism. After the victory of the 18th National Party Congress, the director of the State Food and Drug Administration, Yin Li, accepted an interview with CCTV reporters on how to implement the spirit of the 18th National Congress and how to further strengthen food and drug supervision during the 12th Five-Year Plan period. The following is an interview record:

Implementing the spirit of the 18th National Congress To do a good job in the current food and drug supervision work CCTV: The report of the 18th National Congress of the People's Republic of China put forward the tasks and requirements for strengthening social construction in improving people's livelihood and innovation management. It emphasized that we must focus on promoting the comprehensive reform of drug supply and supervision systems. How should food and drug supervision authorities implement the spirit of the 18th National Congress and what learning and communication activities will be carried out?

Yin Li: After the victory of the party's 18th National Party Congress, the State Food and Drug Administration organized, in a planned and planned manner, the work of learning, publicizing, and implementing the spirit of the Eighteenth National Congress.

First, grasp communication and learning. During the Eighteenth National Congress of the Communist Party of China, the staff members and workers of all party members of the State Food and Drug Administration organization department and their directly affiliated organizations listened and listened. On the afternoon of November 14th, the closing of the conference, the Party Group of the State Food and Drug Administration convened the party group expansion meeting to convey the grand occasion and spirit of the meeting, and study, deploy, study and implement opinions. On November 16, the State Food and Drug Administration convened a meeting of party members and cadres at or directly under the bureau to conduct comprehensive communication and learning.

Second, grasp the mobilization and deployment. In accordance with the arrangements and deployment of the first meeting of the new Politburo and the working committee of the Central State Organs, combined with the reality of food and drug supervision, on November 17, the party group of the State Food and Drug Administration issued the “On the study and implementation of the Party. The "Implementation Opinions of the 18th National Congress" requires the close integration of the work and the implementation of the spirit of the 18th Party Congress.

Third, grasp the work seminar. In recent days, the main responsible comrades of the State Food and Drug Administration organization organs and their direct affiliates convened workshops focusing on food and drug safety issues that are currently concerned by the people, on how to strengthen food and drug supervision, improve work methods, and change work. The style of work conducts in-depth studies to further clarify current and future working ideas.

Fourth, we must take concrete steps to implement it. The State Food and Drug Administration clearly stated that it is necessary to use the Party’s 18 spirit to arm its mind, guide practice, and promote supervision; it is necessary to regard improvement of food and drug supervision as an important criterion for studying and implementing results; it is necessary to stand at the height of ensuring people’s health and be positive. Promote the reform of food and drug regulatory safety systems and mechanisms, build a food and drug supervision team that meets the requirements of the times, and comprehensively improve the level of food and drug supervision. In view of the reality of the national food and drug regulatory system, the State Food and Drug Administration has vigorously promoted the development of party organizations of learning, service, innovative, open, and exemplary organizations, and strived to reinforce the ideological and organizational basis for promoting supervision.

Improve the level of food and drug supervision should strive to transform the industry chain into a chain of responsibility CCTV: The Party’s report to the 18th Congress proposed that we must emancipate our minds and strive to implement the spirit of reform and innovation throughout all aspects of governing the country. In the field of food and drug supervision, how can we use the ideas of reform and innovation to comprehensively raise the level of supervision to meet the people's new needs and expectations for food and drug safety?

Yin Li: The food and drug supervision department is mainly responsible for the supervision and administration of food safety in medicines, medical devices, health foods, cosmetics, and catering services. In recent years, the issue of food and drug safety has received more and more attention from the people. The people have not only satisfied with “have” but with “good”. Now it must be able to “have better” on the basis of “guaranteeed”. The food and drug industry chain is long and there are many benefits, and there are many factors that can cause risks.

At present, the most important thing is to work hard to transform the industrial chain into a responsibility chain, to detect and eliminate risks in a timely manner, so that each interest can truly assume its responsibilities. The realization of this transformation work not only requires us to innovate in the concept of supervision and regulation, but also more importantly, to innovate in the design of the system. We must adopt institutional innovation to form a complete chain of product quality and responsible subjects, and form an industrial chain. The inseparable link between benefits and responsibilities, to ensure product quality and safety has become a conscious behavior of each link. This is the fundamental solution to the problem of food and drug supervision in China, and it is also the key to comprehensively improving the level of government supervision.

Under the guidance of the spirit of the 18th National Congress of the CPC, the food and drug supervision system will focus on deepening the overall situation of medical reform and focus on the implementation of the 12th Five-Year Plan for National Drug Safety, and do a good job in four areas:

The first is to work hard to solve the hot and difficult issues people are concerned about. Combine relevant parties to severely crack down on the use of the Internet for the production and sale of counterfeit medicines, illegal addition of chemical drugs to health foods, food and beverages indiscriminate use of food additives, and other violations of laws and regulations, and crack down on publishing illegal drugs, Medical Equipment, health food advertising. Collaborate with public search engines to provide the public with a platform for accessing authoritative and authentic drug safety information.

The second is to strive to promote the quality of production and management of enterprises. We will promote the implementation of the newly revised "Code for the Quality Control of Pharmaceutical Production" and the new revision of the "Standards for the Quality Management of Pharmaceutical Operations" to comprehensively improve the quality of pharmaceutical production and operation. Promote the implementation of the “Medical Device Manufacturing Quality Management Practice” to ensure that all manufacturers of aseptic and implantable devices implement 100% regulatory requirements.

The third is to improve the regulatory system of laws and regulations. Actively promote the newly revised Regulations on the Supervision and Administration of Medical Devices, the Regulations on the Supervision and Administration of Health Food, and the revision of the Drug Administration Law to consolidate the legal and regulatory basis for food and drug supervision.

Fourth, efforts will be made to upgrade the construction of a regulatory support system. Promote the improvement of national drug standards and national medical device standards, and improve the level of quality control and safety protection. Improve inspection and detection capabilities, and rationally plan national, provincial, and municipal levels of inspection and inspection equipment and tasks to improve grassroots rapid screening and mobility capabilities.

Focusing on Promoting Medical Reform to Ensure the Quality and Safety of Essential Drugs CCTV: Basic drug quality and safety are related to the overall situation of the reform of the medical and health system. What measures have the State Food and Drug Administration adopted in recent years in guaranteeing the quality and safety of essential drugs? What is the current situation of the quality and safety of essential medicines in China? What are the next steps?

Yin Li: The food and drug supervision system conscientiously implemented the work plan of the CPC Central Committee and the State Council to deepen the reform of the medical and health system and fully safeguarded the quality and safety of essential medicines. It mainly carried out work in five areas:

The first is to improve the basic drug quality standards. Revised and promulgated 197 new standards for essential drugs, so that the quality standards of 307 drugs included in the National Essential Drug List are all in compliance with the Chinese Pharmacopoeia. The second is to strengthen supervision of key links. The company completed the process and prescription verification of 17,790 essential drug varieties and specifications. Examine basic drug distribution companies for full coverage. The third is to strengthen monitoring of adverse drug reactions. In all 333 administrative regions of the country, all monitoring agencies have been set up or assigned special personnel to monitor the work. The fourth is to implement full-species coverage testing for essential drugs. The fifth is the implementation of full electronic surveillance of essential drugs. In recent years, the passing rate of basic drug testing in our country has reached more than 98%, and the quality of essential drugs can be assured to the public.

In the next stage, we will do the following in accordance with the relevant requirements of the 18th National Congress of the People's Republic of China on advancing medical reform: First, we will strictly examine and approve basic medicines for market approval, and we will make good access to them; Second, we will carry out evaluation on the consistency of basic drug quality and promote the quality of essential drugs. To achieve international standards; Third is to strengthen process supervision, strict basic drug research, production, circulation, use, price and advertising supervision; Fourth, based on the basic drug full-species coverage testing, and further increase the supervision and inspection of key varieties Regular announcement of quality announcements; Fifth, investigate and punish unqualified production enterprises according to law, standardize the circulation order, and severely crack down on the production and sale of fake and shoddy drugs.

The electronic monitoring of all drugs will be implemented at the end of the “Twelfth Five-Year Plan” period. CCTV: In the Twelfth Five-Year Plan for National Drug Safety, it has specifically requested informationization and requested the State Food and Drug Administration to take the lead in advancing drug e-regulation. System construction, how is the current progress? What is the significance of implementing electronic regulation for the public?

Yin Li: Simply put, drug and electronic supervision is a code for each box of drugs, that is, drug "identity card", to monitor the whole process of production, circulation and use of drugs. The State Food and Drug Administration began implementing this work in 2006. By the end of February this year, it has included e-narcotics, psychotropic substances, blood products, Chinese medicine injections, vaccines, and essential drugs in electronic surveillance in three phases. At present, we are expanding the coverage of electronic drug supervision, extending from production and distribution to use, and extending to retail pharmacies and medical institutions. At the end of the “Twelfth Five-Year Plan” period, electronic supervision of all drugs was completed.

The implementation of drug electronic regulation is of great significance. The first is to help effectively crack down on the production and sale of counterfeit and inferior drugs. The drug electronic regulatory network has implemented closed-loop operations, and illegal drugs cannot enter the country's regular sales and use channels, which can protect public drug safety. The second is to help trace recall products. When a phytotoxicity incident occurs, the network can trace and recall problematic products in the shortest time and at the fastest speed. Third, the public can use this system to promptly inquire about the real information of drugs. At present, for drugs that have been incorporated into electronic surveillance, after the public purchases, the real information of the drugs they purchase can be queried by telephone, SMS, and internet.

The four major measures started to crack down on the production and sale of counterfeit and inferior drugs. CCTV: It is understood that in recent years, the food and drug supervision system has repeatedly carried out special drug safety rectification, but drug safety incidents still occur from time to time. How do we judge the previous drug safety special rectification? The effect of the action? What are the new situations and problems faced in cracking down on counterfeit drugs? What are the new initiatives?

Yin Li: The Party Central Committee and the State Council attach great importance to drug safety and have deployed many times to carry out special drug safety rectification work. The food and drug regulatory authorities at all levels, in accordance with the unified arrangements, gave full play to the role of the 13 departments in cracking down on the inter-ministerial coordination meeting for production and sales of counterfeit medicines, and adopted the methods of rectifying and regulating both concurrent, temporary, and permanent cures, and achieved very good results. Through rectification, the supervision and management of pharmaceutical production, production, circulation, and use have been more standardized. The order of production and operation of pharmaceuticals has improved, the momentum of manufacturing and selling of counterfeit and inferior drugs has been contained, and the drug safety situation has generally remained stable and steady.

In the counterfeiting of pharmaceuticals, we have indeed faced some difficulties. First, the current case of counterfeit drugs for manufacturing and selling has become increasingly high-tech, collectivized, and concealed. Criminal criminals have used black nest production, used false Internet propaganda, and sent fake drugs through postal channels. There are many ways to commit crimes. Second, in some areas, the market for medicinal herbs and rural pharmacies are the worst-hit areas for counterfeit medicines, and the supervision of grass-roots drugs needs to be strengthened. Third, there is not enough shocking law, and the convergence between administrative law and criminal law has yet to be improved.

The next phase will focus on four aspects: First, give full play to the inter-ministerial coordination and joint conference system, build a multi-sectoral, trans-regional, all-round joint anti-counterfeiting mechanism, improve laws and regulations, and jointly develop counterfeit drugs with the public security authorities. The black den, the use of the Internet to counterfeit the sale of counterfeit drugs. The combination of case investigation and information reporting, information sharing, linking up with execution, case transfer, etc. forms a joint force against counterfeit drugs. Second, improve the supervision system for major cases and cases, supervise the handling of a large number of major cases with strong social influence and strong public reactions, and shocked the behavior of counterfeiting and sales of drugs. Third, we will combine daily supervision and special actions to further implement the “doubles,” professional markets for Chinese medicinal materials, and rural pharmacy remediation. Combining with key areas and key enterprises exposed in the daily supervision process, targeted supervision and inspection will be carried out. Fourth, increase the degree of participation in drug counterfeiting and social participation, and welcome public complaints and public opinion supervision.

Grasp the key difficulties to ensure that there is no major food safety accident CCTV: Food and Drug Supervision Department is responsible for the food safety of food and beverage links, to ensure food safety in the food chain where the difficulties? What effective work will be carried out next?

Yin Li: Since the State Food and Drug Administration conducted the food safety supervision function for catering services in 2009, it has carried out a series of special rectifications around outstanding problems and weak links in the catering service sector. For example: to organize the launch of crackdowns on the illegal addition and misuse of food additives, waste oil, etc., and to carry out special food safety rectifications in school cafeterias, canteens on construction sites, and food service units in tourist attractions. In the past three years, there have been no major food safety incidents in the food service sector.

At present, there are three main difficulties in ensuring food safety in the food and beverage sector: First, there are many security risk factors, and the food and beverage service link is at the end of the food production and operation chain. There are many kinds of raw materials and there are many procurement channels. The upstream link security risks are easily accumulated in this link. It is difficult to prevent and control security risks. Second, the level of development of the industry is low. The situation is more serious, more or less, scattered, or low. It is difficult to change fundamentally in the short term. Third, the regulatory power is insufficient. Currently, more than 245 catering service units have obtained permits throughout the country. The number of food safety supervision and law enforcement personnel of 10,000 food and beverage services is only 30,000. The lack of supervision power has restricted the effective implementation of supervision work.

The next step will be to focus on four tasks: First, comprehensively carry out food safety risk investigations for food and beverage services, carry out special rectification and comprehensive management, and plug regulatory loopholes; second, promote quantified management of food safety supervision of food and beverage services, and strive for 2013. Completed the first quantitative grading assessment of various catering service units before the end of the month; third, promoted the catering service food safety demonstration project construction, selected and announced the list of national catering service food safety demonstration counties, and continued to promote the catering service food safety one hundred million demonstration project. The construction will lead the healthy development of the catering industry through the lead role of radiation in the demonstration areas. Fourth, it will deepen the education and training of food safety in catering services, strengthen the awareness of food safety agents in catering service units, and increase consumers’ health and scientific concept of eating.

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