Bi Jingquan: strictly check the potential rules of ultra-low price drugs and industries

Source: CFDA / guancanghai 2017-01-06 yesterday (5 days), the website of the State Food and Drug Administration announced Bi Jingquan's speech at the ceremony of issuing certificates and swearing in the newly appointed national drug inspectors The speech emphasized that in addition to the 649 national drug inspectors appointed this time, the State Administration will also implement food inspectors and medical devices Inspector system, and is studying to establish a professional team of inspectors, the remuneration of inspectors should be closely linked with their inspection skills, inspector level, workload, and the implementation of "performance pay" At the same time, bijingquan stressed that it would strengthen the test of drugs with low prices that do not conform to the market rules, and study the methods to break the "hidden rules" such as "false negative" and "other" hidden rules " In fact, in recent years, the State Food and drug administration has continued to strengthen its efforts in drug inspection Public data shows that in 2016, inspection has become one of the "key words" of drug regulation According to the statistical data of the audit and inspection center of the State Administration (hereinafter referred to as the "Audit Center") as of the end of December 2016, a total of 611 enterprises / varieties were inspected and 515 inspection teams were dispatched throughout the year In the GMP follow-up inspection - "double random", 651 non sterile preparation manufacturing enterprises that passed the provincial GMP certification inspection in the first half of 2016 were followed up and 13 enterprises were randomly selected for follow-up inspection In the on-site inspection of drug registration production, 36 on-site inspection reports of drug registration production were completed, including 6 failed varieties In the flight inspection of GMP, 35 enterprises have been inspected throughout the year, 11 enterprises are recommended to withdraw GMP certificate, and 11 enterprises are recommended to be put on file for investigation Among them, 6 Chinese medicine enterprises proposed to withdraw GMP certificates, 2 for investigation, 1 for suspension of production, and 4 for withdrawal of biochemical drugs After the vaccine incident in Shandong Province in 2016, the State Administration launched the drug GSP flight inspection Since October of that year, 41 enterprises in 25 provinces have been flying inspected, and 23 enterprises have been revoked the GSP certificate and the drug business license Attachment: speech by Bi Jingquan at the ceremony of issuing certificate and swearing in the newly appointed national drug inspectors: near the end of the year, we are now issuing inspector certificate and holding swearing in ceremony for newly appointed national drug inspectors First of all, congratulations Let me make three comments 1、 From 2015, we started to prepare for the appointment and renewal of inspectors We have held four training courses for the appointment of national GMP inspectors and one training course for the inspection of blood products, and passed the on-site inspection and assessment This year, we have made two public announcements and appointed 649 national drug inspectors Drug inspection is very important and it's glorious to be an inspector In particular, you can pass the recommendation of the Provincial Bureau, the training and assessment of the General Administration and experience the elimination rate of nearly 50%, which shows that your professional technology is excellent and your business ability is top-notch National inspectors are the highest honor among inspectors, and also the group with the highest and strongest ability of drug inspection in China Drug inspector is not only an honor, but also a responsibility All of them come from the departments and bureaus of the General Administration, the inspection institutions and inspection institutions of all regions, some from the local review institutions, as well as the adverse reactions monitoring institutions, etc But you have a common identity, which is "national drug inspector" When you carry out the inspection task, you represent the image of China food and drug administration, its ability and its level Your responsibility is to ensure the quality of Chinese food and medicine and the health of the people I hope you will keep in mind today's oath, fulfill your duties, fulfill your mission, maintain the image of the inspection team, safeguard the honor of China's food and drug inspection agency, and be loyal guardians of people's health Drug inspectors should dare to adhere to the principle The clinical trials, production process, transportation, storage and sales of drugs are strictly regulated These specifications are our inspection standards The problems found in the inspection must be truthfully recorded, truthfully reflected, scrupulous and selfless We will never let go of any problems that may affect the quality of drugs and the safety and effectiveness of drugs Everyone has an important responsibility in promoting the industry to form an atmosphere of advocating science, respecting science, making medicine with conscience and abiding by laws and disciplines In the inspection of drug registration stage, we should focus on the authenticity, consistency and the feasibility of listing, and strictly control the listing of drugs In the GMP follow-up inspection, it is necessary to ensure the continuous compliance of the production process and the integrity, authenticity and traceability of the data In the inspection of causes, we should dare and be good at exposing "hidden rules" and crack down on illegal behaviors Drug inspectors should be strict with discipline The inspection involves the overall situation of drug supervision The greater the responsibility, the higher and stricter the requirements Inspectors should obey the arrangement and command as soldiers go to the battlefield to perform inspection tasks They should not do their own thing They should strictly follow the GCP, GMP and GSP The inspection responsibilities shall be performed in a standardized way, without water discharge or favoritism; the specified inspection workload shall be completed, new knowledge shall be continuously learned, and the sensitivity to inspection work shall be maintained; the confidentiality discipline shall be strictly observed, and the process secrets and business secrets of the enterprise shall not be disclosed, and the inspection work secrets shall not be disclosed 2、 How to be a qualified inspector first of all, we should be devoted to our duties Inspectors should be "loyal" First, we should be loyal to the party and the people Inspector is the representative of public interest, the executor of state public power and the watchman of people's health Therefore, we must perform our duties in a spirit of high responsibility for the cause of the party and the people Second, be loyal to the law Laws, regulations, rules and regulations, which are the "rules of heaven" that every drug practitioner must strictly abide by, should be respected by the regulators and the regulated Our inspectors are the maintainers and executors of these "tiantiao" Third, we should be loyal to the cause of food and drug supervision Food and drug supervision is a public service and an important part of the public safety system To ensure the quality and safety of food and drug is the sacred duty of our food and drug regulatory department To fulfill this sacred duty, we must rely on our inspectors to strictly enforce the law on the front line If you choose this career and devote yourself to it, you must be loyal to it and to it Second, we should have five abilities One is the ability to judge right and wrong During the inspection, it seems to be relatively easy to judge whether it is illegal or not, but in the first-line inspection, it may be a matter of minutes Every inch of difference is a thousand miles of error We should have the concept of distinguishing right from wrong and the ability to judge right from wrong It needs professional knowledge and courage to judge whether each index is qualified It reflects the ability and quality of inspectors Second, the ability to find problems Food and drug supervision focuses on finding problems and hidden dangers, and whether problems can be found, which is a major test of inspectors' ability Only when problems are found and raised can problems be solved, hidden dangers be eliminated, and the quality and safety of food and drugs be guaranteed Third, the ability to check and handle cases General secretary Xi Jinping called for every case to be punished Our current inspection of administrative law enforcement often focuses on the illegal behaviors of enterprises, but the illegal behaviors are committed by specific people In the future, in the inspection and inspection of food and drugs, the direct responsible person and indirect responsible person shall be responsible for any problems found in violation of laws and regulations Only when the punishment for every illegal act is imposed on natural persons can we be deterred by such inspection and punishment This requires our inspectors to learn to collect evidence, and the inspection records made on the spot should have legal effect in the court Fourth, the ability to study inspection methods At present, our food and drug inspection and inspection have stipulated standards and codes of conduct However, some enterprises and individuals try their best to avoid these standards and norms in order to maximize their interests Check according to the existing standards and specifications It may be qualified, but there are also "false negative" To solve these problems, we need to be good at discovering, dare to expose, and study ways to break these "hidden rules" Rectifying Ginkgo biloba preparation is a good case National inspectors should have the ability to research and develop methods So inspectors should also do scientific research You should have a lot of first-line practical experience and be good at finding clues Fifth, the ability of writing We need a large number of inspectors We hope that the national inspectors will not only be able to do their own work, but also be able to communicate, summarize, write articles, compile textbooks and bring apprentices To write an article, you should have a clear point of view, a rigorous logic, accurate data and concise language You are the seed When you sow it all over the country, you will bring a large number of qualified inspectors to drive the improvement of the whole food and drug inspection capability Third, we should be familiar with four aspects of knowledge First, be familiar with the professional knowledge of food science and drug science In the inspection of food and medicine, we need to know the relevant professional knowledge, what is its composition, what kind of chemical principle and what kind of production process This is the line of inspectors Food and drug inspection is a professional work, there is a threshold, not everyone can do it Second, be familiar with the basic knowledge of law and law We are performing our official duties and representing the power of public power We need to understand the procedures of the law, how to collect illegal evidence, and make the procedures legal and the evidence effective Especially in checking and handling cases, the prosecution and proof should be legal Third, be familiar with the basic knowledge of computer application Check the R & D, production and operation of the enterprise, require the data to be recorded truthfully and timely, and all data shall be traceable and not be tampered with Now enterprises have realized computerized management Inspectors should be familiar with the basic knowledge of computer application Of course, it is better to understand the professional knowledge of computer, which is also an important test of our inspection ability Fourth, have basic knowledge of financial analysis Any illegal act has economic interests and profit-making motives Last year's ginkgo leaf preparation case, a board of 24 ginkgo leaves, the cost can not be less than 1.8 yuan, but some enterprises can actually sell 1.2 yuan, how can we make this medicine without fraud? Some say that the loss of this product depends on the profit of other products, which is also untenable Selling medicine at a price lower than the cost will crush legal and legal enterprises This is unfair competition, an economic crime, and it will damage the public interest Now we should pay special attention to the phenomenon of "virtual low" in addition to the virtual high of drug prices If the price is so low and the product is still qualified, this is the risk we should pay attention to in drug inspection and inspection So we should learn the knowledge of economics and the knowledge of enterprise financial accounting Fourth, to cultivate