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    Home > Medical News > Medical World News > The food and drug supervision and employment of state-level drug inspectors to strictly investigate the counterfeiting of pharmaceutical enterprises

    The food and drug supervision and employment of state-level drug inspectors to strictly investigate the counterfeiting of pharmaceutical enterprises

    • Last Update: 2021-02-08
    • Source: Internet
    • Author: User
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    On December 29, the State Administration of Food and Drug Administration held the first ceremony in Beijing to appoint a new state-level drug inspector to issue certificates and swear. The following is the original speech by Bi Jingquan, Director General of the State Food and Drug Administration.
    :
    is approaching the end of the year, we are today dedicated to the newly appointed state-level drug inspectors issued inspectors' certificates, held the swearing-in ceremony of inspectors. First of all, I would like to congratulate you all. Let me make three comments., expectations for inspectors
    starting in 2015, we began to prepare for the appointment and replacement of inspectors. We have run four national drug GMP inspectors hired training courses and a blood products inspector training courses, and by on-site inspection and examination qualified, this year has been in two batches of external announcements, hired 649 state-level drug inspectors. Drug inspection is important and it is an honor to be an inspector. In particular, we can pass the recommendation of the provincial bureau, the General Administration of training and assessment, experience nearly 50% of the elimination rate, indicating that everyone's professional and technical skills are excellent, business ability is top. State-level inspectors are the highest honor among inspectors and the highest and strongest group in China.
    drug inspectors are both an honor and a responsibility. Everyone comes from the bureaus of the General Administration, local inspection agencies, inspection agencies, and some from local review bodies, as well as adverse reaction monitoring agencies. But you have a common identity, and that's the "national drug inspector." When you carry out the inspection task, you represent the image of China's food and drug regulatory ad li, the ability of China's food and drug regulatory, and the level of China's food and drug supervision. Your duty is to ensure the quality of Chinese food and medicine and the health of the people. I hope you will bear in mind today's oath, perform your duties, not insult the mission, maintain the image of the inspection team, safeguard the honor of China's food and drug inspection agencies, and be a loyal guardian of people's health.
    drug inspectors should dare to stick to their principles. Clinical trials, production processes, and transportation, storage, and sales of drugs are strictly regulated. These specifications are our inspection criteria. The problems found in the inspection must be truthfully documented, truthfully reflected, meticulous, and unselfish. Never let go of any problem that may affect the quality of the drug, or affect the safety and effectiveness of the drug. We all shoulder important responsibilities in promoting the industry to form an atmosphere of advocating science, respecting science, doing medicine in good conscience and obeying the law. In the drug registration stage of the inspection, around the authenticity, consistency and feasibility of the market, strictly control the market of drugs. In drug GMP follow-up checks, data is complete, true, and traceable to ensure continuous compliance with the production process. In the cause of inspection, we should dare and be good at exposing the "subliminal rules" and crack down on illegal and illegal activities.
    drug inspectors should be strictly disciplined. The inspection relates to the overall situation of drug supervision. The greater the responsibility, the higher and more stringent the requirements. Inspectors carry out inspection tasks, just as soldiers on the battlefield to obey the arrangement of dispatch, obey orders and command, can not be their own;, how to be a qualified inspector, first of
    all, to be loyal to their duties. Inspectors should be three "loyal". First, be loyal to the Party and the people. The inspector is the representative of the public interest, the exerciser of the public power of the state, and the keeper of the health of the people. Therefore, we should fulfill our duties in a spirit of high responsibility to the Party and the people's cause. Second, be true to the law. Laws, regulations, regulations, norms, this is every pharmaceutical practitioners must strictly abide by the "rules of the sky", regulators, regulators must be in awe of this. Our inspectors are the defenders and enforcers of these "bars of heaven". Third, we should be loyal to the cause of food and drug supervision. Food and drug regulation is a public service and an important part of public safety system. It is the sacred duty of our food and drug regulatory authorities to ensure the quality and safety of food and medicine. It is up to our inspectors to enforce the law strictly on the front lines in carrying out this sacred duty. We have chosen this profession, to devote themselves to this cause, we must be loyal to this profession, loyal to this cause.
    second, have five abilities. One is the ability to judge right from wrong. When examining, the judgment method and illegal, it seems relatively easy to say, but in the first line of inspection may be judged between millimeters. It's a thousand miles, it's a thousand miles. To have the idea of discerning right from wrong, have the ability to judge right from wrong. It takes expertise and courage to make a qualified judgment on each indicator. It reflects the ability and quality of the inspectors. The second is the ability to spot problems. Food and drug supervision, focusing on the discovery of problems, the discovery of hidden dangers, whether to find problems, this is a major test of the ability of inspectors. Find problems, ask questions, in order to solve the problem, eliminate hidden dangers, in order to ensure the quality and safety of food and medicine. Third, the ability to audit cases. General Secretary Xi Jinping has called for the punishment of everyone for every violation of the law. We now this kind of administrative law enforcement inspection, often concerned about what illegal acts of enterprises, but the violations are committed by specific people. In the future, the inspection and inspection of food and medicine, all found violations of the law, should be implemented to the direct responsible person, indirect responsible person. Only by imposing penalties on natural persons for every violation can we be deterred by such checks and penalties. This requires our inspectors to learn to take evidence, to make on-the-spot inspection records, to have legal effect in court. Fourth, the ability to study inspection methods. Now we food and drug inspection, inspection, have prescribed standards, codes of conduct. But some enterprises and individuals in order to maximize the interests, do everything possible to find ways to circumvent these standards and norms. Check according to existing standards and specifications. May be qualified, but there is also "false negative". To these problems, we must be good at discovering, dare to expose, and to study the way to crack these "subliminal rules", the rectification of Ginkgo biloba preparations is a good case. Inspectors at the national level should have the capacity to study methods and develop them. So inspectors should also engage in scientific research, you have a lot of first-line practical experience, to be good at finding clues. Fifth, the ability to express words. We need a large number of inspectors, hope that the national inspectors, not only their own can do, but also will communicate, will summarize, will write articles, make up teaching materials, with apprentices. Write articles with a clear point of view, strict logic, accurate data, and concise language. You are the seeds, scattered to the whole country to bring out a large number of qualified inspectors, to promote the whole food and drug inspection capacity level.
    third, to be familiar with four aspects of knowledge. First, we should be familiar with food science, pharmaceutical science expertise. Check food, medicine, to understand the relevant professional knowledge, it is what composition, what kind of chemical principles, what kind of production process, this is the inspector's line. Food and drug inspection is a professional job, there is a threshold, not any one person can do. Second, we should be familiar with the basic knowledge of law and law. We are in the performance of our official duties, representing the public power, to understand the procedures of the law, to know how to collect evidence of violations of the law, to achieve legal procedures, effective evidence. In particular, the investigation of cases, prosecution, evidence to be legally relevant. Third, we should be familiar with the basic knowledge of computer applications. Check the enterprise's research and development, production, operation, require data to be truthfully recorded, timely records, all data should be traceable, not tampered with. Now enterprises have realized computerized management. Inspectors should be familiar with the basic knowledge of computer applications, of course, a little deeper, understand the computer expertise is better, which is also an important test of our ability to check. Fourth, we should have the basic knowledge of financial analysis. Any illegal act has an economic interest and a profit motive. Last year's Ginkgo biloba preparation case, a plate of 24 pieces of Ginkgo leaf tablets, the cost can not be less than 1.8 yuan, but some enterprises can actually sell to 1.2 yuan, do not fake how can make this medicine? Some say that the loss of this product depends on other products to make a profit, such a reason is also untenable. Selling drugs at prices below cost destroys legitimate enterprises, which is unfair competition, an economic crime and harms the public interest. It is time to be particularly wary of the phenomenon of "falsely low" prices in addition to inflated drug prices. Price pressure to such a low, whether the product is still qualified, this is our drug inspection, testing to pay attention to the risk. Therefore, we should learn the knowledge of economics, learn the knowledge of corporate financial accounting.
    fourth, we should cultivate three styles. First, scientific and pragmatic style. That's the truth. We can only return to science without making falsehoods. Inspectors must be scientific and pragmatic, do not indulge, do not wrong people, can not condone illegal behavior. Second, rigorous and meticulous style. The world is afraid of serious words, the Communists are the most serious.
    inspectors do meticulous work. Just looked at the display board of your work, some inspectors went to the countryside to check the results of vaccine clinical trials, lighting candles to light the night battle. There are clinical trial verification, in so many clinical trial data to see contradictions and problems, it is not easy. To find signs of breaking the law, to explore and restore the illegal facts behind it, you need to be rigorous and detailed. The third is the style of thunder. Inspectors are as tasked with inspection as soldiers are ordered to lift a gun and go to war. Inspection is a very important part of the whole food and drug regulation, this link is the whole relationship. In particular, some have an inspection, may find the problem within a few hours of departure, some cases are fleeting. So obey the dispatch, obey the command. Especially part-time inspectors, usually we all have their own work, but there are inspection tasks, to be able to put your own work and the implementation of the General Administration assigned inspection tasks to coordinate well. When the General Administration needs it, be aggressive, lift your backpack and set off.
    the fifth, to establish three positive spirits. One is to stick to the principle of integrity. Principle is big or wrong, you can't trade principle. You can't be a qualified inspector without sticking to the principles. The second is just not the positive spirit. To be fair, fair, not moved by any interests, not moved by any private feelings, no one can say hello can not release water, otherwise loyalty to duty will be a problem. Third, the iron face selfless integrity. We have done a good job of verifying the data of this drug clinical trial, and it is important that our verification center comrades take the lead. At first, when there was no order of verification, they began to check from the hospital where their alma mater belonged, which is called iron-faced selflessness.
    sixth, stick to three bottom lines. One is that there is no private law. The second is not to accept bribes. No eating please, no gifts, no red envelopes, there are strict discipline rules. The third is not to reveal secrets. The General Administration of Food and Drug Administration is in the process of establishing rules for staff to keep secrets. Can't keep secrets for the subject of supervision, so who dares to trust you?
    above is how I do a qualified inspector, put forward six aspects of the requirements for your reference., speed up the establishment of a team of professional inspectors
    the central government called for the establishment of a unified and authoritative food and drug regulatory system, the authority of the sign, that is, inspection, review of professional, technical. The ability and level of inspectors and reviewers is an important symbol of the authority of China's food and drug regulatory agencies. Therefore, we need a large number of highly qualified inspectors. Drug inspection was originally based, we have worked for many years on the basis of the formation of a national inspector system, this appointment of 649, but not enough. We also need food inspectors, medical device inspectors. We need it not just at the national level, but at the provincial, municipal and county levels. Besides, our team is really not professional enough, not professional enough.
    The CPC Central Committee and the State Council attach great importance to the construction of the food and drug inspector team, and in the Outline of the "Healthy China 2030" Plan, the Outline of the 13th Five-Year Plan for National Economic and Social Development, and the Opinions of the State Council on reforming the system of examination and approval of pharmaceutical and medical devices, it has been proposed to establish a team of food and drug inspectors. This is the Party Central Committee, the State Council to our greatest concern and love. Now the General Administration is studying the establishment of a professional team of inspectors, the most important thing is two aspects: First, to solve the problem of the professional development of inspectors. Establish a hierarchical management system for inspectors, open the channels for the promotion of inspectors, so that inspectors become a promising, promising and promising career; Inspectors are high-tech occupations, pay treatment should be closely linked to the skills it inspects, the level of inspectors, workload, so that inspectors this profession can really recruit people, retain people, especially so that our grass-roots regulatory agencies can retain people.
    our various supervision departments, provincial supervision offices, municipal and county supervision sections, staff must have the qualifications of inspectors. We select the leading cadres of supervision posts, we must be qualified from the inspectors, especially in the first line engaged in inspection, with rich experience in the selection of inspectors, which can reflect the professional characteristics of the food and drug regulatory departments, professional characteristics, in order to ensure the quality and level of food and drug supervision. Inspectors need to be able to be multi-er. Drug inspection, divided into clinical trial examination, drug production inspection, drug management inspection, according to the variety of inspection, but also divided into chemical drugs, traditional Chinese medicine, Traditional Chinese medicine, other ethnic medicine, biochemical products, biological products and so on, each has its own professional, each has its own characteristics. Food is divided into 28 categories, said to have industrial production of food, farmers directly produce, in the market for the sale of edible agricultural products, catering industry. Production, circulation, sales also have their own inspection requirements. In the future, the inspector's treatment depends on what can be checked, to be linked to the skills available, to be linked to technical positions, to be linked to the amount of work completed, which is called performance pay.
    today we are holding a swearing-in ceremony for drug inspectors, and we hope to hold a swearing-in ceremony for food inspectors and medical device inspectors in the near future. It is hoped that the cadres and workers of food and drug supervision at all levels will actively sign up to take the examination and examination and become professional inspectors. Also hope that all aspects of talent examination inspectors. The verification center is recruiting horses. We should work together to truly professionalize and professionalize the food and drug inspection team.
    , inspectors have made significant contributions to food and drug regulation over the past few years. Such as clinical trial data verification, Ginkgo biloba preparation market, calf blood injection drug market, the whole industry caused a strong response. I hope you will continue your efforts and make new achievements to promote the health of the whole people and make new contributions to the overall well-being of the whole people.
    thank you all. (State Administration of Food and Drug Administration)
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