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Drug inspection year-end summary


In order to conscientiously implement the spirit of the province's food and drug supervision and management work conference and the video conference of the national drug market supervision work in xx years, severely crack down on illegal and criminal activities such as the production and sale of counterfeit and inferior drugs and medical devices, and direct guidance in the unified leadership and supervision of the party group Next, this year, the province's drug supervision and inspection work focused on the following aspects.
First, the main work of XX
Xx years of the province's drug supervision and inspection work conference was successfully held
On March 6-7, xx, the provincial drug supervision and inspection work conference was held in Wuxi. Director Zhu attended the meeting and delivered a speech, stressing that the anti-counterfeiting and inferior high-pressure situation will remain unchanged, the determination to investigate and deal with major cases remains unchanged, and the incentive policies formulated by the provincial bureaus will remain unchanged. For this year's work, Director Zhu asked for a focus on seven aspects of work. First, we must clarify the work targets for the whole year as soon as possible, continue to maintain the high-pressure situation of drug counterfeiting and inferiority, and consolidate the results of special rectification; second, we must pay close attention to the investigation and handling of major cases, and the cases of socially harmful, bad nature, wide-ranging and suspected crimes. At all costs, trace the roots, check and check through; third, we must vigorously improve the efficiency of the inspection work, highlight the three words of "fast", "quasi", "狠", improve the technical support system for drug inspection, improve inspection and testing capabilities, and strive to promote inspection Fourth, we must further strengthen the supervision work, strengthen scientific assessment, and strengthen supervision work; Fifth, we must constantly innovate in the concept of law enforcement, innovate in the inspection work system, means and methods, and innovate in technical supervision; It is necessary to organize and hold the first "7+1" drug supervision and auditing joint defense cooperation zone meeting, focus on creating an efficient auditing and prevention cooperation platform, and form a counterfeit and anti-drug combination of drugs; seventh, we must do a good job in building the capacity of the inspection team and improve the overall quality of the inspection team. The party's style and clean government education has continuously enhanced its ability to resist corruption and prevent change.
Highlight the focus of the inspection work, and pay close attention to the investigation of major cases
In XX, under the direct leadership of the provincial bureau leaders, the system-wide inspectors worked hard to break through some cases involving a wide range of influences, bad influences, and serious violations of the interests of the people. The more influential big cases are:
1. In April XX, the Dongtai Bureau received reports from the public and found that the “Linzhi Eye Drops” sold in a wholesale market was a counterfeit drug, and the copies of the relevant certificates were forged. Due to the facts of the case and involving other provinces, the provincial bureau quickly listed the case as a supervised case. With the assistance of the public security organs, the Yancheng Bureau and the Dongtai Bureau, after more than 20 days of hard work, arrested 4 people in the counterfeiting group headed by Tu, and destroyed the fake dens in Nanning, Guangxi. The amount involved in the case amounted to more than 10 million yuan. Sales outlets cover 22 provinces and 120 counties across the country, with 142 people involved. At present, the public security department has arrested 7 major criminal suspects, and the investigation of 137 down-line salesmen of Tu is under intense work.
2. In January XX, Nantong Bureau and Tongzhou Bureau cooperated with the local public security organs to investigate Gao’s sales of fake drugs, arrested 18 criminal suspects, and seized 75 fake human albumins and more than 400 fake rabies vaccines. . Gao bought the blood albumin from Zhao, a certain place in Zhaozhou, Anhui Province, and sold it to Tongzhou, Rugao, Rudong and other places. Many patients had serious adverse reactions, and 3 of them died after being rescued. Into the fake rabies vaccine, causing the death of a patient in Taixing. At present, 6 people have been arrested according to law and 7 people have been detained in criminal detention. The case has been listed as a listed supervision case by the Provincial Public Security Department.
3. In January XX, the Taixing Bureau received a report from the public. A resident of Taixing suffered serious discomfort after being injected with a rabies vaccine at a clinic by a dog bite. He died after being rescued. After being examined by the provincial drug testing institute for the rabies vaccine, it was identified as a fake drug without active ingredients. Immediately, the Taizhou Bureau conducted a pull-net inspection of the fake rabies vaccine throughout the city. After investigation, the criminal suspect Gao and Shen had flowed into the Taixing fake rabies vaccine for 158 persons, 108 people had been used, and the remaining 50 were seized. At present, the public security organs have criminally detained 5 people including Shen and the case. The case is under further investigation and is listed as a supervision case by the Provincial Public Security Department.
4. In May XX, the Lianyungang Bureau received reports from the public, reflecting that there was an unlicensed denture processing den in the urban area. The bureau immediately dispatched personnel to the scene and inspected that the den was producing and processing custom dentures. The person in charge of the processing point, Zeng, was unable to provide the relevant legal license. The inspectors seized the relevant processing equipment, production raw materials, finished products and sales ledgers on the spot and handed the case to the public security organ. At present, the public security organs have criminally detained 3 people, involving more than 500,000 yuan.
According to incomplete statistics, from January to the end of this year, the province's drug regulatory inspection agencies dispatched 108,361 law enforcement personnel, inspected 39,415 drug, medical device production, operation, and medical institutions, and investigated 4,402 cases, with a value of 33,715,800 yuan, confiscated. The value of the goods was 6,318,500 yuan, and the fines and penalties were 4,687,110,000 yuan. 198 unlicensed businesses were banned, 24 fake dens were destroyed, and 14 judicial cases were investigated and dealt with.
To rectify the order of the pharmaceutical market and carry out the inspection of the quality of basic drugs and medical devices to consolidate the results of the rectification of the pharmaceutical machinery market in our province, and to cope with the new situation and new trends of the current drug-related, legal and criminal activities, and to cooperate with the Jiangsu Drug Administration Regulations. The promulgation and implementation of the company, from March 15th, xx in the province to carry out a six-month inspection of the quality of primary drugs and medical devices. The large-scale inspection operation focuses on rural areas, focusing on the circulation and use of medicines and medical devices, and severely cracks down on the production and sale of counterfeit rabies vaccines and human albumin drugs, unauthorized addition of pharmaceutical active ingredients, and the manufacture of counterfeit and domestic and foreign well-known drugs. Eight special supervision and inspections, such as branded drug products, postal sales of counterfeit drugs, pseudo-drugs, false advertising drugs, super-mode or over-range operations, and physiotherapy device products, are the key contents.
Strengthen technical support and carry out quality supervision and inspection of pharmaceutical medical devices
1. Release the provincial drug medical device sampling plan. In March xx, we issued a xx-year drug medical device sampling plan. A total of 20,400 sampling batches were arranged throughout the year, of which 20% were used for evaluative sampling of 40 categories of three major categories. In xx, the province's medical equipment and pharmaceutical packaging materials supervision and sampling plan arranged a total of 413 batches of 64 medical equipments such as orthopedic equipment kits and gastric lavage machines; 199 batches of 11 pharmaceutical packaging materials such as aluminum-plastic packaging composite film bags and ampoules Times. The work on sampling is currently in progress.
2. Carry out sampling of national drug medical devices. In xx, the National Bureau issued the drug sampling test for 35 varieties of amoxicillin tablets and live attenuated Japanese encephalitis vaccines, and currently completed 730 batch sampling tasks. According to the National Medical Device Quality Supervision and Inspection Program, the province has inspected a total of 120 medical device production, operation and use units, including 101 medical device manufacturers, 14 operating companies and 5 users. A total of 94 samples were taken.
Strengthening regional cooperation and conducting business training In order to achieve large-area resource sharing and coordinated efforts to eliminate regulatory blind spots, the province proposed to integrate the Shanghai-Suzhou-Zhejiang-Sulu-Yu-Yu two drug inspection joint prevention and cooperation zones, and held it in Yangzhou in April xx. The first "7+1" drug supervision and inspection joint defense cooperation zone meeting. The meeting signed the "7+1" Drug Supervision and Inspection Joint Defense Cooperation Zone Agreement and passed the "7+1" Drug Supervision and Inspection Joint Defense Collaboration Liaison System, and established and improved the regional joint prevention cooperation mechanism and promoted joint anti-counterfeiting. The issue was discussed in depth and the following consensus was reached: Eight provinces and municipalities should establish a “7+1” joint defense coordination zone as a new starting point, further expand the cooperation field, enrich the connotation of collaboration, improve the coordination mechanism, improve the level of collaboration, and jointly respond to the audit. A new set of challenges facing law enforcement and drug regulation work to meet the growing new and higher demand for dietary safety for the people.
From May 12 to 19, xx, the SIPO and the Provincial Police Officer College jointly organized the fifth training class for drug supervision and inspection personnel in the province. Director Zhu attended the opening ceremony and made an important speech. First, he devoted himself to learning with a full spirit. Second, he insisted on linking theory with practice and improved his work skills through learning. Third, he strictly adhered to training discipline and established drug inspection and law enforcement personnel. The good image of the training class, the effectiveness of the training class, the level of work, and the characteristics. In addition to the excellent teachers of the Provincial Police Academy, we also invited four system experts to proceed from the audit practice and arrange targeted and practical training content. The participants generally reflected that they have further mastered the knowledge of drug supervision business through training and improved the ability of inspection and law enforcement.
Second, XX year work arrangements and plans
In the XX year inspection work, under the leadership of the bureau party group, although some achievements have been made, there are some shortcomings, mainly in the following aspects: First, counterfeit drug cases in the vast rural and neighboring provinces have occurred from time to time. Thorough containment; second, the scientific and technological content of the audit work needs to be improved, the use of the audit management system is not satisfactory; the third is the comprehensive quality of some inspectors and the need to further strengthen the law enforcement capabilities. In short, the achievements are remarkable, but the problems that exist cannot be ignored. We are determined to seriously overcome and improve them in the second half of the year. Around the requirements of the provincial bureaus to "maintain the anti-counterfeiting and inferior high-pressure situation, investigate and resolve the major case resolutions, and the incentive policies formulated by the provincial bureaus remain unchanged", the specific work arrangements for the second half of the year are as follows:
Continue to pay close attention to the investigation and handling of major cases. We will promptly introduce the "Funding and Reward Measures for the Filing of Cases for Drugs and Medical Devices in Jiangsu Province Food and Drug Administration", and effectively guarantee the investigation and handling of major cases. We will always maintain the high-pressure situation of counterfeiting and inferiority, give full play to the advantages of the system, mobilize the inspections at all levels and the strength of relevant departments, and form a joint effort to break through some cases involving wide-ranging, harmful, and serious violations of the legitimate rights and interests of the public and enterprises. According to the potential characteristics, development trends and common problems of drug-related violations in the province, timely organize a case analysis meeting to guide the investigation and handling of cases.
Continue to do special rectification and supervision and inspection work. According to the annual inspection work arrangement and the work deployment of the national bureau, this year's grassroots drug medical device quality inspection activities and the supervision and sampling of drugs and medical devices should be said to have made certain progress and achievements. We must summarize the above work in the first half of the year. The characteristics and existing problems, actively guide the province to continue to do all the unfinished work, and organize the assessment of the system-wide drug testing.
Hold a "fake-proof brand name" and a joint meeting of the four parties. Further improve the work of combating counterfeit drugs and protecting well-known brand drugs, adhere to the principle of treating both the symptoms and the root causes, and constantly explore the fundamentals of the problem, and work hard to establish a long-term mechanism for counterfeiting and protecting the brand, and quickly communicate and cooperate with each other, overcome the high cost of safeguarding rights, and smash the source of counterfeiting. At the same time, we must vigorously play the role of public opinion propaganda, let the common people understand, the whole society pay attention, and form a social synergy of "counterfeiting and protecting famous brands." It is necessary to continue to improve the joint meeting system with the legal departments such as the Public Prosecution Law, convene a meeting of liaison officers, and focus on solving and coordinating the problems existing in the investigation and handling of drug-related crime cases.
It is necessary to further increase the intensity of supervision work. Inspectors of local inspections should pay attention not only to the completion of hard indicators, but also to the legality and standardization of each case in terms of substantive punishment, application of procedures, and use of discretion. In the form of supervision, it adopts various forms such as unified supervision, irregular inspection, random sampling and unannounced visits; in the focus of supervision, it is necessary to go deep into the case, especially the major case. At the same time, increase the assessment and notification of the use of the system-wide audit management system, and if necessary, increase the investment in the information-based tools required for audit enforcement.
We must do a good job in building the capacity of the inspection team. First, we must put a good governance. By strengthening the party's style and clean government education, every inspector will continue to improve their ideological consciousness, build an ideological and moral defense line, correctly treat the status of money, gains and losses from fame and fortune, and withstand various temptations and tests. Second, we must focus on improving the overall quality of the inspection team. In view of the lack of knowledge of medical devices and the shortage of medical device professionals in the whole system, we will carry out medical device inspection skills training in the second half of the year, and work hard to enhance the training and improve the timeliness of training. The third is to establish a harmonious relationship between supervision and supervision. All levels of inspection and law enforcement personnel must always adhere to the administration according to law, and must put services in supervision and law enforcement. Under the premise of handling cases according to law, help and support enterprises to accelerate development and actively build a harmonious regulatory relationship.
In XX, we have the determination to carry out the study and practice of the scientific development concept under the correct leadership of the provincial party group, firmly establish the concept of scientific law enforcement, always maintain the anti-counterfeiting and high-pressure situation, improve the efficiency of drug testing, and enhance emergency response. Ability to comprehensively improve the supervision level of inspection and law enforcement, and make a greater contribution to ensuring the safety of people's medicines.

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