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Summary of drug inspection work


In xxxx years, the drug supervision and inspection departments at all levels of the city, in accordance with the unified arrangements of the leaders of the provincial bureaus and municipal bureaus, adhered to the scientific supervision concept and established a sense of work for law enforcement for the people and service development, working hard under the hard work and joint efforts of the vast number of inspectors. Focusing on the goal of “Building food and drug safety in Changzhou and promoting coordinated economic and social development”, we will continue to insist on counterfeiting and inferiority, continue to rectify and standardize the drug market order, and better fulfill the duties of the drug inspection department to ensure the people of our city. The public has made due contributions to the safety and effectiveness of medical equipment and the healthy development of the pharmaceutical industry, and has successfully completed various tasks.

As of December 15 this year, the city's drug inspection and inspection departments at all levels dispatched 9,220 law enforcement personnel, inspected 3,750 homes, received 209 reports, received 209 reports, filed 225 cases, and imposed administrative punishments on the spot for 483, banned 13 One unlicensed drug sales point was handed over to the public security organ.

First, continue to maintain the high pressure situation of severely counterfeit and inferior drugs, to ensure that the pharmaceutical market is standardized.

Drugs are special commodities that affect the lives and health of the people. Strengthening drug supervision and management and ensuring the safety and effectiveness of drug use by the people are the sacred duties of the party and the people to the drug supervision and administration departments at all levels. According to the spirit and requirements of the Provincial Bureau's "Notice on Carrying out Quality Inspection of Basic Drugs and Medical Devices in the Province" (No. 50), the drug inspection and inspection departments at all levels of the city earnestly studied and implemented the spirit of the Provincial Drug Supervision and Inspection Work Conference, unified thoughts, and further To raise awareness of the importance of drug supervision and inspection work, continue to take the illegal activities of cracking down on the production and sale of counterfeit and shoddy drugs, medical devices and illegal production, operation, use of drugs and medical devices as the focus of this year's inspection work. Seriously carry out quality inspections of primary medicines and medical devices. Focusing on rural areas, focusing on the circulation and use of medicines and medical devices, the provincial bureau has severely cracked down on the production and sale of counterfeit rabies vaccines and human albumin drugs, arbitrarily adding pharmaceutical active ingredients, and manufacturing counterfeiting at home and abroad. Based on 8 special supervision and inspections of well-known brands of pharmaceutical products, postal sales of fake drugs, pseudo-drugs, false advertising drugs, super-mode or over-range operations, and physiotherapy equipment products, combined with the actual situation in Changzhou, detailed and practical Special supervision and inspection work implementation plan. For each special inspection, we pay attention to improving the efficiency of supervision, combining daily inspections and special inspections to achieve one inspection and comprehensive consideration, which not only improves the efficiency of inspection, but also reduces the cost of law enforcement, and also reduces the relative The impact of people's daily work. At the same time, it will strengthen joint operations with the public security, health, industry and commerce departments, and investigate and deal with cases involving multi-sectoral jurisdiction by means of joint inspection and timely handover.

Second, do a good job in the supervision and inspection of drugs to ensure the safety of people's medication.

In order to improve the level of sampling, we organized the city's inspectors to conduct a careful analysis and research on the quality of drugs in the drug supervision and sampling work in XX years, to sum up experience, to find deficiencies, and to open up new ideas for our supervisory inspection. . In view of the unqualified varieties and their distribution in the sampling test, determine the general drug sampling ideas of this year, scientifically and rationally organize the drug supervision and sampling work; further improve the performance evaluation of Changzhou drug quality supervision and inspection according to the "Jiangsu Province Drug Testing and Examination Rules" "Measures"; adhere to the principle of daily supervision sampling test, supplemented by special sampling inspection, further improve the fairness of sampling, and ensure the coverage of drug testing. Strengthen the inspection of the varieties of the market in the past two years. The focus of drug testing is on the large quantities of commonly used drugs, low-cost drugs, first-aid drugs, and unstable-quality drugs that are closely related to the health of the people, as well as drugs that have failed to pass the test, and put them on the quality of drugs. More areas and units. While increasing the coverage of production enterprises, we will focus on strengthening the inspection and testing of circulation and use, especially for basic drug business units and medical institutions. Strictly investigate and punish the unqualified samples, and further standardize the drug test report delivery program to keep abreast of the quality inspection of drugs and medical devices, and to make unqualified drugs and medical devices involved in local production in national and provincial quality announcements. Go to 100% tracking.

Third, do a good job in the basic construction of drug inspection work and improve the level of inspection and law enforcement.

1. Strengthen the business learning and training of auditors and focus on improving the overall quality of the audit team. In order to comprehensively improve the comprehensive investigation level of the investigation, in order to better meet the needs of the current special rectification work in the pharmaceutical market, organize inspection personnel to exchange and study at the inspection office of Wuxi Food and Drug Administration; organize inspection system personnel to study the Jiangsu Drug Administration Regulations. "Special Provisions and Medical Device Supervision and Enforcement"; convening a training course for inspectors in the city: lectures by Director Wang of the Anti-Defamation Infringement Bureau of Zhonglou District, Changzhou; and Director Jiang of the Municipal Bureau of Urban Security, explaining the contents of gmp; Pharmaceutical Co., Ltd. field visits; organized comrades in all departments to seriously study the " implementation plan for the construction of XX organs"; carefully drafted the contents of the drug inspection and investigation work part of the "National Drug Inspection Workbook" prepared by the National Bureau. The first draft of the Changzhou Bureau inspectors participated in the compilation, and has passed the provincial bureau review; the “XX Year Assessment Target” has been carefully revised; in order to meet the leadership of the provincial bureau Li Jiping and other leaders, the investigation and the provincial administrative “responsible law enforcement responsibility system” inspection, inspection The department has earnestly done relevant materials and preparations for "administration by law and scientific supervision".

2. Improve the system, further improve the standardization level of the inspection and law enforcement work, and fully implement the application of the rational documents. In order to further standardize the administrative law enforcement behavior, improve the efficiency of administrative law enforcement and the administrative punishment cases, find out the existing problems, and establish an advanced model of the investigation case file. The evaluation of law enforcement files was carried out in the city's drug inspection system. In particular, the law enforcement officers of the Wujin Bureau have made great efforts. They took time out in the process of handling the case, and collected a large number of experiences and advanced experiences of other departments using the rational documents through the Internet, and combined with the actual situation of the drug supervision department, A detailed discussion was repeated, and the basic format of the rationale was established in a short period of time, and a computer document template was made and distributed to each supervisor and inspector. Therefore, the administrative law enforcement procedure is more open and more transparent; it enables the parties to clearly understand all the procedures and details in the investigation process of the case; so that the parties can fully understand their illegal nature and prevent them from committing the same or similar mistakes next time. The full exercise of discretion is fully explained. The New North Bureau has also significantly improved the quality of the case file in the case of a small number of people. In terms of improving the system, the Municipal Bureau of the Municipality has cleaned up the confiscation of material warehouses and established a ‧ annual confiscation of materials work accounts; the audit office has carried out a rotation system in the internal work. We do report calls 24 hours a day, 7 days a week, to ensure that all complaints are not missed. In order to further implement the "Notice of the Provincial People's Procuratorate Provincial Public Security Bureau of the Provincial Food and Drug Administration, the Provincial Public Security Department to jointly crack down on the summary of the joint action on drug-related crimes", severely crack down on drug-related crimes and effectively protect the safety of the people's use of drugs, A joint meeting of the Changzhou Food and Drug Administration, the Municipal Intermediate People's Court, the Municipal People's Procuratorate, and the Municipal Public Security Bureau was held: Establishing a joint conference system for investigating and dealing with drug-related crimes in Changzhou. Establish a transfer system for drug-related crimes in Changzhou. Establish a joint case handling system for certain cases of poor nature, large social impact, and possible use of medical equipment safety hazards.

3. Implement the inspection and law enforcement responsibility system, and strictly enforce the law and serve enthusiastically. In order to improve the transparency of law enforcement, strengthen social supervision, and open to the public to accept reports, handle time limits, supervise telephone calls, etc., to make government affairs open. At the same time, in the process of administrative law enforcement, we strictly produce the "Administrative Law Enforcement Certificate" in accordance with the relevant laws and regulations; if we give administrative punishment, we shall inform the illegal facts, the punishment basis, the statement, the defense or the hearing right in strict accordance with the notification and hearing procedures, and civilized law enforcement. In order to convince people, courteous people, set a new image of drug inspection and law enforcement.

4. Implement the responsibility system for building a clean government and strengthen the integrity of the inspection team. In accordance with the "Comprehensive Target Responsibility" signed by the beginning of the year and the "Responsibility of the Party's Style and Clean Government", we have continuously strengthened the integrity education of the inspection and law enforcement personnel in light of the actual work. Through the activities of the meeting, talks and other activities, the law enforcement personnel continue to improve the consciousness of implementing integrity discipline. Organized a symposium of the heads of pharmacy departments of medical institutions, informed them of the city's drug inspection work, and carefully listened to and solicited their work style, service quality, service attitude, efficiency, civil law enforcement, integrity and self-discipline. Comments and suggestions for problems. According to the feedback from the administrative counterparts on the drug inspection work and the case visits of the discipline inspection and supervision organization of the bureau, the satisfaction rate and basic satisfaction rate of the inspection work reached 100%. The administrative law enforcement work of our office was recognized by the people.

Fourth, do a good job in the two constructions to provide a new working model for drug inspection work.

1. Drug packaging database of all pharmaceutical manufacturers in Changzhou

Every year, we have to send hundreds of consultation letters to the drug regulatory authorities across the country. At the same time, we also need to deal with a large number of letters from the foreign drug regulatory authorities, mainly to verify the authenticity of the drugs produced by local pharmaceutical manufacturers. A considerable part of it is more urgent. The information base of pharmaceutical packaging materials provides a good foundation for us to quickly crack down on counterfeit drugs and effectively curb the occurrence of fake and fake sales. Up to now, through the database of filing materials, it has assisted the foreign drug regulatory authorities to quickly identify 20 authenticity of drugs, involving the counterfeiting of four production enterprises, five varieties and 15 batches of drugs in the city, which has been well received by the investigation department.

2. Changzhou City's Counterfeit Drug Information Database

As the saying goes, eating a long and a wise, we must not allow fake drugs that have already been discovered to slip through our eyes. The counterfeit drug information database can inform consumers how to identify counterfeit drugs. The pictures and captions in the database are uploaded on the exposure desk of our website. All the people browsing the website can clearly understand the fake drugs found in the city, which not only helps the public to avoid the violation. It also played a role in mobilizing people to find fake drugs. At the same time, we also combined the “food and drug safety into the grassroots volunteer publicity service activities” to bring the fake medicines and fake photos we found to the community activities, so that the fake drugs themselves “show”. This vivid and lively way has been welcomed by the people, especially the middle-aged and elderly people, and the publicity effect is very good. The establishment of the fake medicine packaging information database will provide a new working mode for cracking down on the crime of manufacturing and selling counterfeit drugs and strengthening the work of drug inspection.

The inspection work has a long way to go, and the inspection work is arduous and glorious. We must invigorate the spirit, forge ahead, work diligently, live up to the responsibilities entrusted to us by the party and the people, and escort the people in the Changzhou area to ensure the safety of medicines and make due contributions.

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