Summary of drug supervision and inspection work

Summary of drug supervision and inspection work

In XX, under the correct leadership of the Party Committee of the Municipal Bureau and the County Bureau, under the correct leadership of the Party Committee of the Municipal Bureau and the County Bureau, we fully implemented the scientific development concept, changed the law enforcement concept, intensified the inspection, and seized the system. Construction, adhering to the administration according to law, and the inspection work have achieved good results, successfully completed the objectives and tasks of the inspection work formulated at the beginning of the year, and effectively maintained the economic order of the medical device market. Today, take this opportunity to report to the leaders and comrades on the main practices of the drug supervision and inspection work of the Bureau:

1. Unify thinking and understanding to ensure the smooth implementation of the audit work

Rectifying and standardizing the order of the medical device market is an important duty and sacred mission given by the party and the government to the drug regulatory department. It is an effective means to protect the safety and health of the people. To this end, the party group attaches great importance to the inspection work, and always keeps the inspection as the overall central work, insists on all the centers around the inspection, and in the case of very tense personnel, the first is to cooperate with the inspection personnel. At the same time, strengthen the audit responsibility, clarify the work tasks and individual post responsibility system, form a relatively centralized, relatively division of labor, mutual cooperation inspection work mechanism; priority in the enforcement vehicles to ensure inspection vehicles; developed a series of effective incentives Fully mobilized the enthusiasm and creativity of the auditors. The other departments and offices of the bureau fully supported and cooperated with the inspection work, and formed a case of investigation and handling of cases, no economic treatment, and a harmonious work situation in major cases, which laid a solid foundation for the inspection of the whole year.

Second, pay close attention to system construction, optimize the inspection and enforcement soft environment

First, according to the work objectives and tasks of the provincial and municipal bureaus at the beginning of the year, the bureau revised 11 rules and regulations such as law enforcement inspection, case handling, and law enforcement supervision in a timely manner, and revised the Administrative Law Enforcement Responsibility System to become the overall inspection and law enforcement personnel. A code of conduct for mutual compliance.
The second is to supervise the implementation system. In order to implement the rules and regulations of the administrative law enforcement responsibility system, the wrong account investigation system, and the clean and honest administration, the inspectors of the bureau regularly study on a regular basis, conduct monthly supervision and inspection on the implementation of the system, point out that there are problems and deficiencies, and require practical rectification. Plans and measures. Every inspector firmly established the diligence and integrity awareness, and the efficiency of the inspection and enforcement continued to improve. In the whole year, no complaints were received from the inspectors who did not act as a misconduct.

Third, pay close attention to team building and comprehensively improve the work level of auditors

First, strengthen the capacity building according to law. It is particularly important to establish a high-quality inspection team by inspectors who determine the level of audit work in accordance with the level of administrative level according to law. Our bureau adopts a combination of "going out, please come in". First, the director, Mr. Ye Younian personally led all the inspectors to Taihu, Fuyang and other places to learn the advanced practices of inspection and law enforcement, and invited other county bureaus and other brothers to come to me. The bureau sent auditing and law enforcement experience; the second was to select auditors to participate in the auditing and learning training courses organized by the Jiujiang City Auditing Collaboration Association and the National Bureau; once again, the inspectors insisted on one-day political theory, laws and regulations, and administrative learning according to law, and conducted typical cases. Analyze the discussion. Through various forms of training and training, the knowledge of the inspection and law enforcement personnel is constantly updated, the work ideas are not broken, and the administrative capacity according to law is continuously improved.

The second is to strictly regulate law enforcement. In the specific law enforcement case, we require law enforcement personnel to do law enforcement work in the following four aspects: First, fair law enforcement, no matter which unit or individual involved in the investigation, it must be investigated and dealt with according to law; The program must hold the certificate and illuminate the law enforcement. It must provide the basis for punishment to the relatives, and inform the discretionary powers and administrative litigation or the right and way to apply for reconsideration. The third is scientific law enforcement, that is, it is necessary to pay attention to strategies in handling cases. Paying attention to the collection and utilization of network information. In September last year, we combined the "Chinese Pharmacopoeia" according to the auditing network information platform of this system to investigate the problem that a pharmaceutical manufacturer arbitrarily changed the validity period and storage conditions of the drug and did not conform to the national standard; The fourth is to strictly implement the specific provisions of the "five public", "ten inaccurate" and "six injunctions" of the provincial government on administrative law enforcement, to achieve clean law enforcement, not to accept the administrative counterparts a penny, to make themselves clean, innocent Be a man.

The third is to improve the production level of the case file. The quality of the case file production reflects the level of law enforcement. From the beginning of the inspection work at the beginning of the year, we put forward specific requirements for the study and discussion of the production of law enforcement documents, the review of case files, and the centralized clean-up of documents with irregular language and format. At the same time, it is pointed out that a qualified punishment document must objectively reflect the whole process of the formation of the punishment decision. It includes both the program and the entity. The words used in the sentence must be meticulous. The language of the law enforcement document must be accurate and concise, and the writing should be uniform, standardized, and neatly written. Clear. The quality and binding of the production of the case file of our bureau was well received by the inspection team of the county people's congress and the inspection team of the municipal bureau fully affirmed that the quality of the case file was also recognized by the provincial bureau leaders in the case file inspection organized by the provincial bureau.

Fourth, change the law enforcement concept and realize the four transformations of the audit work. One is to realize the transition from “behavioral punishment” to “quality penalty”. Our bureau has established a correct supervision concept. The daily supervision and special inspections are combined to concentrate on the investigation and punishment of quality penalty cases. We have carried out a number of inspections, such as medical equipment, condoms, medical equipment packaging, labels and instructions, etc. Special sampling of regional and key varieties. In the whole year, 126 cases of “quality penalty” were investigated and dealt with, which was significantly increased compared with previous years. The fines for counterfeit and inferior medical equipment accounted for 258,000 yuan.

The second is to realize the transition from simple sampling to supervision and inspection. Drug inspection and drug inspection are two important parts of drug supervision and management. First, all inspectors are required to collect information on counterfeit and inferior drugs from the Internet, media and people and units, and arrange special personnel to collect, screen, summarize and establish fakes. Inferior drug information database; secondly, drug sampling inspection combined with daily supervision and various special inspections, the drug sampling inspection work is integrated into the inspection work, giving full play to the technical support role; the third is to establish fake and inferior drug display cabinets, which are easy for the market. The counterfeit medicines that appeared appeared to be compared and compared with the fake products in the "Chinese Pharmacopoeia" one by one, and accumulated a lot of practical experience in the identification of authenticity. In the whole year, 109 batches of random inspection tasks were completed, 37 batches were unqualified, and the hit rate was 33.9%. More than 30 varieties of counterfeit and inferior drugs were seized, and the value involved was over 70,000 yuan.
Check out more drug supervision and inspection work summary of the new rural cooperative medical work summary in the first half of the year

The third is to achieve a shift from drug cases to medical device cases and drug cases. We take medical equipment inspection as a point to drive the inspection of medical equipment. In view of the current unregulated medical equipment market, expired, and no product registration certificate, the products are still flooding the equipment market. We are working hard to learn the laws and regulations related to medical equipment. Various standards have increased the supervision of medical devices and promoted the supervision of the entire medical device market. In the whole year, medical device cases accounted for 40% of the total number of cases, and the value of the device involved in the investigation was about 150,000 yuan.

The fourth is to realize the transition from law enforcement inspection to harmonious inspection. The essence of the harmonious inspection is people-oriented. Before every administrative punishment, in addition to propagating relevant laws and regulations, we strengthen the ideological communication and intensive education with the administrative counterparts, understand each other's emotions and reactions, and pay attention to strategies and methods. The law enforcement effect, rigid and soft, and practical, to achieve a task of special rectification activities, implement a check, standardize an act, and achieve a goal. The bureau advocates: the service consciousness of "serving in law enforcement and law enforcement in service", which implements the law-based administration and harmonious law enforcement throughout the whole process of inspection and law enforcement, and creates a good law enforcement atmosphere. There was no administrative reconsideration and administrative litigation cases throughout the year. Without a complaint case, the administrative counterparts took the initiative to perform administrative penalties.

In the past year's work, although some achievements have been made, there is still a considerable gap compared with the fraternal units. Therefore, in the new year, we must establish a scientific regulatory concept, fully understand the importance of drug supervision, fully understand the difficulties and challenges faced by the current drug regulatory work, further enhance the sense of urgency and responsibility, and adhere to scientific supervision. Administration, comprehensively carry out rectification and standardization of the order of the pharmaceutical machinery market, and re-innovate performance to ensure the safety of people's medication.