SFDA Drug Safety Rectification Report Materials

SFDA Drug Safety Rectification Report Materials

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Since the second half of last year, in accordance with the unified deployment of the provincial government to carry out special drug safety rectification, with the great attention of the municipal government and the strong support of relevant departments, our city has carried out special drug safety rectification in a solid and effective manner. After nearly a year and a half of scientific supervision and vigorous rectification, the rectification target is progressing in a solid and orderly manner, the order of the drug market in the city has further improved, the long-term mechanism of drug supervision has been further improved, the drug safety situation in the city has steadily improved, and the special rectification activities have achieved remarkable results. The relevant information is hereby notified as follows:

First, widely publicize and mobilize, and organize self-examination and self-correction. Adhere to extensive publicity and overall mobilization, mobilize the attention and enthusiasm of the people and social organizations, give play to the role of drug-related machinery units as the main body of the market, and organize drug-related machinery units to seriously carry out self-examination and self-correction, laying a solid foundation for the in-depth development of special rectification. First, the special rectification of drug safety should be closely combined with the efficiency construction of organs, the activities of studying and practicing Scientific Outlook on Development, and the activities of entrepreneurship service year. By sending letters and questionnaires, we humbly solicit opinions and suggestions from all walks of life, introduce the food and drug safety situation in our city, the division of functions of relevant regulatory departments, the measures and effects of food and drug supervision, and mobilize their enthusiasm for paying attention to and supporting the special rectification of drug safety. Second, make full use of television, radio, newspapers, Internet and other media, strengthen the publicity of the significance of drug remediation and related laws and regulations, popularize the public's knowledge of rational drug use, report work trends, popularize advanced experience, and expose typical cases. According to preliminary statistics, the city * * * distributed 387 million publicity materials, posted more than 8,500 posters, hung more than 2,800 propaganda slogans, and published 67 propaganda manuscripts in the media at or above the county level. The third is to urge drug-related machinery units to seriously carry out self-examination and self-correction and implement rectification measures. 920 medical device production and operation enterprises in the city's jurisdiction are fulfilling their obligations to their own enterprises? The first responsible person? Responsibility, strengthen the quality and safety management of medical devices and other issues have been seriously investigated and dealt with, and consciously rectified from hardware and software. 100 More than medical institutions at or above the county level and large and medium-sized private hospitals pay more attention to the storage and maintenance of medical devices, and various systems are gradually improved, and various maintenance facilities and equipment are gradually improved.

The second is to highlight the key points of rectification and focus on solving outstanding problems. On the basis of ensuring that the special rectification of drug safety covers all drug-related equipment units, the city highlights the key points of rectification and determines key areas, key objects, key varieties and key behaviors, that is, focusing on rural and urban-rural fringe areas, focusing on drug production and wholesale enterprises, large retail pharmacies, medical device production and franchise enterprises, medical institutions at or above the county level, private hospitals and township health centers. Focusing on seven categories of drugs such as biological agents, blood products, vaccines, injections, stimulants, special drugs and essential drugs, and high-risk devices such as orthopedic implants and disposable sterile medical devices, we will adhere to the combination of special rectification with daily supervision and the implementation of the basic drug system, focus on solving outstanding problems in the production, circulation and use of medical devices, establish a mechanism for ensuring the production, supply and quality of essential drugs, and eliminate potential safety hazards in time.

Third, in the circulation link, the implementation of GSP by pharmaceutical trading enterprises was comprehensively inspected. In the whole city, 23 pharmaceutical wholesale enterprises and 637 pharmaceutical retail enterprises were tracked and inspected by flight inspection, 69 enterprises with serious illegal problems were investigated and dealt with, and 5 pharmaceutical wholesale enterprises without legal personality were cancelled. Carry out the renewal of drug trading enterprises, and 23 wholesale enterprises and 436 retail enterprises in the city have completed GSP certification and renewal. Drug administration, industry and commerce, radio and television and other departments cooperated closely to crack down on false and illegal advertisements. The city has monitored more than 240 advertisements for drugs and medical devices, investigated and dealt with illegal drug advertisements 17, and taken measures such as forced removal from the shelves and suspension of sales for drugs and medical devices with serious illegal advertisements, which further improved the order of drug advertisements in the city.

The fourth is to consolidate and improve and establish a long-term supervision mechanism. We insist on consolidating and improving the achievements of special rectification, running through the whole process of special rectification of drug safety by establishing a long-term supervision mechanism, refining and improving effective measures in special rectification, forming systems and regulations, and establishing a long-term supervision mechanism for drugs. First, improve the joint inspection mechanism of departments and improve the level of joint law enforcement. The Food and Drug Administration cooperates closely with the departments of industry and commerce, radio and television, and vigorously rectifies false and illegal advertisements of drugs and devices; And cooperate with the health department to strengthen the publicity and implementation of rational drug use and the monitoring of adverse events of drugs and medical devices. Drug administration, health, public security and other departments jointly carry out special rectification of ephedrine compound preparation management to ensure that the supervision of precursor drugs is in place. The second is to improve the construction of medical device safety integrity system and improve the effectiveness of daily supervision. On the basis of ensuring the supervision and inspection coverage 100% of pharmaceutical machinery enterprises within the jurisdiction, we should pay attention to drug safety risks and corporate integrity, strengthen supervision according to the principles of product classification, enterprise classification and supervision classification, increase the frequency of flight inspection for pharmaceutical machinery enterprises with high risks, poor records, many complaints and reports and low credit rating, and appropriately reduce the frequency of inspection for other enterprises. The third is to improve the emergency management mechanism of drug safety and improve the emergency response capability. Improve the emergency plan for drug safety emergencies, strengthen the monitoring of adverse drug reactions and medical device adverse events, and promptly accept drug safety complaints and reports reflected by the masses. Strengthen the work of accident information submission, organize emergency training for sudden drug safety accidents in different links and fields, and improve the emergency handling regulations of relevant departments. The fourth is to strengthen the construction of dynamic monitoring system for medical equipment and improve the level of supervision informatization. Taking advantage of the technology, personnel and network advantages of the Municipal Telecom Company, we signed an agreement with the Municipal Telecom Company to install dynamic monitoring facilities in medical device production and operation enterprises in the city, continue to improve the construction of dynamic monitoring system for medical devices, make full use of electronic monitoring network, strengthen network operation, maintenance management and abnormal flow monitoring, and give play to its important functions such as early warning of abnormal flow of special drugs and traceability of ordinary drugs. Explore the establishment of drug safety supervision information system, improve the safety supervision information collection and communication mechanism, and improve the supervision efficiency.

Although many achievements have been made in the special rectification of drug safety in our city, there are still the following problems: mainly the uneven development of work in various places, the lack of in-depth work in some places, and insufficient supervision and inspection and strict law enforcement. In the next step, the city will take this special rectification and supervision of drug safety as an opportunity to conscientiously implement the work requirements of the provincial inspection team, check and fill gaps, improve deficiencies, further strengthen work measures, and continue to further promote the rectification of all aspects of drug production, circulation and use.

First, continue to implement the responsibility for special rectification. Urge the governments of counties (cities, districts) and relevant departments directly under the municipal government to further implement the responsibility of drug safety special rectification, earnestly implement the responsibility of the first person responsible for drug safety in the production, management and use of medical devices, and ensure that the objectives and tasks of drug safety special rectification for two years are completed as scheduled.

Second, continue to improve the departmental cooperation mechanism. Actively coordinate and closely contact the relevant departments of drug supervision, establish a cooperation mechanism, improve the contact meeting system, form a joint effort of rectification, promote drug advertising supervision, sell drugs through mail, the Internet and other channels, and solve difficult and hot issues such as drug supervision in medical institutions.

The third is to continue to increase the intensity of inspection and handling cases. In view of the problems strongly reflected by the masses in the pharmaceutical market, we will resolutely rectify and severely investigate and punish illegal acts that harm the vital interests of the masses, actively explore new areas, new means and new ways of inspection and counterfeiting, and focus on investigating and handling a number of cases to ensure the safety of drug use by the masses.