County Drug Quality and Safety Special Rectification Action Program
County Drug Quality and Safety Special Rectification Action Program In order to conscientiously implement the spirit of the National Product Quality and Food Safety Special Rectification Television and Telephone Conference, according to the "LongYou County Product Quality and Food Safety Special Rectification Action Program" (LongZhenGongBanFa 〔XX〕 No.) and the "General Office of the People's Government of Zhejiang Province on Further Strengthening of Drug Safety Supervision Notice" (浙政办发[XX]号), and for the county of drugs, medical equipment safety of the outstanding problems, in accordance with the unified deployment of the county government, decided to carry out from late XX to the end of the month in the county of "drug safety rectification of the special action", the specific program is as follows.
First, the tasks and objectives
(a) special rectification of pharmaceutical production
Tasks: strengthen the supervision of pharmaceutical production enterprises, pharmaceutical excipients manufacturers must comply with the provisions of the unit to purchase materials, and in accordance with the provisions of the inspection and put into production and use; require the production of enterprises must be in strict accordance with the quality standards of pharmaceutical excipients production, inspection, strict quality control. Requirements for production enterprises must strictly in accordance with the quality standards for pharmaceutical excipients for production, inspection, strict quality control of products. Each batch of products should have sales records, and their sales records should be traceable.
Objective: Pharmaceutical production should ensure that the important production process can achieve continuous and stable operation. Ensure the fulfillment of each material, intermediate products, finished product inspection standards and methods used in accordance with the provisions of the implementation of inspection and sampling. Ensure the independent fulfillment of the provisions of the material sampling, unqualified materials are not allowed to put into production, unqualified products are not allowed to release, and shall not use raw materials without document number management.
(B) special rectification of pharmaceutical and equipment business
Tasks:, comprehensive supervision and inspection of drug business enterprises. Supervision and inspection of drug business enterprises must reach 100 percent coverage. Efforts to solve the drug business in the business of dependency, over the way and over the scope of business problems. Improve the coordination mechanism between the food and drug regulatory authorities and the public security organs, according to law, the supervision and inspection of the enterprises and the relevant responsible persons found to be problematic enterprises and seriously dealt with, in line with the conditions of referral of the case, must be resolutely referred. Strict access management of drug business. Comprehensive inspections of drug wholesalers and drug retailers are carried out in accordance with the quality management standard for drug business. For those that fail to meet the statutory conditions and requirements, we will recommend the relevant higher authorities to withdraw the Drug Operation License in accordance with the law. , strengthen the supervision of drug business behavior. It is strictly prohibited for drug retail enterprises to rent or transfer counters in any form, and drug retail enterprises are educated and supervised to strengthen the management of sales personnel. If a drug retailer operates a non-pharmaceutical product, it must set up an area for the exclusive sale of non-pharmaceutical products, and set up clear signs of zoning. In addition, rural drug supervision and advertisement special rectification have been strengthened. Continuing to promote the construction of rural drug supervision and supply networks, focusing on long-term mechanisms, exploring, summarizing and developing drug supervision models suitable for the actual rural areas of the county. Vigorously remediate false and illegal advertisements, and take administrative control measures against drug manufacturers and operators who illegally publish advertisements, in strict accordance with the provisions of the Measures for the Examination of Pharmaceutical Advertisements, and strive to remediate illegal pharmaceutical advertisements before the end of the year. The company has also strengthened the special inspection of implantable medical devices. The contents of the special inspection: whether the operating units of implantable medical devices are filed, and whether the using units have records from purchasing, acceptance, use and tracking inspection. Whether the establishment of medical device adverse monitoring records, whether there is the use of medical devices without product registration certificate phenomenon.
The goal: by the end of this year, the basic solution to the problem of dependence on the business, over the way and over the scope of operation of the drug; prohibit the ban on the name of the public figure, expert proof of the efficacy of illegal drug advertisements.
(C) special rectification of the use of drugs and equipment
Tasks: to strengthen the supervision of the use of drugs and equipment. Strengthen the monitoring of adverse reactions to medicines and medical devices, establish an early warning mechanism for drug safety information and control and processing mechanism, further increase the publicity, education, management and supervision of the rational use of clinical drugs, standardize the use of prescription behavior, improve the level of rational use of clinical drugs, promote the classification of drug management, and promote the rational use of drugs and improve the awareness of the community's safe use of medication.
Objective: To improve the rational use of medication in clinical practice and the safe use of medication.
Second, the content of work:
(a) drugs, medical equipment safety special rectification. Rectification focuses on the following:
, drug special rectification
() to strengthen the supervision of drug business behavior, investigate and deal with wholesale enterprises dependent on the operation of the phenomenon of over
ticket. Crack down on illegal behaviors such as renting out or transferring counters in drug retailing enterprises, as well as passing off food and health food as drugs and medical devices. () Carrying out special inspections of drug purchase invoices, investigating and dealing with illegal acts such as medical institutions purchasing drugs from illegal channels or rural individual clinics to retail pharmacies, as well as drug wholesalers supplying drugs to unlicensed units. (c) Carrying out special inspections on the quality of school medicines and equipment. Jointly with the county education bureau, inspect the procurement channels of drugs, drug maintenance, personnel qualification, and expiration date management of school dispensaries, and establish a long-term regulatory mechanism. () the county's medical institutions standardized pharmacy to deepen the construction of supervision, and promote the standardized management of medical institutions drugs. () Carry out special inspection of vaccine quality. The relevant units of the county's vaccine import channels, storage conditions, facilities and equipment, management level of inspection, to effectively ensure the quality of vaccines. () Carry out special inspection of imported ginseng. Starting with the inspection of port inspection reports and imported medicinal material approvals, we investigated and dealt with the behavior of counterfeit imported ginseng, and rectified the market of tonic medicines. () Strictly implement the examination methods of drug advertisements, jointly with the County Administration for Industry and Commerce to vigorously rectify false and illegal drug advertisements, investigate and deal with illegal drug advertisements in the name of patients, public figures, experts as proof of efficacy, and do a good job in related cases of violations. Transfer work (county industrial and commercial bureau, county food and drug administration is responsible for). () Strengthen the supervision of drug production enterprises, increase inspection efforts, and urge enterprises to organize production according to the legal standard production process to achieve material balance, deviation processing and the handling of substandard products in a timely manner. () to carry out the drug enterprise access management special,
County drug quality and safety special rectification action program
Item inspection. In accordance with the drug business quality management standard for drug wholesale enterprises, drug retail enterprises to carry out a comprehensive inspection, the failure to meet the requirements reported to the provincial and municipal Drug Administration to withdraw the "drug business license" according to law. (ii) Carrying out special inspections on the categorization and management of prescription drugs and non-prescription drugs. Investigate and deal with drug retail enterprises prescription drug purchase source, prescription drugs with prescription or registration sales; pharmacist on duty system implementation, prescription whether there are contraindications or overdose sales.
, medical
Instruments special rectification:
() to carry out special inspection of implantable medical devices. Check the use of implantable medical devices, whether the operating unit for the record, the use of units from the purchase, acceptance, use, tracking and inspection are recorded. Whether the establishment of medical device adverse monitoring records, whether the use of medical devices without product registration certificate. (）Focus on strengthening the quality control of high-risk products such as orthopedic implantable devices, contact lenses and hearing aids, as well as carrying out quality supervision and sampling tests for products of doubtful quality. Continue to urge medical institutions at all levels to establish and improve the use and management system of high-risk medical devices, and further standardize the procurement and use of high-risk medical devices and quality tracking and management. (ii) Carry out the monitoring of adverse drug reactions and adverse events of medical devices. Increase the monitoring of adverse drug reactions, adverse events of medical devices to publicize the work, popularize the adverse drug reactions, adverse events of medical devices to monitor the knowledge, correct understanding, scientific treatment of adverse drug reactions, adverse events of medical devices.
(B) the establishment of a sound long-term mechanism
, the establishment of a sound "medicine and equipment retailer points management approach" to promote corporate integrity and self-discipline. Establishment of a sound "drug retail enterprise points management approach", "drug retail enterprise star rating implementation measures" and "star drugstore rating standards. In addition to administrative penalties, the enterprises found to have violated the law in the supervision will also be given points for bad behavior, and based on the size of the points, the illegal and unruly behavior of the enterprises will be warned and punished through the record, media exposure, mandatory training, and the suggestion of cancellation of the designated pharmacies of the medical insurance. For the whole cumulative no points of the enterprise, priority recommended for the "three-star pharmacy" candidates. In this way to promote the pharmaceutical industry integrity system and self-regulatory mechanism, improve regulatory efficiency, and promote the continuous improvement of drug quality assurance level.
, deepen the standardization of pharmacy construction to protect the farmers with safe and effective medication. First, the refinement of service guidance. The first step is to make sure that you have a good understanding of how to use the Internet, and how to use the Internet in a way that will make it easier for you to access the Internet. At the same time to strengthen the supervision, inspection and guidance of rural medical institutions pharmacy, to promote the pharmacy really realize standardized management. Second, departmental collaboration to strengthen supervision. With the county health bureau jointly issued a "notice on further deepening the construction of standardized pharmacy" and "standardized pharmacy set standards" and other documents, the construction of standardized pharmacy into the health bureau of the degree of assessment of the medical institutions, the new village health office, individual clinics require the first through the standardized pharmacy acceptance, with the supervision of individual clinics, health care institutions, the standardization of pharmacy construction.
, the development of "Longyou County implantable medical device supervision and management of interim regulations" to strengthen the supervision of high-risk medical devices. The procurement of high-risk medical devices, the use of other aspects of the clear provisions: require medical institutions to do a good job of purchasing unit qualification audit, the request for documents, acceptance of the account records, adverse reactions to the tracking. Each medical institution has determined special personnel to implement the implementation of this provision. At the same time to strengthen the implantable medical device procurement and use of inspection, and require each medical institution's full-time or part-time medical device adverse event monitoring personnel, the use of implantable medical devices to track, timely detection, timely reporting.
Third, the work progress and time schedule
Drug remedial action in three stages.
(a) mobilization and deployment phase (month to month)
In-depth study and comprehension of the State Council leadership of the important instructions to unify ideological understanding, a clear guiding ideology, goals and objectives, focus on remediation and work tasks. The establishment of the organizational structure, a clear division of responsibilities, combined with the actual study and development of remedial action programs and special rectification plan. Through newspapers, radio, television and other media and organized columns, special interviews and other forms of publicity on product quality and food safety special rectification action, publicize the "Special Provisions" and the relevant drug regulatory laws and regulations, announced the complaint hotline, the formation of product quality and food safety work of society as a whole to pay attention to a wide range of positive support, with the participation of a good atmosphere.
County drug quality and safety special rectification action plan
(B) special rectification stage (month to month)
In the mobilization and deployment of the basis, in accordance with the "State Council on the strengthening of food and other product safety supervision and management of the Special Provisions," "the Office of the People's Government of Zhejiang Province on the further strengthening of the supervision and management of drug safety notification" (Zhejian government office [XX]), "Longyou County People's Government on the supervision of drug safety" (Zhejian government office [XX]). No. 1), "Longyou County People's Government Office on further strengthening the supervision of drug safety notice" and "Longyou County product quality and food safety special rectification action plan" spirit, highlighting the key points, comprehensive attack way, vigorously carry out drug rectification action.
month - month of the county drug market survey mapping
month - month of the county county hospitals to carry out special inspections
month - month of the township health centers to carry out special inspections
month -Months to conduct standardized pharmacy inspections and guidance for village health clinics throughout the county
Months to conduct special inspections of pharmaceutical wholesalers and operators throughout the county
(C) Summarize and improve the stage (month to month)
Analyze and summarize remediation work and carry out a "look back". "Look back" action, check for gaps, and months before the completion of the summary reported to the Office of the Bureau, the Office of the month before the county product quality and food safety special rectification work leading group. The drug special rectification action must be deployed with the State Council in last month to carry out half of the rectification and standardization of the drug market order special action as well as the Bureau of today's "style of construction, pay close attention to the implementation of the rural food and drug regulations," the activities of the combination, linkage, in a short period of time to focus on solving the outstanding problems affecting drug safety, to ensure that the special rectification work to achieve results. Rectification work to achieve tangible results.
Fourth, the work requirements
(a) Awareness-raising, strengthen leadership. Drug safety is related to the general public's health and safety of life, related to the image of the government and the country, related to the healthy development of the economy and social stability. Therefore, to carry out special rectification action of drugs and medical devices is of great significance. In order to ensure the smooth progress of this remedial action, to fight the special battle of this remedial action, under the unified leadership of the county government, in accordance with the "Longyou County Product Quality and Food Safety Special Remedial Action Program" general requirements, the establishment of the County Drug Administration, the County Health Bureau, the County Bureau of Quality Supervision, the County Bureau of Industry and Commerce, the County Board of Education, the County Public Security Bureau, and other departments and units as a member of the Longyou County Drug Safety Special Remedial Work Coordination Group by the County Pharmacovigilance Bureau Secretary Qian Xianfeng as head of the group, deputy director of the County Drug Administration Zhang Jinshou as deputy head of the relevant departments in charge of leadership as members of the work coordination group. Drug safety rectification work coordination group liaison section in the county office of the Drug Administration, contact number:, responsible for the daily contact, coordination and work of information reporting and other work.
(B) clear task, the implementation of responsibility.
County Food and Drug Administration to effectively strengthen the drug development, production, circulation, use of the whole process of supervision, according to the law to severely investigate and deal with a variety of illegal behavior. The county health bureau to strengthen the management of the hospital pharmacy, strictly require medical institutions to comply with the provisions of the quality management of drugs, the implementation of medical institutions on the drug terminal consumer safety responsibility. County Bureau of Industry and Commerce to severely investigate and deal with false and illegal drug advertisements, increase the crackdown, effectively curbing the phenomenon of repeated false and illegal drug advertisements, strict management of urban and rural market sales of Chinese herbal medicines. The county education bureau medicine requires school medical office effectively in accordance with the standardized pharmacy standards for the procurement, use and storage of drugs, education and guidance teachers and students to continuously enhance drug safety awareness. The relevant administrative and law enforcement departments to timely transfer to the public security organs suspected of criminal cases of production and sale of fake and shoddy drugs, the county public security organs to dig deeper into the production and sale of fake and shoddy drugs of the criminal network, increase the production and sale of fake and shoddy drugs of criminal activities of the crackdown. The publicity department should increase the drug safety publicity and education efforts to guide the news unit with the drug regulatory departments to do a good job of drug safety publicity work, and actively guide the majority of production and management enterprises to be honest and law-abiding, to improve the public's knowledge of drug safety and safety awareness, and to create a good public opinion environment for drug safety.
(C) strict law enforcement, strengthened.
To strictly in accordance with the "Special Provisions" and "Drug Administration Law" and other relevant laws, to fulfill the supervision and management responsibilities, to be open, fair and impartial, and strictly investigate and deal with the production and sale of non-compliance with the fake and shoddy medicines and equipment violations; to improve the mechanism of convergence between administrative law enforcement and the criminal justice, suspected of constituting a crime, and need to be investigated for criminal responsibility according to the provisions of the referral to the public security organs; on the major counterfeiting and sale of fake For major counterfeiting and counterfeiting violations and criminals with serious consequences, they should be severely punished in accordance with the law. We should insist on arresting major cases, intensifying the investigation and handling of cases, and implementing the "Four No Spares" and "Four Uniforms". The seriousness of the violation of the law, resolutely and severely punished according to law, the investigation and handling of major typical cases should be promptly announced the results of the investigation and handling, seriously dealt with the responsible person.
County drug quality and safety special rectification action program
(D) to strengthen coordination, close cooperation. To focus on the work of the special rectification goals and priorities, fully perform their functions, each in its own division, each responsible, to do what is forbidden, close cooperation, good convergence, the establishment of the upper and lower linkage, departmental linkage, regional linkage of the work mechanism, the formation of a tight regulatory network. In the county product quality and food safety leading group under the unified command of the group, the group, actively work on key drugs, key units, key areas and key issues, focusing on time, focusing on the force, and joint efforts to combat the investigation.
(E) to strengthen publicity, smooth information. In the process of remediation, strengthen the positive guidance, set up a drug manufacturer and operator for drug safety a sense of responsibility, so that operators consciously assume responsibility for drug safety, active cooperation, consciously participate in the remediation work. To actively seek the cooperation of news organizations, give full play to the press, radio, television, Internet and other media, vigorously publicize the results of the rectification. Typical cases and major cases to be exposed, the formation of social concern and participation in drug safety rectification of a favorable atmosphere. Timely product quality and food safety to the county product quality and food safety special action leading group and its offices to provide accurate, scientific information on drug safety, to achieve smooth information, consistent pace, to ensure that the special rectification work solid and steady progress.
According to the requirements of the higher level, in order to timely grasp the progress of this drug safety special rectification work, the implementation of special information reporting system. Specific reporting requirements are as follows: from the month, the County Food and Drug Administration comprehensive office summary by e-mail and in writing every week to the City Food and Drug Administration, the county product quality and food safety special action leading group office, to send the jurisdiction to carry out special rectification of the work of the work of the dynamics of the Longyue County drug safety special rectification action to investigate and deal with the situation weekly statement. Monthly report to Longyou County drug safety special rectification action work statement and summary;, the special rectification process occurs in the important situation, typical examples, at any time to report.