Article 1 In order to strengthen the safety monitoring of drug high-risk varieties of drug manufacturers and users in our region, further establish and improve the long-term monitoring mechanism from supervision to monitoring, from monitoring to early warning, from early warning to risk control, and effectively reduce drug safety risks, these measures are formulated in combination with the actual situation in our region.
Article 2 The Autonomous Region Adverse Drug Reaction Monitoring Center shall be responsible for the operational guidance of monitoring high-risk drug varieties in the whole region. Food and drug administrations at all levels are responsible for the guidance, supervision and management of key monitoring of high-risk varieties within their respective jurisdictions. Drug production enterprises are the first responsible person for drug monitoring, so the follow-up monitoring of enterprise products should be strengthened. Drug users should strengthen the management and monitoring of clinical rational use of high-risk drugs to ensure the safety of people's medication.
Article 3 These Measures shall apply to drug production (including API production), users, adverse drug reaction monitoring institutions, food and drug supervision and management departments at all levels and other relevant departments in Ningxia. Responsibilities and procedures
Article 4 The quarterly summary report system shall be implemented for high-risk key monitoring varieties. Drug production enterprises should focus on tracking and monitoring the high-risk drugs they produce, and summarize the monitoring situation of key monitoring varieties every quarter before the first month of next quarter 10, and report them to the autonomous region adverse drug reaction monitoring center in the form of official documents and electronic versions. Drug users should analyze and summarize the monitoring cases of key varieties and report them to the ADR monitoring center of the autonomous region through the network.
Article 5 Pharmaceutical production enterprises shall combine the quality risk management of high-risk varieties with key safety monitoring work and quality authorized person system, strengthen the sense of responsibility, actively carry out monitoring work, strengthen risk management, and prevent major pharmaceutical accidents.
Article 6 Pharmaceutical production enterprises shall establish and improve the scientific management mechanism for internal high-risk variety monitoring and the technical information base for adverse reaction monitoring, so as to improve the early warning ability and risk control ability of high-risk varieties. Through tracking and monitoring, we can fully grasp the safety risk signal of drug production in time, reduce the safety risk of high-risk varieties and ensure the safety of local drug use.
Article 7 A pharmaceutical production enterprise shall establish and improve an internal monitoring team and monitoring network system based on drug sales outlets, organically combine monitoring information with product sales, realize information resource sharing, and promote the institutionalization and standardization of monitoring work.
Article 8 A pharmaceutical production enterprise shall include the high-risk varieties it produces in the key management catalogue, carry out key tracking and monitoring, and report the key monitoring catalogue to the Food and Drug Administration of the autonomous region and the Adverse Drug Reaction Monitoring Center for the record.
Article 9 Medical institutions shall follow the principles of clinical rational drug use and prescription management measures, reduce intravenous drug use, strictly control the mixed intravenous drug use of traditional Chinese medicine injections and chemicals, and especially strengthen the monitoring of serious adverse reactions caused by clinical use of high-risk drugs.
Tenth Autonomous Region Adverse Drug Reaction Monitoring Center, through the electronic network and safe drug use information newsletter and other forms, timely release of drug warning information, to promote clinical safe and rational drug use.
Eleventh food and drug administrations at all levels should strengthen the key monitoring of high-risk drugs within their jurisdiction. Combine drug safety supervision and adverse reaction monitoring organically, identify the weak points of risk management monitoring and the breakthrough of promoting work, strengthen the risk early warning of key monitoring of high-risk varieties in the jurisdiction, and prevent major drug safety incidents.
Article 12 Food and Drug Administration at all levels shall take the national project of adverse drug reaction monitoring network informatization construction in cities and counties as an opportunity to strengthen the construction of regional monitoring network, realize the regional informatization of medical device monitoring, and use modern information technology to timely and comprehensively grasp the monitoring trends of risk management in the jurisdiction. Establish a "four early" monitoring and early warning mechanism for early prevention, early detection, early reporting and early control.
Thirteenth autonomous region adverse drug reaction monitoring center and drug production enterprises to establish a joint meeting system, regular or irregular joint meetings. The cities and counties (districts) of the US Food and Drug Administration shall establish a regular meeting system with production enterprises and medical institutions to strengthen risk monitoring management and guide risk monitoring.
Article 14 A pharmaceutical production enterprise (including raw materials) shall immediately report to the local pharmaceutical supervisory and administrative department the serious or sudden group adverse reactions occurring in the sales and use of drugs in accordance with the principle of step-by-step reporting. The local drug regulatory authorities shall promptly report to the food and drug administration of the autonomous region and the monitoring center for adverse drug reactions of the autonomous region, which shall report to the national monitoring center after being approved by the food and drug administration of the autonomous region.
Article 15 The investigation and handling of serious death cases and sudden group adverse reactions shall be the responsibility of the Food and Drug Administration in the place where the incident occurred at the first time. If it is initially confirmed as an adverse drug reaction event, it can be reported to the autonomous region monitoring center through the network, and the autonomous region monitoring center will promptly organize technical personnel to conduct on-site investigation and verification under the direct leadership of the regional bureau.
Sixteenth major and difficult cases, directly led by the food and drug administration of the autonomous region, organized a medical device monitoring technology expert consultation meeting, qualitative, put forward opinions.
Article 17 According to the Measures for the Administration of Adverse Drug Reactions Monitoring and Reporting, the autonomous region monitoring center can report serious cases of adverse drug reactions to the national monitoring center through online reporting procedures, and submit them to the autonomous region food and drug administration and the autonomous region health department in writing.
Eighteenth pharmaceutical production enterprises (including raw materials), the use of units, do not perform their supervisory duties and cause serious consequences, bear the corresponding legal responsibilities, and in accordance with the provisions of the integrity of the building. supplementary terms
Nineteenth approach by the autonomous region food and drug administration is responsible for the interpretation of.
Twentieth these Measures shall be implemented 30 days after the date of promulgation.
Attachment: 1 Some high-risk chemical injections
2. Some injection varieties have serious adverse reactions.