Article 2 These Measures shall apply to the reporting, monitoring, supervision and management of adverse drug reactions in People's Republic of China (PRC).
Article 3 The State practices a reporting system for adverse drug reactions. Pharmaceutical producing enterprises (including overseas pharmaceutical enterprises importing drugs), pharmaceutical trading enterprises and medical institutions shall report the adverse drug reactions found in accordance with the regulations.
Article 4 The State Food and Drug Administration of the United States shall be in charge of the reporting and monitoring of adverse drug reactions nationwide, and the local drug supervision and administration departments at all levels shall be in charge of the reporting and monitoring of adverse drug reactions within their respective administrative areas. Health administrative departments at all levels are responsible for the management of medical institutions related to the implementation of the adverse drug reaction reporting system within their respective administrative areas.
Local drug supervision and administration departments at all levels shall establish and improve the monitoring institutions for adverse drug reactions, and be responsible for the technical work of reporting and monitoring adverse drug reactions within their respective administrative areas.
Article 5 The State encourages citizens, legal persons and other organizations to report adverse drug reactions.
Chapter II Duties and Responsibilities
Article 6 The State Food and Drug Administration of the United States is responsible for the management of reporting and monitoring of adverse drug reactions nationwide, and performs the following main duties:
(1) To formulate, jointly with the Ministry of Health, management regulations and policies on reporting and monitoring of adverse drug reactions, and supervise their implementation;
(two) in conjunction with the Ministry of health to organize the investigation and handling of adverse events of drug groups with great influence and serious consequences nationwide, and release relevant information;
(3) Take emergency control measures for drugs that have been confirmed to have serious adverse drug reactions or adverse drug group incidents, make administrative treatment decisions, and announce them to the public;
(4) reporting and monitoring of adverse drug reactions nationwide;
(five) to organize the inspection of the reporting and monitoring of adverse drug reactions in pharmaceutical production and trading enterprises, and jointly organize the inspection of the reporting and monitoring of adverse drug reactions in medical institutions with the Ministry of Health.
Article 7 The pharmaceutical supervisory and administrative departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the reporting, monitoring and management of adverse drug reactions within their respective administrative areas, and perform the following main duties:
(a) according to these measures and the health administrative department at the same level * * * to formulate the administrative regulations on the reporting and monitoring of adverse drug reactions within their respective administrative areas, and supervise their implementation;
(two) in conjunction with the health administrative department at the same level, organize the investigation and handling of adverse events of drug groups with great influence within their respective administrative areas, and release relevant information;
(3) Take emergency control measures for drugs that have been confirmed to have serious adverse drug reactions or adverse drug group incidents, make administrative treatment decisions, and announce them to the public;
(4) Reporting and monitoring adverse drug reactions within their respective administrative areas;
(5) Organizing the inspection of the development of reporting and monitoring of adverse drug reactions of pharmaceutical production and trading enterprises within their respective administrative areas, and organizing the inspection of reporting and monitoring of adverse drug reactions of medical institutions within their respective administrative areas jointly with the health administrative department at the same level;
(six) to organize publicity and training on the reporting and monitoring of adverse drug reactions within their respective administrative areas.
Article 8 The drug supervision and administration departments at the city and county level divided into districts shall be responsible for the management of reporting and monitoring of adverse drug reactions within their respective administrative areas; Jointly organize and carry out the investigation of adverse drug group incidents within their respective administrative areas with the health administrative departments at the same level, and take necessary control measures; Organize publicity and training on reporting and monitoring of adverse drug reactions within their respective administrative areas.
Article 9 The health administrative department at or above the county level shall strengthen the supervision and management of clinical drug use in medical institutions, and take relevant emergency control measures for serious adverse drug reactions or adverse drug group incidents that have been diagnosed within the scope of their duties.
Article 10 The National Adverse Drug Reaction Monitoring Center is responsible for the technical work of national adverse drug reaction reporting and monitoring, and performs the following main duties:
(a) to undertake the collection, evaluation, feedback and submission of national adverse drug reaction reports and monitoring data, as well as the construction and maintenance of the national adverse drug reaction monitoring information network;
(2) Formulating technical standards and norms for reporting and monitoring adverse drug reactions, and providing technical guidance to local adverse drug reaction monitoring institutions at all levels;
(3) Organizing the investigation and evaluation of serious adverse drug reactions, and assisting relevant departments in the investigation of adverse drug group incidents;
(4) Issuing warning information on adverse drug reactions;
(five) to undertake the publicity, training, research and international exchange of adverse drug reaction reports and monitoring.
Eleventh provincial adverse drug reaction monitoring institutions shall be responsible for the technical work of reporting and monitoring adverse drug reactions within their respective administrative areas, and perform the following main duties:
(a) to undertake the collection, evaluation, feedback and submission of adverse drug reaction reports and monitoring data within their respective administrative areas, as well as the maintenance and management of the adverse drug reaction monitoring information network;
(two) to provide technical guidance to the city and county level adverse drug reaction monitoring institutions;
(3) Organizing the investigation and evaluation of serious adverse drug reactions within their respective administrative areas, and assisting relevant departments in investigating adverse drug group incidents;
(4) Organizing publicity and training on reporting and monitoring of adverse drug reactions within their respective administrative areas.
Twelfth districted municipal and county-level ADR monitoring institutions are responsible for the collection, verification, evaluation, feedback and reporting of ADR reports and monitoring data within their respective administrative areas; To carry out the investigation and evaluation of serious adverse drug reactions within their respective administrative areas; Assist relevant departments to carry out the investigation of adverse events of drug groups; To undertake the publicity and training of adverse drug reaction reporting and monitoring.
Thirteenth pharmaceutical production and marketing enterprises and medical institutions shall establish a reporting and monitoring system for adverse drug reactions. Pharmaceutical production enterprises shall set up specialized institutions and be equipped with full-time personnel, and pharmaceutical trading enterprises and medical institutions shall set up or designate institutions and be equipped with full-time (part-time) personnel to undertake the reporting and monitoring of adverse drug reactions in their own units.
Article 14 The staff engaged in reporting and monitoring adverse drug reactions shall have relevant professional knowledge such as medicine, pharmacy, epidemiology or statistics, and have the ability to scientifically analyze and evaluate adverse drug reactions.
Chapter III Reporting and Disposal
The first section basic requirements
Fifteenth pharmaceutical production and marketing enterprises and medical institutions shall report adverse reactions that may be related to drug use through the national adverse drug reaction monitoring information network; Do not have the online reporting conditions, it should be reported to the local adverse drug reaction monitoring institutions through paper reports, and the local adverse drug reaction monitoring institutions will report online.
The contents of the report shall be true, complete and accurate.
Sixteenth adverse drug reaction monitoring institutions at all levels shall evaluate and manage the adverse drug reaction reports and monitoring data within their respective administrative areas.
Article 17 pharmaceutical production and marketing enterprises and medical institutions shall cooperate with pharmaceutical supervisory and administrative departments, health administrative departments and adverse drug reaction monitoring institutions to investigate adverse drug reactions or group adverse events, and provide the information needed for the investigation.
Article 18 Pharmaceutical production and marketing enterprises and medical institutions shall establish and keep adverse drug reaction reports and monitoring files.
Section 2 Cases of Adverse Drug Reactions
Article 19 Pharmaceutical production and marketing enterprises and medical institutions shall actively collect adverse drug reactions, record, analyze and handle them in detail after understanding or finding them, fill in the report form of adverse drug reactions/incidents (see attached table 1) and report them.
Article 20 During the monitoring period of new drugs, all adverse reactions of domestic drugs shall be reported; Other domestic drugs reported new serious adverse reactions.
Report all adverse reactions of imported drugs within 5 years from the date of first allowing import; Five years later, new serious adverse reactions were reported.
Twenty-first pharmaceutical production and marketing enterprises and medical institutions shall report new and serious adverse drug reactions within 15 days, and death cases shall be reported immediately; Other adverse drug reactions should be reported within 30 days. Follow-up information shall be reported in a timely manner.
Article 22 A pharmaceutical production enterprise shall investigate the known death cases, know the basic information, drug use, occurrence of adverse reactions, diagnosis and treatment of the death cases in detail, complete the investigation report within 15 days, and report it to the provincial adverse drug reaction monitoring institution where the pharmaceutical production enterprise is located.
Article 23 If an individual discovers a new or serious adverse drug reaction, he may report it to the attending physician, or to the drug production and marketing enterprise or the local adverse drug reaction monitoring institution, and provide relevant medical records when necessary.
Twenty-fourth districts of the city and county-level ADR monitoring institutions shall review the authenticity, completeness and accuracy of the received ADR reports. The review and evaluation of serious adverse drug reaction reports shall be completed within 3 working days from the date of receiving the reports, and the review and evaluation of other reports shall be completed within 15 working days.
The municipal and county-level ADR monitoring institutions with districts shall investigate the death cases and learn more about the basic situation, drug use, occurrence, diagnosis and treatment of the death cases. , complete the investigation report within 15 working days from the date of receiving the report, and report it to the drug supervision and administration department at the same level, the health administrative department and the adverse drug reaction monitoring institution at the next higher level.
Twenty-fifth provincial adverse drug reaction monitoring institutions shall complete the evaluation work within 7 working days from the date of receiving the evaluation opinions of serious adverse drug reactions submitted by the next level adverse drug reaction monitoring institutions.
For death cases, provincial-level ADR monitoring institutions at the place where the incident occurred and where the pharmaceutical production enterprise is located shall make timely analysis and evaluation according to the investigation report, conduct on-site investigation when necessary, and report the evaluation results to provincial-level pharmaceutical supervisory and administrative departments, health administrative departments and national ADR monitoring center.
Article 26 The National Adverse Drug Reaction Monitoring Center shall analyze and evaluate the death cases in time and report the evaluation results to the US Food and Drug Administration and the Ministry of Health.
Section III Adverse Events of Drug Group
Article 27 pharmaceutical production and marketing enterprises and medical institutions shall immediately report to the local county-level pharmaceutical supervisory and administrative departments, health administrative departments and adverse drug reaction monitoring institutions by telephone, fax, etc. after learning or discovering the group adverse drug events of pharmaceuticals, and may skip the level when necessary; At the same time, fill in the Basic Information Form of Adverse Drug Events (see Annex 2), and fill in the Adverse Drug Reaction/Event Report Form in time for each case, and report it through the National Adverse Drug Reaction Monitoring Information Network.
Article 28 Upon learning of the adverse events of drug groups, the pharmaceutical supervisory and administrative departments at the city or county level divided into districts shall immediately organize on-site investigation together with the health administrative departments at the same level, and report the investigation results to the provincial pharmaceutical supervisory and administrative departments and the health administrative departments step by step in time.
The provincial drug supervision and administration department and the health administrative department at the same level jointly supervise and guide the investigation at the city and county levels, analyze and evaluate the adverse drug group incidents, and organize on-site investigations on the adverse drug group incidents that have great influence within their respective administrative areas. The evaluation and investigation results shall be reported to the State Food and Drug Administration and the Ministry of Health in a timely manner.
The State Food and Drug Administration and the Ministry of Health will carry out relevant investigations on adverse drug group events that have great influence and serious consequences throughout the country.
Article 29 After learning about the adverse events of drug groups, pharmaceutical production enterprises shall immediately carry out investigations to learn more about the occurrence, drug use, patient diagnosis and treatment, drug production, storage, circulation and similar adverse events in the past, and complete the investigation report within 7 days and report it to the local provincial drug supervision and administration department and the adverse drug reaction monitoring institution; At the same time, it is necessary to conduct self-examination quickly and analyze the cause of the incident. When necessary, the production, sale, use and recall of related drugs shall be suspended and reported to the local provincial drug supervision and administration department.
Article 30 When a pharmaceutical trading enterprise discovers an adverse drug group event, it shall immediately notify the pharmaceutical production enterprise, and at the same time, carry out self-examination quickly, suspend drug sales when necessary, and assist the pharmaceutical production enterprise to take relevant control measures.
Article 31 After discovering the adverse events of drug groups, medical institutions should actively treat patients, conduct clinical investigations quickly, analyze the causes of the events, and take emergency measures such as stopping medication when necessary.
Article 32 The pharmaceutical supervisory and administrative department may take control measures such as suspending the production, sale, use and recall of drugs. The administrative department of health shall take measures to actively organize the treatment of patients.