Adverse drug reaction report and monitoring management measures

 

 

 　　《The Measures for the Reporting and Monitoring of Adverse Drug Reactions was reviewed and approved by the Ministry of Health at the Ministry of Health on December 13, 2010. It is hereby promulgated and will be implemented as of July 1, 2011.

 

 

 

Minister Chen Hao

 

May 4, 2011

 

 

 

Adverse drug reaction report and monitoring management measures

 

 

Chapter 1 General

 

　　Article 1 In order to strengthen post-marketing supervision of drugs, standardize reports and monitoring of adverse drug reactions, timely and effectively control drug risks, and ensure the safety of public drug use, these measures are formulated in accordance with the relevant laws and regulations of the Drug Administration Law of the People's Republic of China.

 

Article 2 These Measures shall apply to the reporting, monitoring and supervision of adverse drug reactions within the territory of the People's Republic of China.

 

Article 3 The State implements a reporting system for adverse drug reactions. Pharmaceutical manufacturers (including overseas pharmaceutical manufacturers that import drugs), pharmaceutical companies, and medical institutions shall report the adverse drug reactions found in accordance with regulations.

 

Article 4 The State Food and Drug Administration is in charge of the national adverse drug reaction report and monitoring work, and the local drug supervision and administration departments at various levels are responsible for the reporting and monitoring of adverse drug reactions within their respective administrative regions. The health administrative departments at all levels are responsible for the management of medical institutions within their respective administrative areas and the implementation of the adverse drug reaction reporting system.

 

Local drug supervision and administration departments at all levels shall establish and improve monitoring institutions for adverse drug reactions, and be responsible for the technical work of reporting and monitoring adverse drug reactions within their respective administrative regions.

 

Article 5 The State encourages citizens, legal persons and other organizations to report adverse drug reactions.

 

Chapter II Responsibilities

 

Article 6 The State Food and Drug Administration is responsible for the management of national adverse drug reaction reports and monitoring, and performs the following main duties:

 

(1) Cooperating with the Ministry of Health to formulate management regulations and policies for adverse drug reaction reports and monitoring, and supervise their implementation;

 

(2) Jointly organizing, with the Ministry of Health, the investigation and handling of adverse events of drug groups that have a large impact on the whole country and causing serious consequences, and release relevant information;

 

(3) Taking emergency control measures against drugs that have confirmed serious adverse drug reactions or adverse events of drug groups, making administrative decisions and making them known to the public;

 

(4) to report the national adverse drug reaction report and monitoring;

 

(5) Organizing and inspecting the development of adverse drug reaction reports and monitoring work of pharmaceutical production and operation enterprises, and jointly organizing inspections with the Ministry of Health to check the development of adverse drug reaction reports and monitoring work of medical institutions.

 

Article 7 The drug supervision and administration department of a province, autonomous region or municipality directly under the Central Government shall be responsible for the management of adverse drug reaction reports and monitoring within its administrative region, and shall perform the following main duties:

 

(1) Cooperating with the health administrative department at the same level in accordance with these Measures to formulate management regulations for adverse drug reaction reports and monitoring in the administrative region, and supervise the implementation;

 

(2) Jointly organizing, with the health administrative department at the same level, the investigation and handling of adverse events of drug groups that have occurred in the administrative region, and releasing relevant information;

 

(3) Taking emergency control measures against drugs that have confirmed serious adverse drug reactions or adverse events of drug groups, making administrative decisions and making them known to the public;

 

(4) to report the reports and monitoring of adverse drug reactions in the administrative region;

 

(5) Organizing and inspecting the development of adverse drug reaction reports and monitoring work of pharmaceutical production and operation enterprises in the administrative region, and jointly organizing and inspecting the adverse drug reaction reports and monitoring work of medical institutions within the administrative region with the health administrative departments at the same level. Development situation;

 

(6) Organizing the publicity and training of reports and monitoring of adverse drug reactions in the administrative region.

 

    Article 8 The municipal and county-level drug supervision and administration departments of the district shall be responsible for the management of adverse drug reaction reports and monitoring within their respective administrative areas; and jointly organize the development of drug group adverse events within their respective administrative areas with the health administrative departments at the same level. Investigate and take necessary control measures; organize the promotion and training of adverse drug reaction reports and monitoring in the administrative region.

 

Article 9 The administrative department of health at or above the county level shall strengthen the supervision and administration of the clinical use of drugs in medical institutions, and take relevant emergency control measures in accordance with the law to the confirmed serious adverse drug reactions or adverse events of the drug groups.

 

Article 10 The National Center for Adverse Drug Reaction Monitoring is responsible for the technical work of the national adverse drug reaction report and monitoring, and performs the following main duties:

(1) To undertake the collection, evaluation, feedback and reporting of national adverse drug reaction reports and monitoring materials, as well as the construction and maintenance of the national drug adverse reaction monitoring information network;

(2) Formulating technical standards and norms for adverse drug reaction reports and monitoring, and providing technical guidance to local adverse drug reaction monitoring institutions at all levels;

(3) Organizing investigations and evaluations of serious adverse drug reactions, and assisting relevant departments to conduct investigations on adverse events of drug groups;

(4) issuing warning information for adverse drug reactions;

(5) To undertake the publicity, training, research and international exchange of adverse drug reaction reports and monitoring.

 

Article 11 The provincial drug adverse reaction monitoring agency is responsible for the technical work of adverse drug reaction reporting and monitoring within its administrative region, and performs the following main duties:

(1) To undertake the collection, evaluation, feedback and reporting of adverse drug reaction reports and monitoring data in the administrative region, and the maintenance and management of the information network for adverse drug reaction monitoring;

(2) Providing technical guidance to the municipal and county-level adverse drug reaction monitoring agencies in the district;

(3) Organizing the investigation and evaluation of serious adverse drug reactions in the administrative region, and assisting relevant departments to carry out investigations on adverse events of drug groups;

(4) Organizing the publicity and training of reports and monitoring of adverse drug reactions in the administrative region.

 

Article 12 The municipal and county-level adverse drug reaction monitoring agencies in the district shall be responsible for the collection, verification, evaluation, feedback and reporting of adverse drug reaction reports and monitoring data within their respective administrative regions; Investigation and evaluation; assist relevant departments to carry out investigations on adverse events of drug groups; undertake publicity and training of reports and monitoring of adverse drug reactions.

 

Article 13 Pharmaceutical production and operation enterprises and medical institutions shall establish reports and monitoring and management systems for adverse drug reactions. Pharmaceutical production enterprises shall set up specialized institutions and be equipped with full-time personnel. Pharmaceutical enterprises and medical institutions shall establish or appoint institutions and be equipped with special (part-time) personnel to undertake the reporting and monitoring of adverse drug reactions of their own units.

 

Article 14 Staff members engaged in the reporting and monitoring of adverse drug reactions shall have relevant professional knowledge in medicine, pharmacy, epidemiology or statistics, and have the ability to scientifically analyze and evaluate adverse drug reactions.

 

Chapter III Reporting and Disposal

 

Section 1 Basic requirements

 

Article 15: Pharmaceutical production and business enterprises and medical institutions that have obtained or discovered adverse reactions that may be related to drug use shall report through the National Adverse Drug Reaction Monitoring Information Network; if they do not have online reporting conditions, they shall report to the local drug through a paper report. The reaction monitoring agency shall report on-line by the local drug adverse reaction monitoring agency.

The content of the report should be true, complete and accurate.

 

Article 16 The monitoring agencies for adverse drug reactions at all levels shall evaluate and manage the adverse drug reaction reports and monitoring materials in their respective administrative regions.

 

Article 17 Pharmaceutical production and operation enterprises and medical institutions shall cooperate with the drug supervision and administration department, the health administrative department and the adverse drug reaction monitoring agency to investigate adverse drug reactions or group adverse events, and provide the information needed for the investigation.

 

Article 18 Pharmaceutical production and operation enterprises and medical institutions shall establish and maintain adverse drug reaction reports and monitoring files.

 

Section 2 Adverse Drug Reactions

 

Article 19 Pharmaceutical production and operation enterprises and medical institutions shall take the initiative to collect adverse drug reactions. After obtaining or discovering adverse drug reactions, they shall record, analyze and handle them in detail, and fill out the “Adverse Drug Reaction/Event Report Form” (see Attachment 1). And report.

 

Article 20 Domestically produced drugs during the monitoring period of new drugs shall report all adverse reactions of the drugs; other domestically produced drugs report new and serious adverse reactions.

The imported drug reports all adverse reactions of the imported drug within 5 years from the date of the first approved import; when it is 5 years old, it reports new and serious adverse reactions.

 

Article 21 Drug production, business enterprises and medical institutions shall discover or be informed of new and serious adverse drug reactions within 15 days, of which death cases shall be reported immediately; other adverse drug reactions shall be reported within 30 days. If there is follow-up information, it should be reported in time.

 

Article 22 A pharmaceutical production enterprise shall investigate the known death cases, and know in detail the basic information of the death cases, the use of the drugs, the occurrence of adverse reactions, and the diagnosis and treatment, and complete the investigation report within 15 days and report to the location of the pharmaceutical production enterprise. Provincial drug adverse reaction monitoring agency.

 

Article 23 Individuals who discover new or serious adverse drug reactions may report to the doctors who have been treated, or may report to the drug production and operation enterprises or the local drug adverse reaction monitoring agencies, and provide relevant medical records if necessary.

 

Article 24 The municipal and county-level adverse drug reaction monitoring agencies in the district shall review the authenticity, completeness and accuracy of the reported adverse drug reaction reports. The review and evaluation of serious adverse drug reaction reports shall be completed within 3 working days from the date of receipt of the report, and the review and evaluation of other reports shall be completed within 15 working days.

The municipal and county-level adverse drug reaction monitoring agencies in the district shall investigate the death cases, and learn in detail the basic information of the death cases, the use of the drugs, the occurrence of adverse reactions, and the diagnosis and treatment. 15 work from the date of receipt of the report. Complete the investigation report within the day, report to the drug regulatory department at the same level and the health administrative department, as well as the monitoring agency for adverse drug reactions at the higher level.

 

Article 25 The provincial-level adverse drug reaction monitoring agency shall complete the evaluation within 7 working days from the date of receiving the evaluation opinions on serious adverse drug reactions submitted by the next-level adverse drug reaction monitoring agency.

The provincial drug adverse reaction monitoring institutions for the death cases, the place where the incident occurred and the location of the pharmaceutical production enterprise shall timely analyze and evaluate according to the investigation report, conduct on-site investigation if necessary, and report the evaluation results to the provincial drug supervision and management department and health. Administration, as well as the National Center for Adverse Drug Reaction Monitoring.

 

Article 26 The National Center for Adverse Drug Reaction Monitoring shall analyze and evaluate the death cases in a timely manner, and report the evaluation results to the State Food and Drug Administration and the Ministry of Health.

 

Section III Drug Group Adverse Events

 

Article 27: Pharmaceutical production and operation enterprises and medical institutions shall immediately report to the county-level drug regulatory authority, the health administrative department and the adverse drug reaction monitoring agency by telephone or fax after they have been informed or discovered the adverse events of the drug group. If necessary, it can be reported at the same level; at the same time, fill out the "Basic Information Table for Adverse Events of Drug Groups" (see Attachment 2). For each case, the "Adverse Drug Reaction/Event Report Form" should be completed in time, and the National Adverse Drug Reaction Monitoring Information Network should be adopted. report.

 

Article 28 After obtaining the adverse events of the drug group, the municipal and county-level drug regulatory authorities of the district shall immediately organize a site investigation with the health administrative department at the same level, and report the results of the investigation to the provincial drugs in a timely manner. Supervise management and health administration.

The provincial drug supervision and management department and the health administrative department at the same level jointly supervise and guide the investigation of the municipal and county level of the district, analyze and evaluate the adverse events of the drug group, and have drugs that have a greater impact on the administrative region. In case of group adverse events, on-site investigations should also be organized. The evaluation and investigation results should be reported to the State Food and Drug Administration and the Ministry of Health in a timely manner.

The State Food and Drug Administration shall jointly carry out relevant investigations with the Ministry of Health for adverse events of drug groups that have a large impact on the whole country and cause serious consequences.

 

Article 29 A pharmaceutical production enterprise shall immediately investigate the adverse events of the drug group and learn more about the occurrence of adverse events of the drug group, the use of drugs, the diagnosis and treatment of patients, and the production, storage, circulation, and similar adverse events of the drug. Complete the investigation report within the day, report to the local provincial drug supervision and management department and the drug adverse reaction monitoring institution; at the same time, carry out self-examination quickly, analyze the cause of the incident, and suspend the production, sale, use and recall of relevant drugs when necessary, and report to the local province Level drug supervision and management department.

 

Article 30 A drug trading enterprise shall immediately notify the pharmaceutical production enterprise of the adverse event of the drug group, and shall promptly carry out self-inspection, and shall suspend the sales of the drug if necessary, and assist the pharmaceutical production enterprise to take relevant control measures.

 

Article 31 After discovering adverse events of drug groups, medical institutions shall actively treat patients, promptly carry out clinical investigations, analyze the causes of the occurrence of the accidents, and take emergency measures such as suspending the use of drugs if necessary.

 

Article 32 The drug regulatory authority may take control measures such as suspending production, sale, use or recall of drugs. The health administrative department shall take measures to actively organize the treatment of patients.

 

Section IV Serious Adverse Drug Reactions Occurred Abroad

 

Article 33: Serious adverse drug reactions (including those collected by spontaneous reporting systems, post-marketing clinical research, and reported in the literature) of imported drugs and domestically produced drugs, drug manufacturers should fill out "adverse drug reactions occurring outside the country" / Incident Report Form (see Attachment 3), submitted to the National Center for Adverse Drug Reaction Monitoring within 30 days from the date of notification. If the National Center for Adverse Drug Reaction Monitoring requests the original report and relevant information, the pharmaceutical production enterprise shall submit it within 5 days.

 

Article 34 The National Center for Adverse Drug Reaction Monitoring shall analyze and evaluate the reports of adverse drug reactions received, report to the State Food and Drug Administration and the Ministry of Health every six months, and shall promptly disclose information indicating that the drugs may have potential safety hazards. report.

 

Article 35 If imported drugs and domestically produced drugs are suspended from being sold, used or withdrawn from the market due to adverse drug reactions, the pharmaceutical production enterprises shall report to the State Food and Drug Administration and the national drug adverse reaction monitoring within 24 hours after being notified. center.

 

Section V Periodic Safety Update Report

 

Article 36 A pharmaceutical production enterprise shall conduct regular summary analysis of the adverse reaction reports and monitoring data of the pharmaceutical products produced by the enterprise, summarize domestic and international safety information, conduct risk and benefit assessment, and write periodic safety update reports. The writing guidelines for regular safety update reports are developed by the National Center for Adverse Drug Reactions.

 

Article 37 Domestically-produced drugs for the establishment of new drug monitoring period shall submit a periodic safety update report every one year from the date of obtaining the approval document, until the first re-registration, and then every five years; other domestically produced drugs, Reported every 5 years.

For drugs imported for the first time, a regular safety update report will be submitted every year after the date of obtaining the approval document for imported drugs, until the first re-registration, and then every 5 years.

   The summary time of the periodic safety update report is based on the date of obtaining the drug approval document, and the reporting date should be on the summary data deadline.