Measures for the Administration of Adverse Drug Reaction Reporting and Monitoring

 

 

 

The Administrative Measures for the Reporting and Monitoring of Adverse Drug Reactions, which were adopted at the ministerial meeting of the Ministry of Health on December 13, 2010, are hereby promulgated and shall come into force as of July 1, 2011.

 

 

 

Minister Chen Zhu
May 4, 2011

 

 

 

Measures for the Administration of Adverse Drug Reaction Reporting and Monitoring
Chapter I General Provisions

 

 

Chapter II Responsibilities

 

Article 6 The State Food and Drug Administration is responsible for the management of adverse drug reaction reports and monitoring nationwide, and performs the following main duties:
（1） Work with the Ministry of Health to formulate management regulations and policies for adverse drug reaction reporting and monitoring, and supervise their implementation;
（2） Jointly organize with the Ministry of Health to carry out nationwide investigation and handling of adverse events of drug groups with great impact and serious consequences, and release relevant information;
（3） Take emergency control measures for drugs that have been confirmed to have serious adverse drug reactions or adverse events of drug groups, make administrative decisions, and publicize them to the public;
（4） Inform the adverse drug reaction report and monitoring throughout the country;
（5） Organize the inspection of adverse drug reaction reports and monitoring of drug production and marketing enterprises, and jointly organize the inspection of adverse drug reaction reports and monitoring of medical institutions with the Ministry of Health.
Article 7 The drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the management of adverse drug reaction reports and monitoring within their respective administrative areas, and shall perform the following main duties:
（1） In accordance with these Measures, we will work with the health administration department at the same level to formulate the administrative provisions for the reporting and monitoring of adverse drug reactions within our administrative region, and supervise their implementation;
（2） Jointly organize the investigation and handling of adverse events of drug groups with large impact in the administrative region with the health administration department at the same level, and release relevant information;
（3） Take emergency control measures for drugs that have been confirmed to have serious adverse drug reactions or adverse events of drug groups, make administrative decisions, and publicize them to the public;
（4） Inform the adverse drug reaction report and monitoring within the administrative region;
（5） Organize the inspection of the adverse drug reaction reports and monitoring of drug production and trading enterprises in their respective administrative regions, and jointly organize the inspection of the adverse drug reaction reports and monitoring of medical institutions in their respective administrative regions with the health administrative departments at the same level;
（6） Organize the publicity and training of ADR reports and monitoring within their respective administrative regions.
Article 8 The drug regulatory departments at the level of cities divided into districts and at the county level shall be responsible for the administration of adverse drug reaction reports and monitoring within their respective administrative areas; To jointly organize and carry out the investigation of adverse events of drug groups in their respective administrative regions with the health administrative departments at the same level, and take necessary control measures; Organize the publicity and training of ADR reports and monitoring within their respective administrative regions.
Article 9 The health administrative departments at or above the county level shall strengthen the supervision and administration of clinical drug use in medical institutions, and take relevant emergency control measures for the confirmed serious adverse drug reactions or adverse drug events of drug groups within the scope of their duties.
Article 10 The National ADR Monitoring Center shall be responsible for the technical work of ADR reporting and monitoring nationwide, and shall perform the following main duties:
（1） Undertake the collection, evaluation, feedback and reporting of national ADR reports and monitoring data, as well as the construction and maintenance of the national ADR monitoring information network;
（2） Formulate technical standards and specifications for adverse drug reaction reporting and monitoring, and provide technical guidance to local adverse drug reaction monitoring institutions at all levels;
（3） Organize the investigation and evaluation of serious adverse drug reactions, and assist relevant departments in investigating adverse drug events of drug groups;
（4） Release adverse drug reaction warning information;
（5） Undertake the publicity, training, research and international exchange of adverse drug reaction reports and monitoring.
Article 11 The provincial ADR monitoring institutions shall be responsible for the technical work of ADR reporting and monitoring within their respective administrative regions, and shall perform the following main duties:
（1） To be responsible for the collection, evaluation, feedback and reporting of adverse drug reaction reports and monitoring data within the administrative region, as well as the maintenance and management of adverse drug reaction monitoring information network;
（2） Provide technical guidance to ADR monitoring institutions at the municipal and county levels;
（3） Organize the investigation and evaluation of serious adverse drug reactions within their respective administrative regions, and assist relevant departments in investigating adverse drug events of drug groups;
（4） Organize the publicity and training of ADR reports and monitoring within their respective administrative regions.
Article 12 The ADR monitoring institutions at the municipal and county levels divided into districts shall be 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 in their respective administrative regions; Assist relevant departments in investigating adverse events of drug groups; Undertake the publicity and training of adverse drug reaction report and monitoring.
Article 13 Pharmaceutical producing and trading enterprises and medical institutions shall establish a system for reporting and monitoring adverse drug reactions. Pharmaceutical producing enterprises shall set up special organizations with full-time personnel, pharmaceutical trading enterprises and medical institutions shall set up or designate organizations with full-time (part-time) personnel to undertake the reporting and monitoring of adverse drug reactions of their own units.
Article 14 The staff engaged in the reporting and monitoring of adverse drug reactions shall have the relevant professional knowledge of medicine, pharmacy, epidemiology or statistics, and the ability to scientifically analyze and evaluate adverse drug reactions.

 

Chapter III Report and Disposal

 

Section I Basic Requirements
Article 15 Pharmaceutical producing and trading enterprises and medical institutions shall report through the national adverse drug reaction monitoring information network when they know or find adverse drug reactions that may be related to drug use; If the conditions for online reporting are not met, it shall be reported to the local ADR monitoring institution through a paper report, and the local ADR monitoring institution shall report online on its behalf.
The report shall be true, complete and accurate.
Article 16 ADR monitoring institutions at all levels shall evaluate and manage ADR reports and monitoring data within their respective administrative regions.
Article 17 Pharmaceutical producing and trading enterprises and medical institutions shall cooperate with pharmaceutical supervisory and administrative departments, health administrative departments and adverse drug reaction monitoring institutions in the investigation of adverse drug reactions or group adverse events, and provide the materials needed for the investigation.
Article 18 Pharmaceutical producing and trading enterprises and medical institutions shall establish and keep adverse drug reaction reports and monitoring archives.
Section II Individual Adverse Drug Reactions
Article 19 Pharmaceutical producing and trading enterprises and medical institutions shall take the initiative to collect adverse drug reactions, make detailed records, analyze and deal with adverse drug reactions when they are known or found, fill in the Adverse Drug Reaction/Event Report Form (see Schedule 1) and report.
Article 20 All adverse reactions of domestic drugs during the monitoring period of new drugs shall be reported; For other domestic drugs, new and serious adverse reactions shall be reported.
Report all adverse reactions of the imported drugs within 5 years from the date when the imported drugs are first approved for import; After 5 years, new and serious adverse reactions are reported.
Article 21 Pharmaceutical producing and trading enterprises and medical institutions shall report new and serious adverse drug reactions found or known to them within 15 days, and the dead cases shall be reported immediately; Other adverse drug reactions shall be reported within 30 days. If there is follow-up information, it shall be reported in a timely manner.
Article 22 Pharmaceutical producing enterprises shall investigate the known cases of death, get a detailed understanding of the basic information of the cases of death, the use of drugs, the occurrence of adverse reactions, the diagnosis and treatment, etc., and complete the investigation report within 15 days, which shall be submitted to the provincial ADR monitoring institution where the pharmaceutical producing enterprises are located.
Article 23 When an individual discovers a new or serious adverse drug reaction, he or she may report it to the physician receiving treatment, or to the drug production or trade enterprise or the local adverse drug reaction monitoring institution, and provide relevant medical records when necessary.
Article 24 ADR monitoring institutions at the level of cities and counties divided into districts shall examine the authenticity, completeness and accuracy of ADR reports received. The review and evaluation of the serious adverse drug reaction report shall be completed within 3 working days from the date of receiving the report, and the review and evaluation of other reports shall be completed within 15 working days.
Adverse drug reaction monitoring institutions at the level of cities and counties divided into districts shall investigate the dead cases, get a detailed understanding of the basic information of the dead cases, drug use, adverse reaction occurrence, diagnosis and treatment, etc., complete the investigation report within 15 working days from the date of receiving the report, and report it to the drug regulatory department at the same level, the health administrative department, and the adverse drug reaction monitoring institutions at the next higher level.
Article 25 The provincial ADR monitoring institution shall complete the evaluation within 7 working days from the date of receiving the evaluation opinions on serious ADRs submitted by the next level ADR monitoring institution.
As for the death cases, the provincial ADR monitoring institutions in the place where the incident occurred and the drug manufacturer is located shall timely analyze and evaluate according to the investigation report, conduct on-site investigation when necessary, and report the evaluation results to the provincial drug regulatory department, the health administrative department, and the National ADR Monitoring Center.
Article 26 The SDADR Monitoring Center shall timely analyze and evaluate the death cases, and report the evaluation results to the State Food and Drug Administration and the Ministry of Health.
Section III Adverse events of drug group
Article 27 Pharmaceutical producing and trading enterprises and medical institutions shall immediately report to the local drug regulatory department at the county level, the administrative department of health and the adverse drug reaction monitoring institution by telephone or fax when they know or find the adverse events of pharmaceutical groups, and may skip the level when necessary; At the same time, fill in the Basic Information Form of Drug Group Adverse Events (see Attached Table 2), and fill in the Adverse Drug Reaction/Event Report Form for each case in time, and report through the national adverse drug reaction monitoring information network.
Article 28 After being informed of adverse events of drug groups, the drug regulatory departments at the level of cities divided into districts and at the county level shall immediately organize an on-site investigation with the health administrative departments at the same level, and report the investigation results to the drug regulatory departments at the provincial level and the health administrative departments level by level in a timely manner.
The provincial drug regulatory department and the health administrative department at the same level shall jointly supervise and guide the investigation of the cities and counties divided into districts, analyze and evaluate the adverse events of drug groups, and organize the on-site investigation of the adverse events of drug groups that have a greater impact in their own 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 shall jointly carry out relevant investigations with the Ministry of Health on adverse events of drug groups that have a great impact nationwide and cause serious consequences.
Article 29 When a drug manufacturer is informed of a drug group adverse event, it shall immediately carry out an investigation to find out in detail the occurrence of the drug group adverse event, the use of drugs, the diagnosis and treatment of patients, as well as the production, storage, circulation and previous similar adverse events of drugs, and complete the investigation report within 7 days and report it to the local provincial drug regulatory department and the drug adverse reaction monitoring institution; At the same time, self inspection shall be carried out rapidly to analyze the cause of the incident. If necessary, production, sales, use and recall of relevant drugs shall be suspended and reported to the local provincial drug regulatory department.
Article 30 When a drug handling enterprise discovers an adverse event involving a drug group, it shall immediately notify the drug producing enterprise, and at the same time, it shall promptly carry out self-examination. When necessary, it shall suspend the sale of drugs, and assist the drug producing enterprise in taking 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 events, and take emergency measures such as suspending the use of drugs when necessary.
Article 32 Pharmaceutical supervisory and administrative departments may take control measures such as suspension of production, sale, use or recall of pharmaceuticals. The administrative department of public health shall take measures to actively organize the treatment of patients.
Section 4 Serious Adverse Drug Reactions Abroad
Article 33 For serious adverse drug reactions (including those collected by the spontaneous reporting system, those found in post marketing clinical studies, and those reported in literature) of imported drugs and domestic drugs occurring abroad, drug manufacturers shall fill in the Report Form of Adverse Drug Reactions/Events Occurred Abroad (see Attached Table 3), and submit it to the National Center for Adverse Drug Reaction Monitoring within 30 days from the date of being informed. If the National Adverse Drug Reaction Monitoring Center requires to provide the original statement and relevant information, the drug manufacturer shall submit it within 5 days.
Article 34 The SDAC 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 report in a timely manner any information that indicates that drugs may have potential safety hazards.
Article 35 Where the sale, use or withdrawal of imported drugs and domestic drugs from the market is suspended due to adverse drug reactions abroad, the drug manufacturer shall report in writing to the State Food and Drug Administration and the National Center for Adverse Drug Reaction Monitoring within 24 hours after being informed.

 

Section V Regular Security Update Report

 

Article 36 A drug producing enterprise shall regularly summarize and analyze the adverse reaction reports and monitoring data of its drugs, summarize the safety information at home and abroad, evaluate the risks and benefits, and write regular safety update reports. The National Adverse Drug Reaction Monitoring Center shall be responsible for formulating the standard for writing regular safety update reports.
Article 37 For domestic drugs with a new drug monitoring and testing period, a regular safety update report shall be submitted every one year from the date of obtaining the approval certificate until the first re registration, and then every five years; Other domestic drugs shall be reported every 5 years.
For drugs imported for the first time, a regular safety update report shall be submitted every year since the date of obtaining the approval certificate for imported drugs, until the first re registration, and then every five years.
The summary time of the regular safety update report shall start from the date of obtaining the drug approval certificate, and the reporting date shall be within 60 days after the deadline for summarizing data.
Article 38 The regular safety update report of domestic drugs shall be submitted to the provincial ADR monitoring institution where the drug manufacturer is located. The regular safety update report of imported drugs (including imported sub packaged drugs) shall be submitted to the National Adverse Drug Reaction Monitoring Center.
Article 39 The provincial ADR monitoring institution shall summarize, analyze and evaluate the regular safety update reports it receives, and report the statistics and analysis results of the regular safety update reports of the previous year to the provincial drug regulatory department and the National ADR Monitoring Center before April 1 of each year.
Article 40 The SDADR Monitoring Center shall summarize, analyze and evaluate the regular safety update reports received, and report the statistics and analysis evaluation results of the regular safety update reports of domestic drugs and imported drugs of the previous year to the State Food and Drug Administration and the Ministry of Health before July 1 of each year.

 

Chapter IV Key Drug Monitoring

 

Article 41 Pharmaceutical producing enterprises shall regularly inspect the safety of the pharmaceuticals produced by their own enterprises, focus on the monitoring of pharmaceuticals within the monitoring period of new pharmaceuticals and pharmaceuticals imported for the first time within five years, and summarize, analyze, evaluate and report the monitoring data as required; Other drugs produced by the enterprise shall be actively monitored according to the safety situation.
Article 42 Pharmaceutical supervisory and administrative departments at or above the provincial level may, according to the clinical use of drugs and the monitoring of adverse reactions, require pharmaceutical manufacturers to focus on monitoring specific drugs; When necessary, it may also directly organize adverse drug reaction monitoring institutions, medical institutions and scientific research institutions to carry out key drug monitoring.
Article 43 Adverse drug reaction monitoring institutions at or above the provincial level shall be responsible for the supervision and inspection of the key monitoring conducted by drug manufacturers, and the technical evaluation of the monitoring reports.
Article 44 Pharmaceutical supervisory and administrative departments at or above the provincial level may, in conjunction with the health administrative departments at the same level, designate medical institutions as monitoring points to undertake key drug monitoring.

 

Chapter V Evaluation and Control

 

Article 45 Pharmaceutical producing enterprises shall analyze and evaluate the adverse drug reaction reports and monitoring data collected, and take the initiative to carry out research on drug safety.
Pharmaceutical manufacturers shall promptly inform medical personnel, patients and the public of adverse drug reactions and rational drug use information of drugs that have been confirmed to have serious adverse reactions through various effective ways; Take measures such as modifying labels and instructions, suspending production, sales, use and recall to reduce and prevent the recurrence of adverse drug reactions. For drugs with large adverse reactions, the approval documents shall be cancelled.
The drug manufacturer shall report the drug safety information and the measures taken to the local provincial drug regulatory department and the State Food and Drug Administration.
Article 46 Pharmaceutical trading enterprises and medical institutions shall analyze and evaluate the adverse drug reaction reports and monitoring data collected, and take effective measures to reduce and prevent the recurrence of adverse drug reactions.
Article 47 The provincial ADR monitoring institution shall conduct a comprehensive analysis of the ADR reports received every quarter, extract the safety information that needs attention, make an evaluation, put forward risk management suggestions, and report to the provincial drug regulatory department, the health administrative department, and the National ADR Monitoring Center in a timely manner.
The provincial drug regulatory department may, based on the analysis and evaluation results, take measures to suspend the production, sale, use and recall of drugs, supervise and inspect them, and notify the health administrative department at the same level of the measures taken.
Article 48 The SDADR Monitoring Center shall conduct a comprehensive analysis of the reports of serious adverse drug reactions received quarterly, extract the safety information that needs attention, evaluate them, and put forward risk management suggestions, which shall be reported to the State Food and Drug Administration and the Ministry of Health in a timely manner.
Article 49 The State Food and Drug Administration may, according to the results of drug analysis and evaluation, require enterprises to conduct research on drug safety and effectiveness. When necessary, it shall take measures such as ordering the modification of the drug description, suspending the production, sale, use and recall of drugs. For drugs with large adverse reactions, the drug approval certificate shall be revoked, and the relevant measures shall be reported to the Ministry of Health in a timely manner.
Article 50 Adverse drug reaction monitoring institutions at or above the provincial level may, according to the needs of the analysis and evaluation work, request drug producing and trading enterprises and medical institutions to provide relevant information, and the relevant units shall actively cooperate.

 

Chapter VI Information Management

 

Article 51 ADR monitoring institutions at all levels shall make statistics and analysis of ADR reports and monitoring data received, and give feedback in an appropriate form.
Article 52 The SDAC shall, based on the comprehensive analysis and evaluation results of the ADR reports and monitoring data, promptly publish the warning information of ADR.
Article 53 Pharmaceutical supervisory and administrative departments at or above the provincial level shall regularly publish reports on adverse drug reactions and monitoring information.
Article 54 The following information shall be uniformly released by the State Food and Drug Administration and the Ministry of Health:
（1） Adverse events of drug group with great impact and serious consequences;
（2） Other important adverse drug reaction information and information that needs to be published uniformly.
The State Food and Drug Administration and the Ministry of Health may also authorize provincial drug regulatory departments and health administrative departments to publish the information uniformly prescribed in the preceding paragraph.
Article 55 Trade secrets, personal privacy, patient and reporter information obtained in the process of adverse drug reaction reporting and monitoring shall be kept confidential.
Article 56 Medical institutions, drug producing enterprises and drug handling enterprises are encouraged to share adverse drug reaction information.
Article 57 The contents and statistical data of ADR reports are the basis for strengthening drug supervision and administration and guiding rational drug use.

 

Chapter VII Legal Liabilities

 

Article 58 In any of the following circumstances, the local drug regulatory department shall give a warning, order it to make corrections within a time limit, and may also impose a fine of not less than 5000 yuan but not more than 30000 yuan:
（1） Failing to establish an adverse drug reaction reporting and monitoring management system in accordance with the provisions, or having no special organization or full-time personnel responsible for the reporting and monitoring of adverse drug reactions in their own units;
（2） Failing to establish and maintain adverse drug reaction monitoring files;
（3） Failing to report, investigate, evaluate and handle adverse drug reactions or group adverse events as required;
（4） Failing to submit regular security update report as required;
（5） Failing to carry out key monitoring as required;
（6） Failing to cooperate in the investigation of serious adverse drug reactions or group adverse events;
（7） Other violations of these Measures.
If a drug producing enterprise falls under any of the circumstances specified in Items (4) and (5) of the preceding paragraph, it shall not re register the corresponding drugs in accordance with the provisions of the Measures for the Administration of Drug Registration.
Article 59 Where a drug handling enterprise is under any of the following circumstances, the local drug regulatory department shall give it a warning and order it to rectify within a time limit; If it fails to do so within the time limit, it shall be fined not more than 30000 yuan:
（1） There is no full-time or part-time person responsible for the monitoring of adverse drug reactions in the unit;
（2） Failing to report, investigate, evaluate and handle adverse drug reactions or group adverse events as required;
（3） Failing to cooperate in the investigation of serious adverse drug reactions or group adverse events.
Article 60 If a medical institution is under any of the following circumstances, the local health administrative department shall give it a warning and order it to make corrections within a time limit; If it fails to do so within the time limit, it shall be fined not more than 30,000 yuan. If the circumstances are serious and cause serious consequences, the local health administrative department shall give administrative sanctions to the relevant responsible person:
（1） There is no full-time or part-time person responsible for the monitoring of adverse drug reactions in the unit;
（2） Failing to report, investigate, evaluate and handle adverse drug reactions or group adverse events as required;
（3） Failing to cooperate in the investigation of serious adverse drug reactions and group adverse events.
If a drug regulatory department finds that a medical institution has committed any of the acts specified in the preceding paragraph, it shall transfer the matter to the health administrative department at the same level for handling.
If the health administrative department decides to impose an administrative penalty on a medical institution, it shall promptly notify the drug regulatory department at the same level.
Article 61 Pharmaceutical supervisory and administrative departments at all levels, health administrative departments, adverse drug reaction monitoring institutions and their relevant staff members who violate these Measures in the reporting and monitoring of adverse drug reactions and cause serious consequences shall be given administrative sanctions in accordance with relevant provisions.
Article 62 Pharmaceutical producing and trading enterprises and medical institutions that violate relevant regulations and cause damage to drug users shall be liable for compensation according to law.

 

Chapter VIII Supplementary Provisions

 

Article 63 The meanings of the following terms in these Measures:
（1） Adverse drug reactions (ADRs) refer to the harmful reactions of qualified drugs that have nothing to do with the purpose of drug use under normal usage and dosage.
（2） ADR reporting and monitoring refers to the process of finding, reporting, evaluating and controlling ADRs.
（3） Serious adverse drug reaction refers to the reaction that causes one of the following damages due to the use of drugs:
1. Cause death;
2. Life threatening;
3. Carcinogenic, teratogenic and birth defects;
4. Significant or permanent human disability or organ function damage;
5. Causes hospitalization or prolongation of hospitalization time;
6. Other important medical events may occur without treatment.
（4） The term "new adverse drug reactions" refers to the adverse reactions not specified in the drug insert. If the nature, degree, consequence or frequency of the adverse reaction is inconsistent with or more serious than those described in the instructions, it shall be treated as a new adverse drug reaction.
（5） Drug group adverse events refer to the events that cause damage or threat to the health or life safety of a certain number of people during the use of the same drug in a relatively concentrated time and area, and require emergency treatment.
The same drug refers to the drugs with the same name, dosage form and specification produced by the same manufacturer.
（6） Key drug monitoring refers to drug safety monitoring activities carried out to further understand the clinical use of drugs and the occurrence of adverse reactions, and to study the occurrence characteristics, severity and incidence of adverse reactions.
Article 64 An overseas pharmaceutical manufacturer that imports drugs may entrust its office in China or its agency in China to perform the obligation of reporting and monitoring adverse drug reactions in accordance with the provisions of these Measures for drug producing enterprises.
Article 65 If the Ministry of Health and the State Food and Drug Administration have other provisions on the report and monitoring of adverse reactions to vaccines, such provisions shall prevail.
Article 66 Measures for the reporting and monitoring of adverse reactions of preparations made by medical institutions shall be formulated by the drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government in conjunction with the health administrative departments at the same level.
Article 67 These Measures shall come into force as of July 1, 2011. The Administrative Measures for the Reporting and Monitoring of Adverse Drug Reactions (Order No. 7 of the State Food and Drug Administration) promulgated by the State Food and Drug Administration and the Ministry of Health on March 4, 2004 shall be repealed simultaneously.