Regulations on Reporting and Monitoring of Adverse Drug Reactions

"Measures for the Reporting and Monitoring of Adverse Drug Reactions" (Ministry of Health Order No. 81)

 

Published on May 4, 2011

 

Order of the Ministry of Health of the People's Republic of China

 

No. 81

 

 

 

  "Measures for the Reporting and Monitoring of Adverse Drug Reactions" was reviewed and approved by the Ministry of Health executive meeting on December 13, 2010, and is hereby promulgated, effective from July 1, 2011.

 

 

 

  Minister Chen Zhu

 

　　　　　　　　　　　　　　　　　　　　 May 4, 2011

 

 

 

Measures for the Reporting and Monitoring of Adverse Drug Reactions

 

 

Chapter 1 General Provisions

 

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

 

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

 

　　Article 3 The state implements a system for reporting adverse drug reactions. Drug manufacturing enterprises (including overseas manufacturers of imported drugs), drug distribution enterprises, and medical institutions shall report discovered adverse drug reactions in accordance with regulations.

 

　　Article 4 The National Medical Products Administration is responsible for the nationwide reporting and monitoring of adverse drug reactions. Local drug regulatory departments at all levels are responsible for the reporting and monitoring of adverse drug reactions within their administrative regions. Health administrative departments at all levels are responsible for managing medical institutions and implementing the adverse drug reaction reporting system within their administrative regions.

 

　　Local drug regulatory departments at all levels shall establish and improve adverse drug reaction monitoring institutions and be responsible for the technical work of adverse drug reaction reporting and monitoring within their administrative regions.

 

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

 

Chapter 2 Responsibilities

 

　　Article 6 The National Medical Products Administration is responsible for the management of nationwide adverse drug reaction reporting and monitoring and shall perform the following main duties:

 

　　(1) Jointly formulate management regulations and policies for adverse drug reaction reporting and monitoring with the Ministry of Health and supervise their implementation;

 

　　(2) Jointly organize with the Ministry of Health investigations and handling of nationwide significant adverse drug reaction events causing serious consequences and release related information;

 

　　(3) Take emergency control measures and make administrative decisions according to law for drugs confirmed to have serious adverse reactions or group adverse drug events, and announce them to the public;

 

　　(4) Report on the nationwide situation of adverse drug reaction reporting and monitoring;

 

　　(5) Organize inspections of adverse drug reaction reporting and monitoring work in drug manufacturing and distribution enterprises, and jointly with the Ministry of Health organize inspections of medical institutions' adverse drug reaction reporting and monitoring work.

 

　　Article 7 Drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government are responsible for the management of adverse drug reaction reporting and monitoring within their administrative regions and shall perform the following main duties:

 

　　(1) Formulate management regulations for adverse drug reaction reporting and monitoring within their administrative regions jointly with health administrative departments at the same level and supervise their implementation;

 

　　(2) Jointly organize with health administrative departments at the same level investigations and handling of significant adverse drug reaction events occurring within their administrative regions and release related information;

 

　　(3) Take emergency control measures and make administrative decisions according to law for drugs confirmed to have serious adverse reactions or group adverse drug events, and announce them to the public;

 

　　(4) Report on the situation of adverse drug reaction reporting and monitoring within their administrative regions;

 

　　(5) Organize inspections of adverse drug reaction reporting and monitoring work in drug manufacturing and distribution enterprises within their administrative regions, and jointly with health administrative departments at the same level organize inspections of medical institutions' adverse drug reaction reporting and monitoring work within their administrative regions;

 

　　(6) Organize publicity and training on adverse drug reaction reporting and monitoring within their administrative regions.

 

    Article 8 Drug regulatory departments at the municipal and county levels with districts are responsible for the management of adverse drug reaction reporting and monitoring within their administrative regions; jointly organize with health administrative departments at the same level investigations of group adverse drug reaction events occurring within their administrative regions and take necessary control measures; organize publicity and training on adverse drug reaction reporting and monitoring within their administrative regions.

 

　　Article 9 Health administrative departments at or above the county level shall strengthen supervision and management of clinical drug use in medical institutions and take relevant emergency control measures according to law for confirmed serious adverse drug reactions or group adverse drug events within their responsibilities.

 

　　Article 10 The National Center for Adverse Drug Reaction Monitoring is responsible for the technical work of nationwide adverse drug reaction reporting and monitoring and shall perform the following main duties:

　　(1) Collect, evaluate, feedback, and report national adverse drug reaction reporting and monitoring data, and build and maintain the national adverse drug reaction 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 investigations and evaluations of serious adverse drug reactions and assist relevant departments in investigating group adverse drug events;

　　(4) Release warnings about adverse drug reactions;

　　(5) Undertake publicity, training, research, and international exchange related to adverse drug reaction reporting and monitoring.

 

　　Article 11 Provincial adverse drug reaction monitoring institutions are responsible for the technical work of adverse drug reaction reporting and monitoring within their administrative regions and shall perform the following main duties:

　　(1) Collect, evaluate, feedback, and report adverse drug reaction data within their administrative regions, and maintain and manage the adverse drug reaction monitoring information network;

　　(2) Provide technical guidance to municipal and county-level adverse drug reaction monitoring institutions within their administrative regions;

　　(3) Organize investigations and evaluations of serious adverse drug reactions within their administrative regions and assist relevant departments in investigating group adverse drug events;

　　(4) Organize publicity and training on adverse drug reaction reporting and monitoring within their administrative regions.

 

　　Article 12: The district-level city and county-level adverse drug reaction monitoring institutions are responsible for the collection, verification, evaluation, feedback, and reporting of adverse drug reaction reports and monitoring data within their administrative regions; conducting investigations and evaluations of serious adverse drug reactions within their administrative regions; assisting relevant departments in investigating drug-related group adverse events; and undertaking publicity, training, and other work related to adverse drug reaction reporting and monitoring.

 

　　Article 13: Drug manufacturing, operating enterprises, and medical institutions shall establish management systems for adverse drug reaction reporting and monitoring. Drug manufacturing enterprises shall set up specialized institutions and assign full-time personnel; drug operating enterprises and medical institutions shall establish or designate institutions and assign full-time or part-time personnel to undertake adverse drug reaction reporting and monitoring within their units.

 

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

 

Chapter 3: Reporting and Handling

 

　　Section 1: Basic Requirements

 

　　Article 15: Drug manufacturing, operating enterprises, and medical institutions that become aware of or discover adverse reactions possibly related to medication shall report through the National Adverse Drug Reaction Monitoring Information Network; those unable to report online shall submit paper reports to the local adverse drug reaction monitoring institution, which will report online on their behalf.

　　The reported content shall be truthful, complete, and accurate.

 

　　Article 16: Adverse drug reaction monitoring institutions at all levels shall evaluate and manage adverse drug reaction reports and monitoring data within their administrative regions.

 

　　Article 17: Drug manufacturing, operating enterprises, and medical institutions shall cooperate with drug regulatory departments, health administrative departments, and adverse drug reaction monitoring institutions in investigating adverse drug reactions or group adverse events and provide necessary materials for the investigation.

 

Article 18: Drug manufacturing, operating enterprises, and medical institutions shall establish and maintain archives of adverse drug reaction reports and monitoring.

 

Section 2: Individual Adverse Drug Reactions

 

　　Article 19: Drug manufacturing, operating enterprises, and medical institutions shall actively collect adverse drug reactions. Upon learning of or discovering adverse drug reactions, they shall record, analyze, and handle them in detail, fill out the "Adverse Drug Reaction/Event Report Form" (see Appendix 1), and report accordingly.

 

　　Article 20: Domestic drugs within the new drug monitoring period shall report all adverse reactions of the drug; other domestic drugs shall report new and serious adverse reactions.

　　Imported drugs shall report all adverse reactions within 5 years from the date of first approval for import; after 5 years, new and serious adverse reactions shall be reported.

 

　　Article 21: Drug manufacturing, operating enterprises, and medical institutions shall report newly discovered or serious adverse drug reactions within 15 days, with death cases reported immediately; other adverse drug reactions shall be reported within 30 days. Follow-up information shall be reported promptly.

 

　　Article 22: Drug manufacturing enterprises shall investigate known death cases, thoroughly understand the basic information of the death case, drug usage, occurrence and diagnosis and treatment of adverse reactions, and complete the investigation report within 15 days, submitting it to the provincial-level adverse drug reaction monitoring institution where the drug manufacturing enterprise is located.

 

　　Article 23: Individuals who discover new or serious adverse drug reactions may report to the attending physician, drug manufacturing or operating enterprises, or the local adverse drug reaction monitoring institution, and provide relevant medical records if necessary.

 

　　Article 24: District-level city and county-level adverse drug reaction monitoring institutions shall review the authenticity, completeness, and accuracy of received adverse drug reaction reports. The review and evaluation of serious adverse drug reaction reports shall be completed within 3 working days from receipt; other reports shall be reviewed and evaluated within 15 working days.

　　District-level city and county-level adverse drug reaction monitoring institutions shall investigate death cases, thoroughly understand the basic information of the death case, drug usage, occurrence and diagnosis and treatment of adverse reactions, and complete the investigation report within 15 working days from receipt of the report, submitting it to the drug regulatory and health administrative departments at the same level, as well as the higher-level adverse drug reaction monitoring institution.

 

　　Article 25: Provincial-level adverse drug reaction monitoring institutions shall complete the evaluation within 7 working days from the date of receiving the serious adverse drug reaction evaluation opinions submitted by the lower-level adverse drug reaction monitoring institutions.

　　For death cases, the provincial-level adverse drug reaction monitoring institutions at both the event location and the drug manufacturing enterprise location shall promptly analyze and evaluate based on the investigation report, conduct on-site investigations if necessary, and report the evaluation results to the provincial drug regulatory and health administrative departments, as well as the National Adverse Drug Reaction Monitoring Center.

 

　　Article 26: The National Adverse Drug Reaction Monitoring Center shall promptly analyze and evaluate death cases and report the evaluation results to the National Medical Products Administration and the Ministry of Health.

 

　　Section 3: Drug Group Adverse Events

 

　　Article 27: Upon learning of or discovering drug group adverse events, drug manufacturing, operating enterprises, and medical institutions shall immediately report to the local county-level drug regulatory department, health administrative department, and adverse drug reaction monitoring institution by telephone or fax; if necessary, they may report to higher levels. At the same time, they shall fill out the "Basic Information Form for Drug Group Adverse Events" (see Appendix 2), and for each case, promptly fill out the "Adverse Drug Reaction/Event Report Form" and report through the National Adverse Drug Reaction Monitoring Information Network.

 

　　Article 28: Upon learning of drug group adverse events, district-level city and county-level drug regulatory departments shall immediately organize joint on-site investigations with the health administrative departments at the same level and promptly report the investigation results stepwise to the provincial drug regulatory and health administrative departments.

　　Provincial drug regulatory departments and health administrative departments at the same level shall supervise and guide investigations conducted by district-level city and county-level departments, analyze and evaluate drug group adverse events, and for significant drug group adverse events occurring within their administrative regions, organize on-site investigations. The evaluation and investigation results shall be promptly reported to the National Medical Products Administration and the Ministry of Health.

　　For drug group adverse events with significant nationwide impact causing serious consequences, the National Medical Products Administration shall jointly conduct related investigations with the Ministry of Health.

 

　　Article 29: After a pharmaceutical manufacturing enterprise becomes aware of a drug-related mass adverse event, it shall immediately conduct an investigation to thoroughly understand the occurrence of the event, drug usage, patient diagnosis and treatment, as well as drug production, storage, distribution, and any previous similar adverse events. The investigation report shall be completed within 7 days and submitted to the provincial drug regulatory authority and the drug adverse reaction monitoring agency at the location; simultaneously, a self-inspection shall be promptly conducted to analyze the cause of the event. If necessary, production, sales, use, and recall of the related drugs shall be suspended, and the provincial drug regulatory authority shall be notified.

 

　　Article 30: When a drug distribution enterprise discovers a drug-related mass adverse event, it shall immediately inform the drug manufacturing enterprise, promptly conduct a self-inspection, suspend drug sales if necessary, and assist the drug manufacturing enterprise in taking relevant control measures.

 

　　Article 31: Medical institutions discovering a drug-related mass adverse event shall actively treat patients, promptly conduct clinical investigations, analyze the cause of the event, and take emergency measures such as suspending drug use if necessary.

 

　　Article 32: Drug regulatory authorities may take control measures such as suspending production, sales, use, or recalling drugs. Health administrative departments shall take measures to actively organize patient treatment.

 

　　Section 4: Serious Adverse Drug Reactions Occurring Abroad

 

　　Article 33: For serious adverse drug reactions occurring abroad involving imported and domestic drugs (including those collected through spontaneous reporting systems, post-marketing clinical studies, and literature reports), drug manufacturing enterprises shall complete the "Adverse Drug Reaction/Event Report Form for Overseas Occurrences" (see Appendix 3) and submit it to the National Adverse Drug Reaction Monitoring Center within 30 days from the date of awareness. If the National Adverse Drug Reaction Monitoring Center requests original reports and related information, the drug manufacturing enterprise shall submit them within 5 days.

 

　　Article 34: The National Adverse Drug Reaction Monitoring Center shall analyze and evaluate the received adverse drug reaction reports and report to the National Medical Products Administration and the Ministry of Health every six months. Information indicating potential drug safety risks shall be reported promptly.

 

　　Article 35: If imported or domestic drugs are suspended from sale, use, or withdrawn from the market abroad due to adverse drug reactions, the drug manufacturing enterprise shall submit a written report to the National Medical Products Administration and the National Adverse Drug Reaction Monitoring Center within 24 hours of becoming aware.

 

Section 5: Periodic Safety Update Reports

 

　　Article 36: Drug manufacturing enterprises shall regularly summarize and analyze adverse reaction reports and monitoring data for drugs they produce, compile domestic and international safety information, conduct risk-benefit assessments, and prepare periodic safety update reports. The standards for preparing periodic safety update reports shall be formulated by the National Adverse Drug Reaction Monitoring Center.

 

　　Article 37: Domestic drugs with a new drug monitoring period shall submit a periodic safety update report annually from the date of obtaining the approval certificate until the first re-registration, and thereafter every 5 years; other domestic drugs shall report every 5 years.

　　Imported drugs shall submit a periodic safety update report annually from the date of obtaining the import drug approval certificate until the first re-registration, and thereafter every 5 years.

The summary period for periodic safety update reports shall start from the date of obtaining the drug approval certificate, and the submission date shall be within 60 days after the data cutoff date.

 

　　Article 38: Periodic safety update reports for domestic drugs shall be submitted to the provincial adverse drug reaction monitoring agency where the drug manufacturing enterprise is located. Periodic safety update reports for imported drugs (including imported repackaged drugs) shall be submitted to the National Adverse Drug Reaction Monitoring Center.

 

　　Article 39: Provincial adverse drug reaction monitoring agencies shall summarize, analyze, and evaluate the received periodic safety update reports and submit the statistical data and evaluation results of the previous year's reports to the provincial drug regulatory authority and the National Adverse Drug Reaction Monitoring Center before April 1 each year.

 

　　Article 40: The National Adverse Drug Reaction Monitoring Center shall summarize, analyze, and evaluate the received periodic safety update reports and submit the statistical data and evaluation results of the previous year's domestic and imported drugs' reports to the National Medical Products Administration and the Ministry of Health before July 1 each year.

 

Chapter 4: Key Drug Monitoring

 

　　Article 41: Drug manufacturing enterprises shall regularly assess the safety of drugs they produce. For drugs within the new drug monitoring period and those imported within the first 5 years, key monitoring shall be conducted, and monitoring data shall be summarized, analyzed, evaluated, and reported as required; for other drugs produced by the enterprise, key monitoring shall be proactively conducted based on safety conditions.

 

　　Article 42: Drug regulatory authorities at or above the provincial level may require drug manufacturing enterprises to conduct key monitoring on specific drugs based on clinical use and adverse reaction monitoring. If necessary, they may directly organize adverse drug reaction monitoring agencies, medical institutions, and research units to carry out key drug monitoring.

 

　　Article 43: Provincial or higher-level adverse drug reaction monitoring agencies are responsible for supervising and inspecting key monitoring conducted by drug manufacturing enterprises and technically evaluating monitoring reports.

 

　　Article 44: Drug regulatory authorities at or above the provincial level may jointly designate medical institutions as monitoring sites with health administrative departments at the same level to undertake key drug monitoring work.

 

Chapter 5: Evaluation and Control

 

　　Article 45: Drug manufacturing enterprises shall analyze and evaluate collected adverse drug reaction reports and monitoring data and proactively conduct drug safety research.

　　For drugs confirmed to have serious adverse reactions, drug manufacturing enterprises shall promptly inform medical personnel, patients, and the public of adverse drug reactions and rational drug use information through various effective channels; take measures such as modifying labels and instructions, suspending production, sales, use, and recalling to reduce and prevent repeated adverse drug reactions. For drugs with significant adverse reactions, enterprises shall proactively apply for cancellation of their approval certificates.

　　Drug manufacturing enterprises shall report drug safety information and measures taken to the provincial drug regulatory authority at their location and the National Medical Products Administration.

 

　　Article 46: Drug distribution enterprises and medical institutions shall analyze and evaluate collected adverse drug reaction reports and monitoring data and take effective measures to reduce and prevent repeated adverse drug reactions.

 

　　Article 47: Provincial adverse drug reaction monitoring agencies shall conduct comprehensive quarterly analyses of received adverse drug reaction reports, extract safety information requiring attention, evaluate it, propose risk management recommendations, and promptly report to provincial drug regulatory authorities, health administrative departments, and the National Adverse Drug Reaction Monitoring Center.

　　Provincial drug regulatory authorities may take measures such as suspending production, sales, use, and recalling drugs based on analysis and evaluation results, supervise and inspect, and notify health administrative departments at the same level of the measures taken.

 

　　Article 48: The National Adverse Drug Reaction Monitoring Center shall conduct a comprehensive analysis of the serious adverse drug reaction reports received each quarter, extract safety information that requires attention, evaluate it, propose risk management recommendations, and promptly report to the National Medical Products Administration and the Ministry of Health.

 

　　Article 49: Based on the results of drug analysis and evaluation, the National Medical Products Administration may require enterprises to conduct research related to drug safety and efficacy. When necessary, measures such as ordering modifications to drug instructions, suspending production, sales, use, and recalling drugs shall be taken. For drugs with significant adverse reactions, the drug approval certificate shall be revoked, and relevant measures shall be promptly reported to the Ministry of Health.

 

　　Article 50: Drug adverse reaction monitoring agencies at or above the provincial level may require drug manufacturing, operating enterprises, and medical institutions to provide relevant materials according to the needs of analysis and evaluation work. Relevant units shall actively cooperate.

 

Chapter 6: Information Management

 

　　Article 51: Drug adverse reaction monitoring agencies at all levels shall perform statistics and analysis on the received drug adverse reaction reports and monitoring data, and provide feedback in an appropriate form.

 

　　Article 52: The National Adverse Drug Reaction Monitoring Center shall promptly release drug adverse reaction warning information based on the comprehensive analysis and evaluation results of drug adverse reaction reports and monitoring data.

 

　　Article 53: Drug supervision and administration departments at or above the provincial level shall regularly publish reports and monitoring information on drug adverse reactions.

 

　　Article 54: The following information shall be uniformly released by the National Medical Products Administration and the Ministry of Health:

 

　　(1) Drug group adverse events that have a significant impact and cause serious consequences;

 

　　(2) Other important drug adverse reaction information and information deemed necessary for unified release.

　　The information specified in the preceding paragraph for unified release may also be authorized by the National Medical Products Administration and the Ministry of Health to be released by provincial drug supervision and administration departments and health administrative departments.

 

　　Article 55: Trade secrets, personal privacy, patient and reporter information obtained during the process of drug adverse reaction reporting and monitoring shall be kept confidential.

 

　　Article 56: Medical institutions, drug manufacturing enterprises, and drug operating enterprises are encouraged to share drug adverse reaction information.

 

　　Article 57: The content of drug adverse reaction reports and statistical data are the basis for strengthening drug supervision and guiding rational drug use.

 

Chapter 7: Legal Liability

 

　　Article 58: If a drug manufacturing enterprise has any of the following circumstances, the local drug supervision and administration department shall issue a warning, order correction within a time limit, and may impose a fine of not less than 5,000 yuan and not more than 30,000 yuan:

 

　　(1) Failure to establish a drug adverse reaction reporting and monitoring management system as required, or lack of a dedicated institution or full-time personnel responsible for the unit's drug adverse reaction reporting and monitoring work;

　　(2) Failure to establish and maintain drug adverse reaction monitoring archives;

　　(3) Failure to carry out drug adverse reaction or group adverse event reporting, investigation, evaluation, and handling as required;

　　(4) Failure to submit periodic safety update reports as required;

　　(5) Failure to conduct key monitoring as required;

　　(6) Failure to cooperate with investigations related to serious drug adverse reactions or group adverse events;

　　(7) Other violations of the provisions of these Measures.

　　If a drug manufacturing enterprise has any of the circumstances specified in items (4) or (5) of the preceding paragraph, the corresponding drug shall not be re-registered in accordance with the provisions of the "Drug Registration Management Measures."

 

　　Article 59: If a drug operating enterprise has any of the following circumstances, the local drug supervision and administration department shall issue a warning and order correction within a time limit; if not corrected within the time limit, a fine of up to 30,000 yuan shall be imposed:

　　(1) No full-time or part-time personnel responsible for the unit's drug adverse reaction monitoring work;

　　(2) Failure to carry out drug adverse reaction or group adverse event reporting, investigation, evaluation, and handling as required;

　　(3) Failure to cooperate with investigations related to serious drug adverse reactions or group adverse events.

 

　　Article 60: If a medical institution has any of the following circumstances, the local health administrative department shall issue a warning and order correction within a time limit; if not corrected within the time limit, a fine of up to 30,000 yuan shall be imposed. If the circumstances are serious and cause severe consequences, the local health administrative department shall impose administrative sanctions on the responsible persons:

 

　　(1) No full-time or part-time personnel responsible for the unit's drug adverse reaction monitoring work;

　　(2) Failure to carry out drug adverse reaction or group adverse event reporting, investigation, evaluation, and handling as required;

　　(3) Failure to cooperate with investigations related to serious drug adverse reactions and group adverse events.

 

　　If the drug supervision and administration department discovers any of the behaviors specified in the preceding paragraph by a medical institution, it shall transfer the case to the health administrative department at the same level for handling.

　　When the health administrative department makes an administrative penalty decision on a medical institution, it shall promptly notify the drug supervision and administration department at the same level.

 

　　Article 61: Drug supervision and administration departments, health administrative departments, drug adverse reaction monitoring agencies at all levels, and their relevant personnel who violate these Measures in drug adverse reaction reporting and monitoring management work and cause serious consequences shall be subject to administrative sanctions in accordance with relevant regulations.

 

　　Article 62: Drug manufacturing, operating enterprises, and medical institutions that violate relevant regulations and cause damage to drug users shall bear compensation liability according to law.

 

Chapter 8: Supplementary Provisions

 

　　Article 63: The meanings of the following terms in these Measures are:

　　(1) Adverse drug reaction refers to harmful reactions unrelated to the intended use of qualified drugs under normal usage and dosage.

　　(2) Drug adverse reaction reporting and monitoring refers to the process of discovering, reporting, evaluating, and controlling adverse drug reactions.

　　(3) Serious adverse drug reaction refers to reactions causing any of the following damages due to drug use:

　　1. Resulting in death;

　　2. Life-threatening;

　　3. Carcinogenic, teratogenic, or causing birth defects;

　　4. Causing significant or permanent bodily disability or organ function damage;

　　5. Causing hospitalization or prolonged hospitalization;

　　6. Causing other important medical events, such as those that may lead to the above conditions if untreated.

　　(4) New adverse drug reactions refer to adverse reactions not listed in the drug instructions. If the instructions already describe the reaction, but the nature, severity, consequences, or frequency of the adverse reaction differ from or are more severe than those described, it shall be treated as a new adverse drug reaction.

　　(5) Drug group adverse events refer to incidents where the same drug, during use, causes harm or threatens the health or life safety of a certain number of people within a relatively concentrated time and area, requiring urgent handling.

　　The same drug: refers to 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, studying characteristics such as the nature, severity, and incidence of adverse reactions.

 

　　Article 64: Overseas pharmaceutical manufacturers of imported drugs may entrust their offices or agents within China to fulfill the obligations of adverse drug reaction reporting and monitoring in accordance with the provisions for drug manufacturers under these measures.

 

　　Article 65: If the Ministry of Health and the National Medical Products Administration have separate provisions for vaccine adverse reaction reporting and monitoring, those provisions shall prevail.

 

　　Article 66: The management measures for adverse reaction reporting and monitoring of medical institution preparations shall be formulated by the drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government in conjunction with the corresponding health administrative departments.

 

　　Article 67: These measures shall come into effect on July 1, 2011. The "Measures for the Reporting and Monitoring of Adverse Drug Reactions" promulgated by the National Medical Products Administration and the Ministry of Health on March 4, 2004 (Order No. 7 of the National Medical Products Administration) shall be repealed simultaneously.