Chapter III Reporting and Handling

Section I Basic Requirements

Article 15 Drug manufacturers, distributors and medical institutions shall report through the national ADR monitoring information network any drug-related adverse reactions that they become aware of or discover; if online reporting conditions are unavailable, they shall send paper reports to local ADR monitoring institutions and the local ADR monitoring institutions shall submit online reports on their behalf.

The reports shall be authentic, complete and accurate.

Article 16 The ADR monitoring institutions at all levels shall evaluate and manage the ADR reporting and monitoring data within their respective administrative regions.

Article 17 Drug manufacturers, distributors and medical institutions shall cooperate with drug regulatory departments, health administrative departments and ADR monitoring institutions in investigating ADRs or ADE clusters and provide materials necessary for the investigation.

Article 18 Drug manufacturers, distributors and medical institutions shall establish and maintain archives for ADR reporting and monitoring.

Section 2 Individual ADR Cases

Article 19 Drug manufacturers, distributors and medical institutions shall spontaneously collect ADRs. When an ADR is known or discovered, it shall be recorded, analyzed and handled in detail, and a Form for ADR/ADE Report (see Attached Table 1) shall be filled out and submitted.

Article 20 All ADRs shall be reported for domestic drug products within the New Drug Observation Period; new and serious ADRs shall be reported for other domestic drug products.

All ADRs shall be reported for imported drugs within 5 years from the date of first approval for import; new and serious ADRs shall be reported for drugs that have been imported for more than 5 years.

Article 21 Drug manufacturers, distributors and medical institutions shall report any new and serious ADRs no later than 15 days from discovering or becoming aware of the information, death case shall be reported immediately, and other ADRs shall be reported no later than 30 days. Follow-up information (if any) shall be reported in a timely manner.

Article 22 Drug manufacturers shall investigate known death cases to have a detailed understanding of the basic information about the case, information of drug use, and occurrence, diagnosis and treatment of the adverse reaction, etc. The investigation report shall be completed within 15 days and submitted to the provincial ADR monitoring institution where the drug manufacturer is located.

Article 23 Individuals, when discovering new or serious ADRs may report to their physicians or drug manufacturers, distributors or local ADR monitoring institutions; if necessary, relevant medical records shall be provided.

Article 24 ADR monitoring institutions of municipalities with districts and counties shall review the authenticity, completeness and accuracy of ADR reports received. The review and evaluation of serious ADR reports shall be completed within 3 working days after receiving the reports; the review and evaluation of other reports shall be completed within 15 working days.

ADR monitoring institutions of municipalities with districts and counties shall investigate death cases to have a detailed understanding of the basic information about the case, information of drug use, and occurrence, diagnosis and treatment of the adverse reactions, etc. The investigation report shall be completed within 15 days after receiving the case report and submitted to the drug regulatory department and health administrative department at the same level and the ADR monitoring institution at a higher level.

Article 25 Provincial ADR monitoring institutions shall complete the evaluation within 7 working days after receiving the serious ADR evaluation statements submitted by the ADR monitoring institution at a lower level.

For death cases, the provincial ADR monitoring institutions where the event occurs and where the drug manufacturer is located shall analyze and evaluate the event based on the investigation report in a timely manner, conduct on-site investigation when necessary, and report the evaluation results to the provincial drug regulatory departments and health administrative departments and the National Center for ADR Monitoring.

Article 26 The National Center for ADR Monitoring shall analyze and evaluate the death cases and report the evaluation results to the SFDA and the Ministry of Health in a timely manner.

Section 3 Adverse Drug Event Clusters

Article 27 Drug manufacturers, distributors and medical institutions shall, upon knowing or discovering ADE clusters, immediately report to the county-level drug regulatory departments, health administrative departments and ADR monitoring institutions where they are located by telephone or by fax; when necessary, they may report directly to authorities at a higher level; at the same time, a Form for Basic Information of ADE Clusters (see Attached Table 2) and a Form for ADR/ADE Report for each case shall be filled out promptly and submitted via the national ADR monitoring information network.

Article 28 Drug regulatory departments of municipalities with districts and counties shall, upon knowing of ADE clusters, immediately conduct on-site investigation jointly with the health administrative departments at the same level, and promptly report the investigation results level by level to the provincial drug regulatory departments and health administrative departments.

Provincial drug regulatory departments, jointly with the health administrative departments at the same level, shall supervise and guide the investigation conducted by drug regulatory departments of municipalities with districts and counties, analyze and evaluate ADE clusters, and organize on-site investigation on ADE clusters that occur within their administrative regions and have a major impact. The evaluation and investigation results shall be reported to the SFDA and the Ministry of Health in a timely manner.

SFDA shall, jointly with the Ministry of Health, conduct investigation on ADE clusters that have a major impact nationwide and result in serious consequences.

Article 29 Upon knowing of any ADE cluster, a drug manufacturer shall immediately carry out investigation to have a detailed understanding of the occurrence of ADE cluster, information of drug use, diagnosis and treatment of patients involved, and production, storage, distribution and previous similar adverse events of the drug, etc., complete the investigation report within 7 days, and submit it to the provincial drug regulatory department and the ADR monitoring institution where the manufacturer is located. At the same time, the drug manufacturer shall rapidly conduct self-inspection, analyze the cause of the events, suspend production, sales and use, recall relevant drugs when necessary, and report to the provincial drug regulatory department where it is located.

Article 30 Upon discovering any ADE cluster, a drug distributor shall immediately inform the drug manufacturer and rapidly conduct self-inspection at the same time, temporarily suspend drug sales when necessary, and assist the drug manufacturer in taking relevant control measures.

Article 31 Upon discovering any ADE cluster, a medical institution shall actively treat patients, conduct clinical investigation rapidly, analyze cause of the event, and take emergency measures such as suspending drug use when necessary.

Article 32 Drug regulatory departments may take such control measures as suspension of production, sales and use or recall of drugs. Health administrative departments shall take active measures to organize treatment of patients.

Section 4 Serious ADRs Occurred Overseas

Article 33 Where serious ADRs (including those collected from spontaneous reporting systems, discovered during post-marketing clinical study, and published in literatures) of imported drugs and domestic drugs occur overseas, a Form for Overseas ADR/ADE Report (see Attached Table 3) shall be filled out by the drug manufacturer and submitted to the National Center for ADR Monitoring within 30 days after knowledge of the event. If the original report and relevant information are requested by the National Center for ADR Monitoring, they shall be submitted within 5 days by the drug manufacturer.

Article 34 The National Center for ADR Monitoring shall analyze and evaluate ADR reports received and report to the SFDA and the Ministry of Health semiannually; once information indicating potential drug safety risks is identified, reports shall be submitted in a timely manner.

Article 35 Where imported drugs and domestic drugs are suspended from sale and use or withdrawn from market due to ADRs occurred overseas, the drug manufacturer shall submit a written report to the SFDA and the National Center for ADR monitoring within 24 hours after knowing the event.

Section 5 Periodic Safety Update Report (PSUR)

Article 36 Drug manufacturers shall regularly summarize and analyze the ADR reporting and monitoring data of drugs they manufactured, collect domestic and overseas safety information, conduct risk-benefit assessment, and prepare PSURs. The specifications for preparing PSURs shall be developed by the National Center for ADR monitoring.

Article 37 For domestic drugs with a New Drug Observation Period, PSURs shall be submitted every year from the date when approval documents are obtained to the date of first re-registration; thereafter, the reports shall be submitted every 5 years. For other domestic products, PSURs shall be submitted every 5 years.

For drugs imported for the first time, PSURs shall be submitted every year from the date when approval documents for imported drugs are obtained to the date of first re-registration; thereafter, the PSURs shall be submitted every 5 years.

The time interval covered in PSURs shall be counted starting from the date when drug approval documents are obtained. The submission date shall bewithin 60 days after the date of data lock point.

Article 38 PSURs for domestic drugs shall be submitted to the provincial ADR monitoring institutions where the drug manufacturers are located. PSURs for imported drugs (including sub-packaged imported drugs) shall be submitted to the National Center for ADR Monitoring.

Article 39 Provincial ADR monitoring institutions shall summarize, analyze and evaluate PSURs received and report the statistics and the analysis and evaluation results of previous year's PSURs to the provincial drug regulatory departments and the National Center for ADR Monitoring before April 1 each year.

Article 40 The National Center for ADR Monitoring shall summarize, analyze and evaluate PSURs received and report the statistics and the analysis and evaluation results of previous year's PSURs for domestic and imported drugs to the SFDA and the Ministry of Health before July 1 each year.