Chapter VI Information Management

Article 51 ADR monitoring institutions at all levels shall conduct statistical analysis on the ADR reporting and monitoring data received and provide feedback in appropriate forms.

Article 52 The National Center for ADR Monitoring shall release ADR warning information in a timely manner based on results of comprehensive analysis and evaluation on ADR reporting and monitoring data.

Article 53 Drug regulatory departments at or above the provincial level shall regularly release information on ADR reporting and monitoring.

Article 54 The following information shall be released in a unified manner by the SFDA and the Ministry of Health:

(I)  ADE clusters that have a major impact and result in serious consequences;

(II) Other important ADR information and information necessary for uniform release.

Information defined in the preceding paragraph that needs unified release may also be released by provincial drug regulatory departments and health administrative departments under the authorization of the SFDA and the Ministry of Health.

Article 55 Commercial secrets, personal privacy, and patient and reporter information obtained during the process of ADR reporting and monitoring shall be kept confidential.

Article 56 Medical institutions, drug manufacturers and distributors shall be encouraged to share ADR information.

Article 57 The contents and statistical data of ADR reports are the basis for strengthening drug regulation and providing guidance for rational drug use.

Chapter VII Legal Liabilities

Article 58 Under any of the following circumstances, a drug manufacturer shall be given a warning and ordered to make corrections within a specified time limit, and may be imposed a penalty of not less than RMB 5,000 yuan but not more than RMB 30,000 yuan by the local drug regulatory department where the enterprise is located:

(I) Having not established an ADR reporting and monitoring management system as required, or having no specialized department or full-time personnel in charge of ADR reporting and monitoring within the enterprise;

(II) Having not established and maintained achieves for ADR monitoring;

(III) Having not conducted the reporting, investigation, evaluation, and handling of ADRs or ADE clusters as required;

(IV) Having not submitted PSURs as required;

(V)  Having not conducted intensive surveillance as required;

(VI) Not cooperating with the investigation of serious ADRs or ADE clusters;

(VII)  Other violations against these Provisions.

Where a drug manufacturer violates Item (IV) or (V) of the preceding paragraph, re-registration of relevant drugs shall be prohibited in accordance with requirements of the Provisions for Drug Registration.

Article 59 Under any of the following circumstances, a drug distributor shall be given a warning and ordered to make corrections within a specified time limit by the local drug regulatory department where the enterprise is located; where corrections are not made within the time limit, a penalty of not more than RMB 30,000 yuan shall be imposed:

(I)  Having no full-time or part-time personnel in charge of ADR monitoring within the enterprise;

(II)  Having not conducted the reporting, investigation, evaluation, and handling of ADRs or ADE clusters as required;

(III) Not cooperating with the investigation of serious ADRs or ADE clusters.

Article 60 Under any of the following circumstances, a medical institution shall be given a warning and ordered to make corrections within a specified time limit by the local health administrative department where the medical institution is located; where corrections are not made within the time limit, a penalty of not more than RMB 30,000 yuan shall be imposed. In serious circumstances that cause serious consequences, administrative sanctions shall be given by the local health administrative department to the relevant responsible person:

(I) Having no full-time or part-time personnel in charge of ADR monitoring within the institution;

(II) Having not conducted the reporting, investigation, evaluation, and handling of ADRs or ADE clusters as required;

(III) Not cooperating with the investigation of serious ADRs and ADE clusters.

Where any violation by a medical institution defined in the preceding paragraph is identified by the drug regulatory department, the case shall be transferred to the health administrative department at the same level for handling.

Where the health administrative department decides to give administrative penalty to a medical institution, the drug regulatory department at the same level shall be informed promptly.

Article 61 Where drug regulatory departments, health administrative departments and ADR monitoring institutions at all levels and their staff violate these Provisions in the management of ADR reporting and monitoring and cause serious consequences, administrative sanctions shall be given in accordance with relevant provisions.

Article 62 Drug manufacturers, distributors and medical institutions shall be liable for compensation in accordance with law if they violate relevant regulations and cause harm to drug users.

Chapter VIII Supplementary Provisions

Article 63 Terms used in these Provisions are defined as follows:

(I)  An adverse drug reaction refers to an unintended noxious response to a drug of acceptable quality used at normal usage.

(II) ADR reporting and monitoring refers to the process of detecting, reporting, evaluating and controlling ADRs.

(III) A serious ADR is a response leading to any of the following damages caused by drug use:

1. Resulting in death;

2. Life threatening;

3. Causing cancer, malformation or congenital anomaly;

4. Resulting in significant or permanent disability or organ damage;

5. Requiring inpatient hospitalization or resulting in prolongation of existing hospitalization;

6. Other medically important events that without treatment could lead to the aforementioned outcomes.

(IV) A new ADR refers to any adverse reaction that is not listed on the package insert. An ADR that is listed but is in consistent with or more severe than that described on the package insert in nature, severity, outcome and frequency shall be handled as a new ADR.

(V)  An ADE cluster refers to an event which causes damage or threat to the health or life of a certain number of people in a relatively concentrated time span and region during the use of the same drug and needs to be handled urgently.

The same drug refers to drugs of the same name, dosage form and strength manufactured by the same drug manufacturer.

(VI) Drug intensive surveillance refers to drug safety monitoring activities conducted in order to further understand the clinical use of drugs and occurrence of adverse reactions and study the characteristics, severity, and incidence rate, etc. of adverse reactions.

Article 64 An overseas drug manufacturer of imported drugs may authorize its representative office or its agency within the territory of China to fulfill the obligations for ADR reporting and monitoring in accordance with the requirements of these Provisions for drug manufacturers.

Article 65 Where other provisions are formulated by the Ministry of Health and the SFDA on the reporting and monitoring of vaccine adverse reactions, such provisions shall prevail.

Article 66 Provisions on adverse reaction reporting and monitoring for pharmaceutical preparations of medical institutions shall be developed by the drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government together with the health administrative departments at the same level.

Article 67 These Provisions shall go into force as of July 1, 2011. The Provisions for Adverse Drug Reaction Reporting and Monitoring (SFDA Order No.7) promulgated by the SFDA and the Ministry of Health on March 4, 2004 shall be repealed simultaneously.

Note: In case of any difference in interpretation between the English version and the Chinese version, the Chinese version shall prevail.