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

No. 81

The Provisions for Adverse Drug Reaction Reporting and Monitoring, adopted at the executive meeting of the Ministry of Health on December 13, 2010, is hereby promulgated and shall go into effect as of July 1, 2011.

Minister: Chen Zhu

May 4, 2011

Provisions for Adverse Drug Reaction Reporting and Monitoring

Chapter I General Provisions

Article 1 These Provisions are formulated in accordance with the Drug Administration Law of the People's Republic of China and other relevant laws and regulations in order to reinforce the post-marketing supervision and administration of drugs, standardize adverse drug reaction (ADR) reporting and monitoring, control drug risks promptly and effectively, and ensure safety of drug use for the public.

Article 2 These Provisions are applicable to ADR reporting, monitoring, supervision and administration carried out within the territory of the People's Republic of China.

Article 3 The State implements anADR reporting system. Drug manufacturers (including overseas pharmaceutical manufacturers of imported drugs), drug distributors and medical institutions shall report ADRsas regulated.

Article 4 The State Food and Drug Administration (SFDA) is in charge of ADR reporting and monitoring nationwide; local drug regulatory departments at all levels are in charge of ADR reporting and monitoring within their respective administrative regions. The health administrative departments at all levels are responsible for the management relevant to the implementation of ADR reporting system in medical institutions within their respective administrative regions.

The local drug regulatory departments at all levels shall establish and improve ADR monitoring institutions to be responsible for the technical work of ADR reporting and monitoring within their respective administrative regions.

Article 5 The State encourages citizens, legal persons and other organizations to report ADRs.

Chapter II Responsibilities

Article 6 SFDA is responsible for the management of ADR reporting and monitoring nationwide, and fulfills the following main responsibilities:

(I)  In conjunction with the Ministry of Health, formulate provisions and policies on ADR reporting and monitoring and supervise the implementation thereof;

(II) Jointly with the Ministry of Health, organize and carry out investigation and handling of adverse drug event (ADE) clusters that have a national impact and result in serious consequences, and release relevant information;

(III) Take emergency control measures for drugs that have been verified for causing serious ADRs or ADE clusters, make administrative handling decisions, and announce the decisions to the public;

(IV) Circulate information of ADR reporting and monitoring nationwide;

(V)  Organize inspection of ADR reporting and monitoring carried out by drug manufacturers and distributors; organize inspection of ADR reporting and monitoring carried out by medical institutions jointly with the Ministry of Health.

Article 7 Drug regulatory departments of the provinces, autonomous regions and municipalities directly under the Central Government are responsible for management of ADR reporting and monitoring within their respective administrative regions, and fulfill the following main responsibilities:

(I)  In conjunction with the health administrative departments at the same level, formulate management regulations on ADR reporting and monitoring within their administrative regions in accordance with these Provisions, and supervise the implementation thereof;

(II) Jointly with the health administrative departments at the same level, organize and carry out investigation and handling of ADE clusters that have a major impact within their administrative regions, and release relevant information;

(III) Take emergency control measures for drugs that have been verified for causing serious ADRs or ADE clusters, make administrative handling decisions, and announce the decisions to the public;

(IV) Circulate information of ADR reporting and monitoring within their administrative regions;

(V)  Organize inspection of ADR reporting and monitoring carried out by drug manufacturers and distributors within their administrative regions; jointly with the health administrative departments at the same level, organize inspection of ADR reporting and monitoring carried out by medical institutions within their administrative regions.

(VI)  Organize and carry out publicity and training on ADR reporting and monitoring within their administrative regions.

Article 8 Drug regulatory departments of municipalities with districts and of counties are responsible for management of ADR reporting and monitoring within their respective administrative regions; organize and carry out investigation on ADE clusters occurred within their administrative regions and take necessary control measures in conjunction with the health administrative departments at the same level; and organize and carry out publicity and training on ADR 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 emergency control measures on verified serious ADRs or ADE clusters as per their duties in accordance with laws and regulations.

Article 10 The National Center for ADR Monitoring is responsible for the technical work of ADR reporting and monitoring nationwide, and fulfills the following main responsibilities:

(I) Undertake the collection, evaluation, feedback and reporting of ADR reporting and monitoring data nationwide, and set up and maintain the national information network for ADR monitoring;

(II) Formulate the technical standards and norms for ADR reporting and monitoring and provide technical guidance to local ADR monitoring institutions at all levels;

(III) Organize and carry out investigation and evaluation on serious ADRs and assist relevant departments in investigating ADE clusters;

(IV) Release ADR warning information;

(V)  Undertake the publicity, training, study and international exchange on ADR reporting and monitoring.

Article 11 Provincial ADR monitoring institutions are responsible for the technical work of ADR reporting and monitoring within their respective administrative regions and exercise the following main responsibilities:

(I) Undertake the collection, evaluation, feedback and reporting of ADR reporting and monitoring data, and maintain and manage the information network for ADR monitoring within their respective administrative regions;

(II) Provide technical guidance to the ADR monitoring institutions of municipalities with districts and counties;

(III) Organize and carry out investigation and evaluation on serious ADRs within their respective administrative regions and assist relevant departments in investigating ADE clusters;

(IV) Organize and carry out publicity and training on ADR reporting and monitoring within their respective administrative regions.

Article 12 The ADR monitoring institutions of municipalities with districts and of counties are responsible for the collection, verification, evaluation, feedback, and reporting of ADR reporting and monitoring data within their respective administrative regions; conduct investigation and evaluation on serious ADRs within their respective administrative regions; assist relevant departments in investigating ADE clusters; and carry out publicity and training on ADR reporting and monitoring.

Article 13 Drug manufacturers, distributors and medical institutions shall establish ADR reporting and monitoring management systems. To undertake the task of ADR reporting and monitoring within the enterprises or institutions, drug manufacturers shall establish specialized departments and allocate full-time personnel while drug distributors and medical institutions shall establish or designate departments and allocate full-time or part-time personnel.

Article 14 Staff engaged in ADR reporting and monitoring shall have relevant professional knowledge on medicine, pharmacology, epidemiology or statistics, etc. and are capable of scientifically analyzing and evaluating ADRs.