【正文】 Provisions for Adverse Drug Reaction Reporting and Monitoring (Order of the Ministry of Health)Announced on 4 May 2011Order of the Ministry of Health of the People’s Republic of ChinaThe Provisions for Adverse Drug Reaction Reporting and Monitoring approved in the conference on ministerial affairs held by the Ministry of Health on 13 December 2010 is hereby announced for implementation as of 1 July 2011.Chen Zhu, Minister4 May 2011Provisions for Adverse Drug Reaction Reporting and MonitoringChapter I General ProvisionsArticle 1 These Provisions are formulated according to the Drug Administration Law of the People’s Republic of China and other relevant laws and regulations for the purpose of strengthening supervision over drugs in the market, standardize adverse drug reaction reporting and monitoring, and controlling drug risk timely and effectively to ensure the safety of public drug use.Article 2 These Provisions are applicable to activities related to reporting, monitoring and supervision of adverse drug reaction within the territory of the People’s Republic of China.Comments: excluding Hong Kong, Taiwan, and MacaoArticle 3 The State adopts the adverse drug reaction reporting system. Drug manufacturers (including overseas manufacturers of imported drugs), drug distributors and medical institutions shall report adverse drug reaction identified by them in accordance with relevant provisions.Article 4 The State Food and Drug Administration shall be in charge of implementation of adverse drug reaction reporting and monitoring across the nation. Local drug regulatory departments shall be in charge of implementation of adverse drug reaction reporting and monitoring within their respective jurisdiction. Health administrative departments at various levels shall be responsible for the implementation of the adverse drug reaction reporting system by medical institutions within their respective jurisdiction.Local health administrative departments at various levels shall establish and maintain an adverse drug reaction monitoring body to be in charge of the technical aspect of adverse drug reaction reporting and monitoring within their respective jurisdiction. Article 5 The State encourages all citizens, legal persons and other organizations to report adverse drug reaction.Chapter II ResponsibilitiesArticle 6 The State Food and Drug Administration shall be in charge of implementation of adverse drug reaction reporting and monitoring across the nation and shall perform the following duties:(A) To, by working with the Ministry of Health, prepare regulations and policies for adverse drug reaction reporting and monitoring, and to supervise implementation thereof。(B) To, by working with the Ministry of Health, investigate and handle group adverse drug reaction events which have caused severe consequences and have great impact nationwidely, and to release relevant information。(C) To take emergency control measures over drugs which have caused identified serious adverse drug reaction or cluster adverse drug events, make administrative punishment decisions, and make announcement to the public。(D) To issue bulletin on adverse drug reaction reporting and monitoring nationly。 (E) To inspect adverse drug reaction reporting and monitoring activities carried out by drug manufacturers and drug distributors, and to, by working with the Ministry of Health, inpsect adverse drug reaction reporting and monitoring activities carried out by medical institutions.Article 7 Drug regulatory departments of provinces, autonomous regions and municipalities shall be in charge of implementation of adverse drug reaction reporting and monitoring within their respective jurisdiction and shall perform the following duties:(A) To, by working with the health administrative department at the same level, prepare regulations and policies for adverse drug reaction reporting and monitoring within their respective jurisdiction, and to supervise implementation thereof。(B) To, by working with the health administrative department at the same level, investigate and handle cluster adverse drug events which have caused severe consequences and have great impact within their respective jurisdiction, and to release relevant information。(C) To take emergency control measures over drugs which have caused identified severe adverse drug reaction or cluster adverse drug events, make administrative punishment decisions, and make announcement to the public。(D) To issue bulletin on adverse drug reaction reporting and monitoring within their respective jurisdiction。 (E) To inspect adverse drug reaction reporting and monitoring activities carried out by drug manufacturers and drug distributors within their respective jurisdiction, and to, by working with the health administrative department at the same level,inspect adverse drug reaction reporting and monitoring activities carried out by medical institutions within their respective jurisdiction。 and(F) To organize propaganda and training on adverse drug reaction reporting and monitoring within their respective jurisdiction.Article 8 Drug regulatory departments at municipal / county level under their petent provincial department shall be in charge of implementation of adverse drug reaction reporting and monitoring within their respective jurisdiction. They shall, by working with the health administrative department the same level, investigate cluster adverse drug events within their respective jurisdiction and take necessary control measures, and shall carry out propaganda and training on adverse drug reaction reporting and monitoring within their respective jurisdiction.Article 9 Health administrative departments above county level shall strengthen regulatory management of clinical use of drugs by medical institutions, and shall take emergency control measures against identified serious adverse drug reaction or cluster adverse