药品不良反应报告和监测管理办法-英文版
Provisions for Adver Drug Reaction Reporting and Monitoring (Order No.81
of the Ministry of Health)
Announced on 4 May 2011
Order of the Ministry of Health of the People’s Republic of China
salary是什么意思No.81
The Provisions for Adver Drug Reaction Reporting and Monitoring approved in the hettich>bleach什么意思
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, Minister
4 May 2011
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Provisions for Adver Drug Reaction Reporting and Monitoring
Chapter I General Provisions
Article 1 The Provisions are formulated according to the Drug Administration
Law of the People’s Republic of China and other relevant laws and regulations for the
tandardize adver purpo of strengthening supervision over drugs in the market, slady antebellum
advancement
drug reaction reporting and monitoring, and controlling drug risk timely and effectively to ensure the safety of public drug u.
Article 2 The Provisions are applicable to activities related to reporting, monitoring and supervision of adver drug reaction within the territory of the People’s Republic of China.
Comments: excluding Hong Kong, Taiwan, and Macao
Article 3 The State adopts the adver drug reaction reporting system. Drug manufacturers (including overas manufacturers of imported drugs), drug distributors and medical institutions shall report adver 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 adver drug reaction reporting and monitoring across the nation. Local drug regulatory departments shall be in charge of implementation of adver drug reaction reporting and monitoring within their respective jurisdiction. Health administrative departments at various levels shall be responsible for the implementation of the adver drug reaction reporting system by medical institutions within their respective jurisdiction.
Local health administrative departments at various levels shall establish and maintain an adver drug reaction monitoring body to be in charge of the technical aspect of adver drug reaction reporting and monitoring within their respective jurisdiction. Article 5 The State encourages all citizens, legal persons and other organizations to report adver drug reaction. 玉米的营养价值
Chapter II Responsibilities
Article 6 The State Food and Drug Administration shall be in charge of implementation of adver 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 adver drug reaction reporting and monitoring, and to supervi implementation thereof;
(B) To, by working with the Ministry of Health, investigate and handle group adver drug reaction events which have caud vere conquences and have great impact nationwidely, and to relea relevant information;
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(C) To take emergency control measures over drugs which have caud identified rious adver drug reaction or cluster adver drug events, make administrative punishment decisions, and make announcement to the public;
theanswer(D) To issue bulletin on adver drug reaction reporting and monitoring nationly; (E) To inspect adver drug reaction reporting and monitoring activities carried out by drug manufacturers and drug distributors, and to, by working with the Ministry of Health, inpct adver 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 adver 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 adver drug reaction reporting and monitoring within their respective jurisdiction, and to supervi implementation thereof; (B) To, by working with the health administrative department at the same level, investigate and handle cluster adver drug events which have caud vere conquences and have great impact within their respective jurisdiction, and to relea relevant information;
(C) To take emergency control measures over drugs which have caud identified vere adver drug reaction or cluster adver drug events, make administrative punishment decisions, and make announcement to the public;
(D) To issue bulletin on adver drug reaction reporting and monitoring within their respective jurisdiction;
