2021年1月23日发(作者：想象力英文)
药品不良反应报告和监测管理办法
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英文版

Provisions for Adverse 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

No.81
The 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, Minister
4 May 2011
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Provisions for Adverse Drug Reaction Reporting and Monitoring
Chapter I General Provisions
Article 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
tandardize adverse purpose of strengthening supervision over drugs
in the market, s
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 Macao
Article 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 Responsibilities
Article 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;
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(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 competent 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 drug events
within their scope of power according to law.
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Article 10 The National Adverse Drug Reaction Monitoring Center
shall be in charge of the technical aspect of adverse drug reaction
reporting and monitoring and shall perform the following duties:
(A) To collect, evaluate, feedback and report adverse drug reaction
reporting and monitoring data across the nation, and to construct and
maintain the National Adverse Drug Reaction Monitoring Information
Network;
(B) To prepare the technical standards and norms for adverse drug
reaction reporting and monitoring, and to provide technical guidance to
local adverse drug reaction monitoring bodies;
(C) To organize the investigation and evaluation of serious adverse
drug reactions, and to assist relevant departments to carry out
investigation on cluster adverse drug events;
(D) To release adverse drug reaction alerts; and
(E) To organize propaganda, training, research and international
exchange regarding adverse drug reaction reporting and monitoring.
Article 11 Adverse drug reaction monitoring bodies at provincial
level shall be in charge of the technical aspect of adverse drug
reaction reporting and monitoring within their respective jurisdiction
and shall perform the following duties: (A) To collect, evaluate,
feedback and report adverse drug reaction reporting and monitoring data
within their respective jurisdiction, and to maintain and manage the
adverse drug reaction monitoring information network;
(B) To provide technical guidance to adverse drug reaction
monitoring bodies at municipal / county level (which municipality or
county is divided by districts); (C) To organize the investigation and
evaluation of serious adverse drug reactions within their respective
jurisdiction, and to assist relevant departments to carry out
investigation on cluster adverse drug events;
(D) To organize propaganda and training on adverse drug reaction
reporting and monitoring within their respective jurisdiction.
Article 12 adverse drug reaction monitoring bodies at municipal /
county level under their competent provincial department shall collect,
verify, evaluate, feedback and report adverse drug reaction reporting
and monitoring data within their respective jurisdiction, organize the
investigation and evaluation of serious adverse drug reactions within
their respective jurisdiction, assist relevant departments to carry out
investigation on group adverse drug reaction events, and organize
propaganda and training on adverse drug reaction reporting and
monitoring.
Article 13 Drug manufacturers, drug distributors and medical
institutions shall establish an adverse drug reaction reporting and
monitoring system. Drug manufacturers shall set up an independent unit
and designate full-time staff to be in charge of the adverse drug
reaction reporting and monitoring. Drug distributors and medical
institutions shall set up or designate full- time or part-time staff(s)
from an independent unit to be in charge of the adverse drug reaction
reporting and monitoring t.
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Article 14 Personnel engaged in adverse drug reaction reporting and
monitoring shall have medical, pharmaceutical, epidemiological,
statistical or other relevant background, and be capable of making
scientific analysis and evaluation of adverse drug reaction.
Chapter III Reporting and Process
Section I Basic Requirements
Article 15 Drug manufacturers, drug distributors and medical
institutions shall, when becomes aware of any suspected adverse drug
reaction , report through the adverse drug reaction monitoring
information network. If online reporting is not available, hardcopy
report shall be submitted to the local adverse drug reaction monitoring
body instead, and the local adverse drug reaction monitoring body shall
make online reporting accordingly.
The reported information shall be true, complete and accurate.
Article 16 Adverse drug reaction monitoring bodies at various levels
shall evaluate and manage the adverse drug reaction reporting and
monitoring information within their respective jurisdiction.
Article 17 Drug manufacturers, drug distributors and medical
institutions shall support the investigation on adverse drug reactions
or cluster adverse drug events conducted by drug regulatory authorities,
health administrative departments and adverse drug reaction monitoring
bodies, and shall provide necessary materials to facilitate the
investigation.
Article 18 Drug manufacturers, drug distributors and medical
institutions shall set up and maintain an adverse drug reaction
reporting and monitoring file.
Section II Individual Adverse Drug Reaction
Article 19 Drug manufacturers, drug distributors and medical
institutions shall collect adverse drug reaction actively, and shall,
when becomes aware of an adverse drug reaction, make detailed recording,
analyze and process, fill the “Adverse Drug

Reaction / Event Report Form” (see Exhibit 1) and then submit.

Article 20 For domestic drugs within the new drug monitoring period,
all the adverse drug reactions shall be reported. For other domestic
drugs, new and/or serious adverse drug reactions shall be reported.
For imported drugs, all the adverse drug reactions occurred within 5
years from the date of initial importation permission shall be reported;
and new and/or serious adverse drug reactions occurred after such 5-year
period shall be reported. Article 21 Drug manufacturers, drug
distributors and medical institutions shall report any new and/or
serious adverse drug reaction within 15 days after awareness. Death
cases shall be reported immediately, and other adverse drug reactions
shall be reported within 30 days. Follow-up information, if applicable,
shall be reported timely.
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Article 22 Drug manufacturers shall investigate death cases known to
them via collecting all basic information, the usage of all drugs, the
onset and treatment of adverse drug reaction, etc. They shall prepare an
investigation report within 15 days, and submit it to provincial adverse
drug reaction monitoring body where it is located. Article 23 Upon
discovery of a new and/or serious adverse drug reaction, individuals may
report to the treating physician, or to the manufacturer or distributor
of the drug or the local adverse drug reaction monitoring body. If
necessary, personal medical notes shall be provided.
Article 24 Adverse Drug reaction monitoring agencies at municipal /
county level shall review the authenticity, integrity and accuracy of
the adverse drug reaction reports received by them. The review and
evaluation of serious adverse drug reaction reports shall be completed
within 3 working days upon receipt thereof and that of other reports
shall be completed within 15 working days upon receipt thereof. Adverse
drug reaction monitoring agencies at municipal / county level t shall
investigate the death cases known to them via collecting all basic
information, the usage of drugs, the onset and treatment of adverse drug
reaction, etc. They shall prepare an investigation report within 15 days,
and submit it to the drug regulatory authorities and the health
administrative department at the same level as well as higher level
adverse drug reaction monitoring agency.
Article 25 Adverse drug reaction monitoring agencies at provincial
level shall complete the evaluation within 7 working days after
receiving the comments on serious adverse drug reaction from the lower
level adverse drug reaction monitoring agency.
For death cases, both the adverse drug reaction monitoring agency at
provincial level where the event occurs and the adverse drug reaction
monitoring agency at provincial level where the drug manufacturer is
located shall promptly carry out investigation and evaluation based on
the investigation report. If necessary, site investigation shall be
conducted. The evaluation results shall be submitted to the drug
regulatory department and the health administrative department at
provincial level as well as the National Adverse Drug Reaction
Monitoring Center.
Article 26 The National Adverse Drug Reaction Monitoring Center
shall promptly make analysis and evaluation of death cases, and submit
the evaluation results to the State Food and Drug Administration and the
Ministry of Health.
Section III Cluster Adverse Drug Events
Article 27 Drug manufacturers, drug distributors and medical
institutions shall, immediately upon awareness of any cluster adverse
drug event, report to the drug regulatory department, the health
administrative department and the adverse drug reaction monitoring
agency where it is located by telephone or fax. If necessary, bypassing
reporting may be made. Meanwhile, they shall fill out the “Group
Adverse
Drug Event Basic Information Form” (see Exhibit 2) and the
“Adverse Drug Reaction

/ Event Report F
orm” for every case, and submit it through the
adverse drug reaction monitoring information network.
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Article 28 Drug regulatory authorities at municipal / county level
shall, immediately upon knowledge of any group adverse drug reaction
event, carry out site investigations together with the health
administrative department at the same level. The investigation results
shall be promptly submitted level by level to food and drug
administration department and the health administrative department at
provincial level.
The Food and Drug administration department and the health
administrative department at provincial level shall jointly supervise
and guide the investigation conducted by the drug regulatory department
at municipal / county level. They shall make analysis and evaluation of
cluster adverse drug events, and carry out site investigation on cluster
adverse drug events which have great impact within their respective
jurisdiction. The evaluation and investigation results shall be promptly
submitted to the State Food and Drug Administration and the Ministry of
Health. The State Food and Drug Administration and the Ministry of
Health shall jointly carry out investigations on cluster adverse drug
events which have caused serious consequences and have great impact
across the nation.
Article 29 Drug manufacturers shall, immediately upon awareness of
any cluster adverse drug events, investigate onset of the cluster
adverse drug event, the usage of all drugs, the diagnosis and treatment
of the patient as well as the manufacture, storage, distribution of the
drug and any similar adverse events in the past. They shall prepare an
investigation report within 7 days and submit the same to the food and
drug administration department and the adverse drug reaction monitoring
agency at provincial level where it is located. Meanwhile, the drug
manufacturer shall promptly carry out self- examination to find out the
cause of the event. If necessary, the drug shall be suspended for
manufacturing, marketing and using and be recalled. Such actions shall