-
常
用
药
品
监
管
英
语
与
缩
略
语
——浙江省药品监督管理局政策法规处
一、监管英语
1.
《中华人民共和国药品管理法》
Drug Control Law of the
People's Republic of China
2.
药品生产企业管理
control over drug
manufacturers
3.
药品经营企业管理
control over drug
distributors
4.
医疗机构的药剂管理
control over medicines in
medical institutions
5.
药品管理
control over drugs
6.
药品包装的管理
control over drug packaging
7.
药品价格和广告的管理
control over drug price and
advertisement
8.
药品监督
inspection of drugs
9.
法律责任
legal liabilities
10.
药品标识
labels or marks of the drugs
11.
假药
counterfeit drugs
12.
劣药
inferior drugs
13.
药品检验机构
drug quality control laboratory
14.
药品的生产企业
drug manufacturers
15.
经营企业
drug distributors
16.
医疗机构
medical institutions
17.
药品监督管理部门
drug regulatory agency
18.
药品批准证明文件
drug approval documents
19.
行政处分
administrative sanctions
20.
刑事责任
criminal liabilities
21.
药品生产质量管理规范
Good Manufacturing Practice for
Pharmaceutical Products (GMP)
22.
药品经营质量管理规范
Good Supply Practice for Pharmaceutical
Products (GSP)
23.
药品生产许可证
Drug Manufacturing Certificate
24.
药品经营许可证
Drug Supply Certificate
25.
医疗机构制剂许可证
Pharmaceutical Preparation Certificate
for Medical Institution
26.
进口药品注册证书
Import Drug License
27.
临床试验
clinical trial
28.
新药证书
New Drug Certificate
29.
药品批准文号
Drug Approval Number
30.
在中华人民共和国境内从事药品的研制、生产、经营、使用和监督管理
的
单位或者个人，必须遵守《中华人民共和国药品管理法》
All
institutions
or
individuals
engaged
in
research,
production,
distribution,
use,
and administration and supervision of
drugs in the People's Republic of China shall
abide by drug control law of the
people's republic of China.
31.
国务院药品监督管理部门主管全国药品监督管理工作。
The
drug
regulatory
agency
of
the
State
Council
shall
be
responsible
for
drug
administration and
supervision nationwide.
32.
省、自治区、直辖市人民政府药品监督管理部门负责本行政区
域内的药品
监督管理工作。
The
drug
regulatory
agencies
of
the
governments
of
provinces,
autonomous
regions,
and
municipalities
directly
under
the
Central
Government
shall
be
responsible for drug
regulation in their administrative areas.
33.
药
品监督管理部门设置或者确定的药品检验机构，承担依法实施药品审批
和药品质量监督检
查所需的药品检验工作。
The
drug quality control laboratories established or
designated by drug regulatory
agencies
shall undertake the responsibility for drug
testing required for conducting
drug
review and approval and controlling drug quality
pursuant to the law.
34.
开办药品生产企业，须经企业所在地省、自治区、直辖市人民政府药品监
督管理部门批准并发给《药品生产许可证》
，凭《药品生产许可证》到工商行
政管理部门办理登记注册。
Any
newly
established
pharmaceutical
manufacturer
shall
be
subject
to
approval
by
the
local
drug
regulatory
agency
of
the
government
of
the
province,
autonomous region or municipality
directly under the Central Government and be
granted
the
Drug
Manufacturing
Certificate,
and,
with
the
certificate,
the
manufacturer
shall
be
registered
with
the
administrative
agency
for
industry
and
commerce.
35.
《药品生产许可证》应当标明有效期和生产范围，到期重新审查发证。
The term of validation and
the scope of manufacturing shall be noted in the
Drug
Manufacturing Certificate. For
renewal of the certificate on expiration,
reviewing
and approval again is
required.
36.
药品监
督管理部门批准开办药品生产企业，应当符合国家制定的药品行业
发展规划和产业政策，
防止重复建设。
When
giving approval to the newly-established
manufacturer, the drug regulatory
agency shall see to it that the
development programs and policies set by the State
for the pharmaceutical industry shall
be complied with so as to prevent duplicate
construction.
37
.
开办药品生产企业，必须具备以下条件：
（一）具有依法经过
资格认定的
药学技术人员、工程技术人员及相应的技术工人；
（
二）具有与其药品生产相
适应的厂房、设施和卫生环境；
（三）
具有能对所生产药品进行质量管理和质
量检验的机构、人员以及必要的仪器设备；
（四）具有保证药品质量的规章制
度。
Any drug manufacturer to be
established shall meet the following requirements:
(1)
stuffed with legally qualified
pharmaceutical and engineering professionals and
the
necessary
technical
workers;(2)
provided
with
the
premises,
facilities,
and
clear
environment required for drug
manufacturing; (3) having quality management and
control units and personnel capable of
quality management of and testing for drugs
to be produced and the necessary
instruments and equipment; and (4) establishing
rules and regulations to govern the
quality of drugs.
38.
药品生产企业必须按照国务院药品监督管理部门依据本法制定的《药品生
产质
量管理规范》组织生产。药品监督管理部门按照规定对药品生产企业是
否符合《药品生产
质量管理规范》的要求进行认证；对认证合格的，发给认
证证书。
Drug
manufacturers
shall
conduct
production
according
to
the
Good
Manufacturing Practice
Products (GMP) formulated by the drug regulatory
agency
of the State Council based on
this Law. The drug regulatory agency shall inspect
a
drug
manufacturer
as
to
its
compliance
with
the
GMP
requirements
and
issue
a
certificate to the manufacturer passing
the inspection.
39.
< br>除中药饮片的炮制外，药品必须按照国家药品标准和国务院药品监督管理
部门批准
的生产工艺进行生产，生产记录必须完整准确。
With the exception of the processing of
prepared slices of
Chinese
crude drugs, a
drug shall be produced
in
conformity
with
the
National Drug Standard and
with the production
processes approved by
the
drug regulatory
agency of the
State Council,
and the production records shall be complete and
accurate.
40.
药品生产企业改变影响药品质量的生产工艺的，必须报原批准部门审核批
准。
When
drug
manufacturers
make
any
change
in
the
production
process
that
may
affect the drug quality, they shall
submit the change to the original authority for
reviewing and approval.
41.
生产药品所需的原料、辅料，必须符合药用要求。
Active
pharmaceutical
ingredients
(API)
and
recipients
for
the
manufacture
of
pharmaceutical products
shall meet the requirements for medicinal use.
42.
药品生产企业必须对其生产的
药品进行质量检验。
Drug manufacturers
shall perform quality test of their products.
4
3.
不符
合国家药品标准或者不按照省、自治区、直辖市人民政府药品监督管
理部门制定的中药饮
片炮制规范炮制的，不得出厂。
No
products
that
do
not
meet
the
National
Drug
Standards
or
that
are
not
produced according to the processing
procedures for the prepared slices of Chinese
crude
drugs
formulated
by
the
drug
regulatory
agency
of
the
government
of
a
province,
autonomous
region,
or
municipality
directly
under
the
Central
Government may be released.
44.
经国务院药品监督管理部门或者国务院药品监督管理部门
授权的省、自治
区、直辖市人民政府药品监督管理部门批准，药品生产企业可以接受委托
生
产药品。
A drug manufacturer may not accept any
contract production of drugs unless it is
approved
by
the
drug
regulatory
agency
of
the
State
Council,
or
by
the
drug
regulatory
agency
of
the
government
of
a
province,
autonomous
region,
or
municipality
directly
under
the
Central
Government
authorized
by
the
drug
regulatory agency of the State Council.
45.
开办药品批发企业，须经企业
所在地省、自治区、直辖市人民政府药品监
督管理部门批准并发给《药品经营许可证》<
/p>
.
Any
newly
established
drug
wholesaler
shall
be
subject
to
approval
of
the
local
drug agency of the
government of the province, autonomous region or
municipality
directly under the Central
Government and be granted the Drug Supply
Certificate.
46.
开办药品零售企业，须经企业所在地县级以上地方药品监督管理部门批准
并发给《药品经
营许可证》
。
Any newly
established drug retailer shall be subject to
approval and be granted the
above
certificate by the local drug regulatory agency at
or above the county level.
47.
药品批发、零售企业凭《药品经营许可证》到工商行政
管理部门办理登
记注册。
With
the
Drug
Supply
Certificate
,
the
wholesaler
and
the
retailer
shall
be
registered with the administrative
agency for industry and commerce.
47.
无《药品经营许可证》的，不得经营药品。
No one is permitted to
distribute drugs without the certificate.
48.
《药品经营许可证》应当标明
有效期和经营范围，到期重新审查发证。
The valid period and the scope of
business shall be indicated in the Drug Supply
Certificate. For renewal of the
certificate upon expiration, reviewing and
approval
again is required.
49.
开办药品经营企业必须具备以下条件：
< br>
（一）具有依法经过资格认定的
药学技术人员；
（二）
具有与所经营药品相适应的营业场所、
设备、
仓储设施、
卫生环境；
（三）具
有与所经营药品相适应的质量管理机构或者人员；
（四）
具有保
证所经营药品质量的规章制度。
A
drug
distributor
to
be
established
shall
meet
the
following
requirements:(1)
staffed
with
legally
qualified
pharmaceutical
professionals;(2)
provided
with
the
business
operation
premises,
equipment,
warehouses,
and
clear
environment
required
for
drug
distribution;(3)
having
the
quality
control
units
or
personnel
adaptable the
drugs to be distributed; and(4) establishing rules
and regulations to
govern the quality
of the drugs to be distributed.
50.
药品经营企业必须按照国务院药品监督管理部门依据本法制定的《药品
经
营质量管理规范》经营药品。
Drug distributors shall conduct
business according to the Good Supply Practice for
Pharmaceutical
Products
(GSP)
set
by
the
drug
regulatory
agency
of
the
State
Council based on this Law.
51.
药品监督管理部门按照规定对药品经营企业是否符合《药
品经营质量管理
规范》的要求进行认证；对认证合格的，发给认证证书。
The drug regulatory
agency inspect a drug distributor as to its
compliance with the
GSP requirements,
and issue a certificate to the distributor passing
the inspection.
52.
< br>药品经营企业购进药品，必须建立并执行进货检查验收制度，验明药品合
格证明和
其他标识；不符合规定要求的，不得购进。
After
receiving
the
drug
purchased,
drug
distributors
shall
pass
the
established
examination
and
acceptance
system,
and
check
the
certificate
of
drug
quality,
labels and others marks; no drugs that
fail to meet the requirements are permitted
to be purchased.
53.
药品经营企业购销药品，必须有真实完整的购销记录。
Drug
distributors
shall
keep
a
real
and
perfect
records
of
purchasing
and
selling
drugs.
<
/p>
54.
购销记录必须注明药品的通用名称、剂型、规格、批号、有
效期、生产厂
商、购（销）货单位、购（销）货数量、购销价格、购（销）货日期及国务
院药品监督管理部门规定的其他内容。
In the record shall be
indicated the adopted name of drugs, dosage form,
strength
or size, batch number, date of
expiry, manufacturer, purchaser (or seller),
amount
of
the
drug
purchased
(or
sold),
purchase
or
selling
price,
date
of
purchase
(or
sale) , and other items
specified by the drug regulatory agency of the
State Council.
55.
药品经营企业销售中药材，必须标明产地。
Drug distributors shall indicate the
habitat of Chinese crude drugs to be sold.
56.
药品经营企业必须制定和执行
药品保管制度，采取必要的冷藏、防冻、防
潮、防虫、防鼠等措施，保证药品质量。
A
drug
distributor
shall
pass
the
established
system
for
drug
storage,
and
take
necessary
measures
to
ensure
drug
quality,
such
as
cold
storing,
protecting
from
being frozen and moisture and guarding
against insects and rodents.
57.
药品入库和出库必须执行检查制度。
An
examination
system
shall
be
followed
for
storing
drugs
in
warehouse
and
releasing them from warehouse.
58.
城乡集市贸易市场可以出售中
药材，国务院另有规定的除外。
Chinese
crude
drugs
may
be
sold
at
fairs
in
urban
and
rural
areas,
except
those
otherwise specified by the State
Council.
59.
城乡集市
贸易市场不得出售中药材以外的药品，
但持有
《药品经营许可证
》
的药品零售企业在规定的范围内可以在城乡集市贸易市场设点出售中药材以
外的药品。
No
drugs other than the Chinese crude drugs may be
sold at fairs in urban and rural
areas,
but
drug
retailers
holding
the
Drug
Supply
Certificate
may,
within
the
specified business scope, sell such
drugs at the stores they set up at the fairs.
60.
医
疗机构配制制剂，须经所在地省、自治区、直辖市人民政府卫生行政部
门审核同意，由省
、自治区、直辖市人民政府药品监督管理部门批准，发给
《医疗机构制剂许可证》
。
Dispensing
pharmaceutical preparations by a medical
institution shall be subject to
reviewing and permission by the health
administration agency of the government
of
the
province,
autonomous
region
or
municipality
directly
under
the
Central
Government, and upon approval by the
drug regulatory agency of the government.
A Pharmaceutical Preparation
Certificate for Medical Institution shall be
issued by
the above drug regulatory
agency.
61.
无《医疗机
构制剂许可证》的医疗机构，不得配制制剂。
No
medical
institution
is
permitted
to
dispense
pharmaceutical
preparations
without the
Pharmaceutical Preparation Certificate for Medical
Institution.
62.
《医疗机构制剂许可证》应当标明有效期，到期重新审查发证。
The term of validation
shall be noted in the Pharmaceutical Preparation
Certificate
for Medical Institution.
For renewal of the certificate upon expiration,
reviewing
and approval again is
required.
63.
医疗机
构配制的制剂，应当是本单位临床需要而市场上没有供应的品种，
并须经所在地省、自治
区、直辖市人民政府药品监督管理部门批准后方可配
制。
The pharmaceutical preparations to be
dispensed by the medical institution shall be
those satisfying the clinic need of the
institution but not available on the market. It
shall be subject to approval in advance
by the local drug regulatory agency of the
government of the province, autonomous
region or municipality directly under the
Central Government.
64.
医疗机构配制的制剂，不得在市场销售。
No pharmaceutical
preparations dispensed by medical institutions are
permitted to
be marketed.
<
/p>
65.
研制新药，必须按照国务院药品监督管理部门的规定如实报
送研制方法、
质量指标、药理及毒理试验结果等有关资料和样品，经国务院药品监督管理
部门批准后，方可进行临床试验。
A
full
description
of
a
new
drug
research
and
development
including
the
manufacturing
process,
quality
specifications,
results
of
pharmacological
and
toxicological study, and
the related data as well as the samples shall, in
accordance
with
the
regulations
of
the
drug
regulatory
agency
of
the
State
Council,
be
truthfully submitted to the above
agency for reviewing and approval.
66.
完成临床试验并通过审批的新药，由国务院药品监督管理部门批
准，发给
新药证书。
When a new drug has gone through
clinical trials and passed the reviewing, a New
Drug Certificate shall be issued upon
approval by the drug regulatory agency of the
State Council.
6
7.
药物的非临床安全性评价研究机构和临床试验机构必须分别执行药物非
临床研究质量管理规范、药物临床试验质量管理规范。
The institutions for non-
clinical safety evaluation and study and for
clinical study
institutions
shall
respectively
follow
the
Good
Laboratory
Practice
for
Non-Clinical Laboratory
Studies (GLP) and Good Clinical Practice (GCP).
68.
生产新药或者已有国家标准的
药品的，须经国务院药品监督管理部门批
准，并发给药品批准文号；但是，生产没有实施
批准文号管理的中药材和中
药饮片除外。
Production of a new drug or production
of a drug complying with National Drug
Standards
shall
be
subject
to
the
approval
by
the
drug
regulatory
agency
of
the
State
Council, and a drug approval number shall be
issued for it, with the exception
of
the Chinese crude drugs and the prepared slices of
Chinese crude drugs in which
no control
by approval number is exercised.
69.
实施批准文号管理的中药材、
中药饮片品种目录由国务院药品监督管理部
门会同国务院中医药管理部门制定。
The list of the Chinese crude
drugs and the prepared slices of the Chinese crude
drugs
to
be
controlled
by
the
approval
number
shall
be
compiled
by
the
drug
regulatory agency of the State Council,
jointly with the administrative agency for
traditional Chinese medicines of the
State Council.
70.
药品生产企业在取得药品批准文号后，方可生产该药品。
A
drug
manufacturer
is
permitted
to
produce
the
drug
only
after
an
approval
number has been
granted to it.
71.
药品必须符合国家药品标准。
Drugs shall comply with the National
Drug Standards.
72.
< br>国务院药品监督管理部门颁布的《中华人民共和国药典》和药品标准为国
家药品标
准。
The
Pharmacopoeia
of
the
People's
Republic
of
China
and
the
Drug
Standards
issued
by
the
drug
regulatory
agency
of
the
State
Council
shall
serve
as
the
National Drug Standards.
73.
国务院药品监督管理部门组织药典委员会，负责国家药品标准
的制定和修
订。
The drug regulatory agency of the State
Council shall organize a pharmacopoeia
commission, which shall be responsible
for formulating and revising the National
Drug Standards.
74.
国务院药品监督管理部门的药品检验机构负责标定国家药品标准品、对照
品。
The
drug
control
institution
affiliated
to
the
drug
regulatory
agency
of
the
State
Council is responsible for
standardizing the National Drug Standard Substance
and
Reference Substance.
75.
药品生产企业、药品经营企业、医疗机构必须从具有药品生产
、经营资格
的企业购进药品；但是，购进没有实施批准文号管理的中药材除外。
Drug manufacturers,
drug distributors and medical institutions shall
purchase drugs
from
pharmaceutical
enterprises,
which
are
qualified
for
production
and
distribution, with the exception of the
Chinese crude drugs in which no control by
approval number is exercised.
76.
国家对麻醉药品、精神药品、
医疗用毒性药品、放射性药品，实行特殊管
理。
The
State
exercises
special
control
over narcotic
drugs,
psychotropic
substances,
toxic drugs for
medical use and radioactive pharmaceuticals.
77.
国家实行中药品种保护制度。
The State adopts a protection system
for certain traditional Chinese medicines.
78.
国家对药品实行处方药与非处
方药分类管理制度。
The
State
adopts
a
system
of
classified
management
for
prescription
and
non-prescription drugs.
79.
药
品进口，须经国务院药品监督管理部门组织审查，经审查确认符合质量
标准、安全有效的
，方可批准进口，并发给进口药品注册证书。
Reviewing
the
drugs
to
be
imported
shall
come
of
the
jurisdiction
of
the
drug
regulatory
agency
of
the State
Council.
A
drug
is permitted to be imported
only
upon approval granted after confirming
that it conforms to the quality, safely and
efficiency through examination, and a
drug importation license shall be issued.
80.
国家实行药品储备制度。
The State adopts a policy for drug
storage for future use.
81.
国内发生重大灾情、疫情及其他突发事件时，国务院规定的部门可以紧急
调用企业药品。
When
major
disasters,
epidemic
situations
or
other
emergencies
occur
in
the
country,
the department designated by the State Council may
allocate drugs from
the enterprises to
meet the urgent need.
82.
禁止生产（包括配制）
、销售假药。
Production
(including
dispensing)
and
distribution
of
counterfeit
drugs
are
prohibited.
83.
有下列情形之一的，为假药：
A drug falling into the
following categories is deemed as a counterfeit
drug:
（一）药品所含成份与国家药品标准规定的成份不符的；
The ingredients in the drug
are different from those specified by the National
Drug
Standards;
（二）以非药品冒充药品或者以他种药品冒充此种药品的。
It is not the same drug
which is claimed by its name or in reality it is
not a drug at
all.
< br>84.
有下列情形之一的药品，按假药论处：
A drug falling into the
following categories shall be deemed as a
counterfeit drug:
（一）国务院药品监督管理部门规定禁止使用的；
I
t’s use is
prohibited by the provisions of the drug
regulatory agency of
the State
Council;
（二）依照本法必须批准而未经批准生产、
进口，或者依照本法必须检验而
未经检验即销售的；
It is produced or imported
without approval, or marketed without being
tested, as
required by the Law;
（三）变质的；
It is deteriorated;
（四）被污染的；
It is contaminated;
（五）使用依照本法必须取得批准文号而未取得批准文号的原
料药生产的；
It is
produced by using active pharmaceutical
ingredients without approval number
as
required by this Law;
（六）所标明的适应症或者功能主治超出规定范围的。
The indications or
functions indicated are beyond the specified
scope.
85.
禁止生产、销售劣药。
Production and distribution of drugs of
inferior quality are prohibited.
86.
药品成份的含量不符合国家药品标准的，为劣药。
< br>
A
drug
with
content not
up
to
the
National
Drug
Standards
is
a
drug of
inferior
quality.
87.
有下列情形之一的药品，按劣药论处：
A drug falling into the following
categories shall be deemed as a drug of inferior
quality:
（一）未标明有效期或者更改有效期的；
The date of expiry is not
indicated or is altered;
（二）不注明或者更改生产批号的；
The batch number is not indicated or is
altered;
（三）超过有效期的；
It is beyond the date of
expiry;
（四）直接接触药品的包装材料和容器未经批准的；
No
approval
certificate
is
obtained
for
the
immediate
packaging
material
or
container;
（五）擅自添加着色剂、防腐剂、香料、矫味剂及辅料的；
Colorants,
preservatives,
spices,
flavorings,
or
other
recipients
have
been
added
without authorization; or
（六）其他不符合药品标准规定的。
Other cases where the drug standards
are not complied with.
88.<
/p>
列入国家药品标准的药品名称为药品通用名称。已经作为药品通用名称
的，该名称不得作为药品商标使用。
A drug name listed in the National Drug
Standards is an adopted name in China.
Such an adopted name is not permitted
to be used as a trademark.
89.
药品生产企业、药品经营企业和医疗机构直接接触药品的工作人员，必须
每年进行健康检查。
Staff
members
of
drug
manufacturers,
drug
distributors
and
medical
institutions
who make a direct contact with drugs
shall receive physical examination annually.
90.
患有传染病或者其他可能污染
药品的疾病的，不得从事直接接触药品的工
作。
Those
who
suffer
from
infectious
diseases
or
any
other
diseases
that
may
cause
drug contamination are
not permitted to undertake any job in direct
contact with
drugs.
91.
直接接触药品的包装材料和容器，必须符合药用要求，
符合保障人体健
康、安全的标准，并由药品监督管理部门在审批药品时一并审批。
Immediate
packaging
materials
and
containers
shall
meet
the
requirements
for
medicinal use and comply with the
standards for ensuring human health and safety.
They along with the drugs shall be
subject to reviewing and approval by the drug
regulatory agency.
92.
药品包装必须按照规定印有或者贴有标签并附有说明书。
A label shall be printed or
stuck on the drug package with an insert sheet
attached
as required by regulations.
93.
标签或者说明书上必须注明药
品的通用名称、成份、规格、生产企业、批
准文号、产品批号、生产日期、有效期、适应
症或者功能主治、用法、用量、
禁忌、不良反应和注意事项。
In
the
label
or
insert
sheet
shall
be
indicated
the
adopted
name
of
the
drug,
its
ingredients,
strength,
manufacturer,
approval
number,
product
batch
number,
production
date,
date
of
expiry,
indications
or
functions,
usage,
dosage,
contraindications,
drug adverse reactions, and precautions.
94.
麻醉药品、精神药品、医疗用
毒性药品、放射性药品、外用药品和非处方
药的标签，必须印有规定的标志。
Specified
marks
shall
be
printed
in
the
label
of
narcotic
drugs,
psychotropic
substances,
toxic
drugs
for
medical
use,
radioactive
pharmaceuticals,
drugs
for
topical use, and non-
prescription drugs.
95.
药品的生产企业、经营企业和医疗机构必须执行政府定价、政府指导价，
不得以任何形式擅自提高价格。
Drug manufacturers, drug distributors
and medical institutions shall comply with
the prices fixed or guided by the
government. No one is permitted to raise prices in
any manner without authorization.
96.
禁止药品的生产企业、经营企
业和医疗机构在药品购销中帐外暗中给予、
收受回扣或者其他利益。
Drug manufacturers, drug
distributors and medical institutions are
prohibited from
secret
offering or accepting rake-offs or
other benefits (not shown in the account
book) in the course of purchasing and
selling drugs.
97.
禁止药品的生产企业、经营企业或者其代理人以任何名义给予使用其药品
的医疗机构
的负责人、药品采购人员、医师等有关人员以财物或者其他利益。
Drug manufacturers, drug distributors
or their agents are prohibited from offering,
under any pretence, money or goods of
value or other benefits to leading people,
drug
purchasers,
physicians,
or
other
related
persons
of
the
medical
institutions
where their drugs are purchased.
98.
药
品广告须经企业所在地省、自治区、直辖市人民政府药品监督管理部门
批准，并发给药品
广告批准文号；未取得药品广告批准文号的，不得发布。
Drug advertisement shall be subject to
approval by the drug regulatory agencies of
the government of the province,
autonomous region or municipality directly under
the Central Government where the
enterprise is located and an approval number of
drug advertisement shall he issued. No
one is permitted to release advertisement
without the approval number.
99.
处方药可以在国务院卫生行政
部门和国务院药品监督管理部门共同指定
的医学、药学专业刊物上介绍，但不得在大众传
播媒介发布广告或者以其他
方式进行以公众为对象的广告宣传。
Prescription
drugs
may
be
introduced
in
the
medical
or
pharmaceutical
professional
journals jointly designated by the administrative
agency of health and
the drug
regulatory agency of the State Council,
but their advertisements
are not
permitted to be released by
mass media or disseminated to the general public
by
other means.
100.
药品广告的内容必须真实、合法，以国务院药品监督管理部门批准的说
明书为准，不得含有虚假的内容。
The content of drug advertisement shall
be truthful and lawful, and shall be based
on the insert sheet approved by the
drug regulatory agency of the State Council.
The false content shall not be
contained in advertisement.
101.
药品广告不得含有不科学的表示功效的断言或者保证；不得利用国家机
关、医药科研单位、学术机构或者专家、学者、医师、患者的名义和形象作
证明。
No
unscientific
conclusion
or
guarantee
on
drug
efficacy
is
permitted
to
be
included in drug advertisement; names
or images of government agencies, medical
or pharmaceutical research
institutions, academic institutions, or experts,
scholars,
physicians
and
patients
are
prohibited
from
being
used
as
evidence
for
drug
advertising.
102
.
非药品广告不得有涉及药品的宣传。
Non-drug advertisements not
permitted to involve with drug promotion.
103.
药品监督管理部门进行监督
检查时，必须出示证明文件，对监督检查中
知悉的被检查人的技术秘密和业务秘密应当保
密。
When
people
from
drug
regulatory
agencies
conduct
supervision
and
inspection,
they
shall
show
their
identification
documents,
and
shall
keep
confidential
the
technical
and
business
secrets
of
the
persons
or
the
institutions
under
inspection
that have been
informed in the course of supervision and
inspection.
104.
药品监督管理部门根据监督检查的需要，可以对药品质量进行抽查检验。
Drug regulatory agencies may conduct
selective testing of drug quality in light of
the need of supervision and inspection.
105.
抽查检验应当按照规定抽样
，并不得收取任何费用。
Sampling for selective testing shall be
carried out according to relevant regulations,
and no fees are permitted to be charged
for sampling or testing.
<
/p>
106.
药品监督管理部门对有证据证明可能危害人体健康的药品
及其有关材料
可以采取查封、扣押的行政强制措施。
The drug regulatory agency shall take
administrative enforcement to seal or seize
the drugs and related materials proved
to be potentially harmful to human health
and shall.
107.
药品监督管理部门应当按照规定，依据《药品生产质量管理规范
》
、
《药
品经营质量管理规范》
，对经其认证合格的药品生产企业、药品经营企业进行
认证后的跟踪检
查。
Drug
regulatory agencies shall, in accordance with
regulations and on the basis of
the
GMP
and
GSP
,
make
the
follow-up
inspection
on
the
certified
drug
manufacturers and distributors.
108.
地方人民政府和药品监督管
理部门不得以要求实施药品检验、审批等手
段限制或者排斥非本地区药品生产企业依照本
法规定生产的药品进入本地
区。
With regard to the drugs produced
according to the provisions of this Law by drug
manufacturers not located in the
region, the local government and drug regulatory
agency are not permitted to restrict or
refuse their access to the region.
109.
国家实行药品不良反应报告
制度。
The
State
has
established
and
exercised
the
reporting
system
on
adverse
drug
reaction (ADR).
110.
未取得《药品生产许可证》
、
《药品经营许可证》或者《医疗机构制剂许
可证》生产药品、经营药品的，依法予以取缔
Without
Drug
Manufacturing
Certificate,
Drug
Supply
Certificate
or
Pharmaceutical
Preparation Certificate for Medical Institution,
the manufacturer or
distributor of drug
or medical institution shall be banned to produce
or distribute
drugs.
111.(1)
生产、销售假药的，没收违法生产、销售的药品和违法所得，
并处违
法生产、销售药品货值金额二倍以上五倍以下的罚款；
Where counterfeit drugs are produced or
sold, the drugs illegally produced or sold
and the illegal income shall be
confiscated, and a fine not less than two times
but
not more than five times the value
of the said drugs shall be collected.
(2)
有药品批准证明文件的予以撤销，并责令停产、停业整顿
；
The approval documents, if
any, shall be withdrawn and an order shall be
given to
suspend production or business
operation for rectification.
(3)
情节严重的，吊销《药品生产许可证》
、
《药品经营许可证》或者《医疗机
构制剂许可证》
；构成犯罪的，依法追究刑事责任。
If the circumstances are serious, the
Drug Manufacturing Certificate, Drug Supply
Certificate or Pharmaceutical
Preparation Certificate for Medical Institution
shall
be revoked. If a crime is
constituted, criminal liabilities shall be
investigated under
the law.
112.(1)
生产、销售劣药的，没收违法生产、销售的药品
和违法所得，并处违
法生产、销售药品货值金额一倍以上三倍以下的罚款；
Where inferior drugs are produced
or sold, the drugs illegally produced or sold and
the illegal income shall be
confiscated, and a fine not less than but not more
than
three times the value of the said
drugs shall also be collected.
(2)
情节严重的，责令停产、停业整顿或者撤销药品批准证明文件、吊销《药
品
生产许可证》
、
《药品经营许可证》或者《医疗机构制剂许可证
》
；
If the
circumstances are serious, an order shall be given
to suspend production or
business
operation
for
rectification,
or
the
drug
approval
documents
shall
be
withdrawn and the Drug
Manufacturing Certificate, the Drug Supply
Certificate, or
the Pharmaceutical
Preparation Certificate for Medical Institution
shall be revoked.
(3)
构成犯罪的，依
法追究刑事责任。
If a
crime is constituted, criminal liabilities shall
be investigated under the law.
113.
药品，是指用于预防、治疗、诊断人的疾病，有目的地调节人的生理机
能并规定有适应症或者功能主治、用法和用量的物质，包括中药材、中药饮
片、中成药、化学原料药及其制剂、抗生素、生化药品、放射性药品、血清、
疫苗、血液制品和诊断药品等。
Drugs refer to the products that are
used in the prevention, treatment and diagnosis
of human diseases and intended for the
regulation of the physiological functions of
human beings, with specifications of
indications, usage and dosage. They include
Chinese crude drugs, prepared slices of
Chinese crude drugs, traditional Chinese
medicines,
chemical
drug
substances
(API)
and
their
preparations,
antibiotics,
biochemical drugs, radioactive
pharmaceuticals, serum, vaccines, blood products,
and diagnostic agents.
114.
辅料，是指生产药品和调配处方时所用的赋形剂和附加剂。
Excipients
refer
to
the
vehicles
and
additives
intended
for
manufacturing
drug
dosage forms and
prescription dispensing.
11
5.
药品生产企业，是指生产药品的专营企业或者兼营企业。
Drug
manufacturers
refer
to
enterprises
exclusively
or
partly
engaged
in
drug
production.
116.
药品经营企业，是指经营药品的专营企业或者兼营企业。
Drug
distributors
refer
to
enterprises
exclusively
or
partly
engaged
in
drug
distribution.
117.
国务院药品监督管理部门负
责全国的医疗器械监督管理工作。
The drug
regulatory agency of the State Council is
responsible for supervision and
administration of medical devices
nationwide.
118.
国家对医疗器械实行分类管理。
The
State
shall
carry
out
the
policy
of
classification
administration
of
medical
devices.
119.
国家对医疗器械实行产品生产注册制度。
The State shall implement a
product registration system for manufacturing
medical
devices.
120.
生产第一类医疗器械，由设区的市级人民政府药品监督管理部门审查批
准，并发给产品生产注册证书。
Class
I
medical
devices
shall
be
inspected,
approved
and
issued
a
registration
certificate by
the drug regulatory agency of the government of
the municipalities
with districts.
121.
生产第二类医疗器械，由省
、自治区、直辖市人民政府药品监督管理部
门审查批准，并发给产品生产注册证书。
Class
Ⅱ
medical
devices
shall
be
inspected,
approved
and
issued
registration
certificates by
the
drug
regulatory
agency
of
provinces,
autonomous
regions and
municipalities directly of the Central
Government.
122.
生产第三类医疗器械，由国务院药品监督管理部门审查批准，并发给产
品生产注册证书。
生产第二类、第三类医疗器械，应当通过临床验证。
Class
Ⅲ
medical
devices
shall
be
inspected,
approved
and
issued
registration
certificates by
the drug regulatory agency directly under the
State Council.
123.
< br>医疗器械产品注册证书有效期四年。
The term
of validity for the registration certificate of
medical devices is four years.
124.
生产医疗器械，应当符合医疗器械国家标准；没有国家标准的，应当符
合医疗器械行业标准。
Medical
devices
manufactured
shall
meet
the
national
standard,
or
professional
standards when
there are no relevant national standards
available.
125.
医
疗器械的使用说明书、标签、包装应当符合国家有关标准或者规定。
The
instruction
for use,
label and package
of
medical devices
shall
comply
with
relevant standards or provisions in
China.
126.
医疗器械及
其外包装上应当按照国务院药品监督管理部门的规定，标明
产品注册证书编号。
The registration number of a
medical device shall be marked on the product
itself
and
on
the
external
package
according
to
the
provisions
of
the
drug
regulatory
agency of the State Council.
127.
开办第一类医疗器械生产企
业，应当向省、自治区、直辖市人民政府药
品监督管理部门备案。
For the manufacturing of class I
medical devices, it requires that the enterprise
file
a
record
with
the
drug
regulatory
agency
of
provinces,
autonomous
regions
or
municipalities directly
under the Central Government.
< br>128.
开办第二类、第三类医疗器械生产企业，
应当经省、自治区、直辖市人
民政府药品监督管理部门审查批准，并
发给《医疗器械生产企业许可证》
。
For the manufacturing of class
Ⅱ
and/or class
Ⅲ
medical
devices,
it requires
inspection
and
approval
by
the
drug
regulatory
agency
of
the
provinces,
autonomous
regions
and
municipalities
directly
under
the
Central
Government,
who will then
issue a Medical Device Manufacturing Enterprise
License.
129.
《医疗
器械生产企业许可证》有效期
5
年，有效期届满应当重新审查发
证。
The term of
validity of the Medical Device Manufacturing
Enterprise License is 5
years. Upon
expiration, re-inspection and license renewal
shall be conducted.
130.
医疗机构不得使用未经注册、无合格证明、过期、失效或者淘汰的医疗
器械。
Medical institutions
shall not use medical devices without
registration, or without
certificate
for qualified products, or they shall not use
medical devices which are
beyond their
expiry dates, of compromised effectiveness, or
obsolete.
131.
医疗
器械经营企业不得经营未经注册、无合格证明、过期、失效或者淘
汰的医疗器械。
Distribution
enterprises
shall
not
distribute
medical
devices
without
registration
certificates
or
certificates
for
qualified
products,
or
medical
devices
which
are
beyond their expiry dates, of
compromised effectiveness, or obsolete.
132.
医疗器械经营企业和医疗机
构应当从取得《医疗器械生产企业许可证》
的生产企业或者取得《医疗器械经营企业许可
证》的经营企业购进合格的医
疗器械，并验明产品合格证明。
Distribution
enterprises
and
medical
institutions
shall purchase
qualified
medical
devices
from
enterprises
having
a
Medical
Device
Manufacturing
Enterprise
License
or
Medical
Device
Distribution
Enterprise
License.
Their
certificate
of
qualified products shall be verified.
133.
医疗机构对一次性使用的医
疗器械不得重复使用；使用过的，应当按照
国家有关规定销毁，并作记录。
Medical
institutions
shall
not
re-use
medical
devices
labeled
for
single
use,
and
shall
destroy
them
after
use
with
record,
according
to
relevant
provisions
of
the
state.
134.
国家建立医疗器械质量事故
报告制度和医疗器械质量事故公告制度。
The
State
shall
establish
a
reporting
system
for
quality
accident
and
a
notifying
system of medical
devices.
135.
经国务
院药品监督管理部门会同国务院质量技术监督部门认可的检测机
构，方可对医疗器械实施
检测。
Only testing
institutions accredited by the drug regulatory
agency in conjunction
with the quality
and technical supervision agency of the State
Council may conduct
medical device
test.
136.
医疗器械检测
机构及其人员对被检测单位的技术资料负有保密义务，并
不得从事或者参与同检测有关的
医疗器械的研制、生产、经营和技术咨询等
活动。
Medical
device
testing
institutions
and
their
staff
members
shall
keep
strictly
confidential all technical information
provided by enterprises whose products are
being
tested,
and
shall
not
conduct
or
be
involved
in
research and
development,
manufacturing,
distribution,
and
technical
consultation
related
to
the
devices
tested.
-
-
-
-
-
-
-
-
-
上一篇：医学处方用到的英文简写
下一篇：史上最全药物化学专业英语词汇-双语版