常用药品监管词汇中英文

2021年2月1日发(作者：parent)

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.

< p>
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、

< p>
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.

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< /p>

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.

4 0.

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.

< p>
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.

43.

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。

< p>

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

< p>
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：

（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。< /p>

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.

< br>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.

< br>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.

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.

< p>
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.

6 5.

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.

67.

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).

< /p>

70.

药品生产企业在取得药品批准文号后，方可生产该药品。< /p>

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.

< br>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.

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；

It’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.

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86.

药品成份的含量不符合国家药品标准的，为劣药。

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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；