药学专业英语

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 affe

ct the drug quality, they shall submit the change to the original authority for

reviewing and approval.

药学专业英语

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 p

harmaceutical 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.

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 prod

uced according to the processing procedures for the prepared slices of Chinese

crude drugs formulated by the drug regulatory agency of the government of a pro

vince, 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 i

s approved by the drug regulatory agency of the State Council, or by the drug r

egulatory agency of the government of a province, autonomous region, or municip

ality directly under the Central Government authorized by the drug regulatory a

gency of the State Council.

药学专业英语

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 municipali

ty directly under the Central Government and be granted the Drug Supply Certifi

cate.

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 coun

ty 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 reg

istered 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.

药学专业英语

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 Suppl

y Certificate. For renewal of the certificate upon expiration, reviewing and ap

proval 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；

< br>（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 t

he business operation premises, equipment, warehouses, and clear environment re

quired for drug distribution;(3) having the quality control units or personnel

adaptable the drugs to be distributed; and(4) establishing rules and regulation

s 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 Stat

e Council based on this Law.

药学专业英语

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

< br>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 i

nspection.

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 establishe

d examination and acceptance system, and check the certificate of drug quality,

labels and others marks; no drugs that fail to meet the requirements are permi

tted 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 selli

ng drugs.

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, streng

th or size, batch number, date of expiry, manufacturer, purchaser (or seller),

药学专业英语

amount of the drug purchased (or sold), purchase or selling price, date of purc

hase (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 fr

om 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 rele

asing 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.

药学专业英语

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

< br>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 r

ural 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.

< br>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 subjec

t to reviewing and permission by the health administration agency of the govern

ment of the province, autonomous region or municipality directly under the Cent

ral Government, and upon approval by the drug regulatory agency of the governme

nt. A Pharmaceutical Preparation Certificate for Medical Institution shall be i

ssued 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 wit

hout 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。

药学专业英语

The term of validation shall be noted in the Pharmaceutical Preparation Certifi

cate for Medical Institution. For renewal of the certificate upon expiration, r

eviewing 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 shal

l be those satisfying the clinic need of the institution but not available on t

he market. It shall be subject to approval in advance by the local drug regulat

ory 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.

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。< /p>

A full description of a new drug research and development including the manufac

turing process, quality specifications, results of pharmacological and toxicolo

gical study, and the related data as well as the samples shall, in accordance w

药学专业英语

ith the regulations of the drug regulatory agency of the State Council, be trut

hfully 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 Ne

w 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 N

on-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 S

tandards 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 exce

ption of the Chinese crude drugs and the prepared slices of Chinese crude drugs

in which no control by approval number is exercised.

药学专业英语

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

< br>中医药管理部门制定。

The list of the Chinese crude drugs and the prepared slices of the Chinese crud

e drugs to be controlled by the approval number shall be compiled by the drug r

egulatory agency of the State Council, jointly with the administrative agency f

or 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 num

ber 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.

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 issu

ed by the drug regulatory agency of the State Council shall serve as the Nation

al 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。

药学专业英语

The drug regulatory agency of the State Council shall organize a pharmacopoeia

commission, which shall be responsible for formulating and revising the Nationa

l 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 St

ate Council is responsible for standardizing the National Drug Standard Substan

ce 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 d

rugs from pharmaceutical enterprises, which are qualified for production and di

stribution, with the exception of the Chinese crude drugs in which no control b

y approval number is exercised.

76.< /p>

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 substance

s, toxic drugs for medical use and radioactive pharmaceuticals.

77.

国家实行中药品种保护制度。

药学专业英语

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- pre

scription 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 r

egulatory 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 iss

ued.

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。

药学专业英语

When major disasters, epidemic situations or other emergencies occur in the cou

ntry, the department designated by the State Council may allocate drugs from th

e 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 pro

hibited.

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 d

rug:

（一）国务院药品监督管理部门规定禁止使用的；

药学专业英语

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 numb

er 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。

药学专业英语

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 infer

ior 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 con

tainer;

（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 add

ed 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.

药学专业英语

88.

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。