常用药品监管英语与缩略语

zhaoyuyong · 发表于 2007-4-27 17:13:32

常用药品监管英语与缩略语
                        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.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.

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。
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》.
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：（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.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.

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.

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.

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).

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.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.

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.

86.药品成份的含量不符合国家药品标准的，为劣药。
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.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.

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.

115.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.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.

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.

137.对已经造成医疗器械质量事故或者可能造成医疗器械质量事故的产品及有关资料，县级以上地方人民政府药品监督管理部门可以予以查封、扣押。
For products having caused or which may potentially cause quality incidents, the drug regulatory agency of the governments at county level and above shall have the right to check, seal up and detain them together with materials related.

138.医疗器械广告应当经省级以上人民政府药品监督管理部门审查批准；未经批准的，不得刊登、播放、散发和张贴。
Advertisements of medical devices shall be reviewed and approved by the drug regulatory agency of governments at provincial level and above, and shall not be published, broadcast, circulated or posted before the approval.

139.医疗器械广告的内容应当以国务院药品监督管理部门或者省、自治区、直辖市人民政府药品监督管理部门批准的使用说明书为准。
The contents of the advertisements shall be based on the instruction for use approved by the drug regulatory agency of the State Council or the drug regulatory agency of the governments of provinces, autonomous regions and municipalities directly under the Central Government.

140.医疗器械监督管理人员滥用职权、徇私舞弊、玩忽职守，构成犯罪的，依法追究刑事责任；尚不构成犯罪的，依法给予行政处分。
In cases where personnel engaged in the supervision and administration of medical devices abuse their power, and pursue personal benefits by deceiving, or neglecting their duties, in violation of provisions of the Regulation, to the extent to which crimes are committed, criminal liabilities shall be investigated and handled pursuant to the law. For those not committing crimes, disciplinary punishment shall be given pursuant to the relevant regulations.

141.第一类医疗器械是指，通过常规管理足以保证其安全性、有效性的医疗器械。
Class I Medical Devices are those for which safety and effectiveness can be ensured through a routine administration.

142.第二类医疗器械是指，对其安全性、有效性应当加以控制的医疗器械。
Class Ⅱ Medical Devices are those for which further control is required to ensure their safety and effectiveness.

143.第三类医疗器械是指，植入人体；用于支持、维持生命；对人体具有潜在危险，对其安全性、有效性必须严格控制的医疗器械。
Class Ⅲ Medical Devices are those which are implanted into the human body, or used for life support or sustenance, or with some potential risk to the human body and thus shall be strictly controlled in respect to safety and effectiveness.

144.医疗器械，是指单独或者组合使用于人体的仪器、设备、器具、材料或者其他物品，包括所需要的软件；其用于人体体表及体内的作用不是用药理学、免疫学或者代谢的手段获得，但是可能有这些手段参与并起一定的辅助作用；其使用旨在达到下列预期目的：
“Medical devices” refer to : any instrument, equipment apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application. It does not achieve its principal action in or on the human body by means of pharmacology, immunology or metabolism, but may be assisted in its function by such means; the use of medical devices is to achieve the following intended objectives:
（一）对疾病的预防、诊断、治疗、监护、缓解；
（1）prevention, diagnosis, treatment, monitoring or alleviation of disease;
（二）对损伤或者残疾的诊断、治疗、监护、缓解、补偿；
（2）diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap conditions;
（三）对解剖或者生理过程的研究、替代、调节；
（3）investigation, replacement or regulation for anatomical or a physiological process;
（四）妊娠控制。
（4）control of conception.

145.医疗器械监督管理条例
The Regulation for the Supervision and Administration of Medical Devices.

146.注册证书
Registration certificates.

147.医疗器械生产企业许可证
Medical Device Manufacturing  Enterprise  License.

148.医疗器械经营企业许可证
Medical Device Distributing Enterprise License.

常用英文缩写

英文缩写英  文中文翻译
一、机构
CAC Codex Alimentarius Committee (国际)食品法典委员会
CBER FDA Center for Biologics Evaluation
and Research (美国)FDA生物制品评价与研究中心
CCD Certification Committee for Drugs (国家食品药品监督管理局)药品认证管理中心
CDC Centers for Disease Control (美国)疾病控制中心
CDE Center for Drug Evaluation (国家食品药品监督管理局)药品审评中心
CDER FDA Center for Drug Evaluation and
Research (美国)FDA药品评价与研究中心
CDR Center for Drug Reevaluation (国家食品药品监督管理局)药品评价中心
CDRH FDA Center for Devices and
Radiological Health (美国)FDA医疗器械和辐射健康中心
CFSAN FDA Center for Food Safety and
Applied Nutrition (美国)FDA食品安全和应用营养中心
CMA Chinese Medical Association 中华医学会
CNAO National Audit Office of the People's
Republic of China 中华人民共和国审计署
CNMA China Nonprescription Medicines
Association 中国非处方药协会
CPA China Pharmaceutical Association 中国药学会
CPMA China Preventive Mediceine
Association 中华预防医学会
CVM FDA Center for Veterinary Medicine (美国)FDA兽药中心
DEA Drug Enforcement Administration (美国)毒品强制执行管理局
DHHS Department of Health and Human
Services (美国)健康和人类服务部
EFSA European Food Safety Authority 欧洲食品安全局
EMEA European Agency for the Evaluation of Medicinal Products 欧洲药品评价署
EPA Environmental Protection Agency (美国)环境保护署
EU European Union 欧盟
FAO United Nations Food and Agricultural Organization 联合国粮农组织
FDA Food and Drug Administration (美国)食品药品管理局
FSIS Food Safety Inspection Service
(USDA) (美国农业部)食品安全检查服务局
FTC Federal Trade Commission (美国)联邦贸易委员会
ICH International Conference on
Harmonization 国际(药品注册)协调会议
IMIC International Medical Information
Center 国际医学信息中心
INCB International Narcotics Control Board 国际麻醉药品管制局
IOM Institute of Medicine (美国国家科学院)医学研究所
IPF International Pharmaceutical
Federation 国际制药联合会
IRC International Red Cross 国际红十字会
IRCC International Red Cross Conference 国际红十字大会
ISO International Standards Organization 国际标准化组织
IVDC China Institute of Veterinary Drug
Control 中国兽医药品监察所
JIFSAN Joint Institute for Food Safety and
Applied Nutrition (美国FDA)食品安全和应用营养联合研究所
KFDA Korea Food and Drug Administration (韩国)食品药品管理局
MHLW Ministry of Health, Labour and Welfare (日本)厚生劳动省
MII China Ministry of Information Industry 中华人民共和国信息产业部
MOF Ministry of Finance People's Republic of China 中华人民共和国财政部
MoH Ministry of Health P.R.China 中华人民共和国卫生部
MOST Ministry of Science and Technology of
the People's Republic of China 中华人民共和国科学技术部
NBS National Bureau of Statistics of China 国家统计局
NCI National Cancer Institute (美国)国家癌症研究所
NCTR FDA National Center for Toxicological
Research (美国)FDA国家毒理学研究中心
NIAID National Institute of Allergy and
Infectious Diseases (美国)国家过敏症和传染病研究所
NICPBP National Institute for the Control of
Pharmaceutical and Biological
Products 中国药品生物制品检定所
NIDA National Institute on Drug Abuse (美国)国家药物滥用研究所
NIH National Institute of Health (美国)国家健康研究所
ORA FDA Office of Regulatory Affairs (美国)FDA监管事务办公室
PHS Public Health Service (美国)公众健康服务局
PRC People's Republic of China 中华人民共和国
SAIC State Administration For Industry &
Commerce 国家工商行政管理总局
SAMHSA Substance Abuse and Mental Health
Services Administration (美国)物质滥用和精神健康服务管理局
SATCM State Administration of Traditional
Chinese Medicine (中国)国家中医药管理局
SETC State Economic and Trade
Commission，PRC 中华人民共和国国家经济贸易委员会
SFDA State Food and Drug Administration (中国)国家食品药品监督管理局
SIPO State Intellectual Property Office of the People's Republic of China 国家知识产权局
TFDA Thailand Food and Drug
Administration (泰国)食品药品管理局
TGA Therapeutic Goods Administration (澳大利亚)治疗产品管理局
UK United Kingdom (大不列颠)联合王国
USDA Unites States Department of
Agriculture 美国农业部
WHO United Nations World Health
Organization (联合国)世界卫生组织
WTO World Trade Organization 世界贸易组织
ZDA Zhejiang Drug Administration 浙江省药品监督管理局
　 The Ministry of Agriculture of the
People's Republic of China 中华人民共和国农业部
　 Ministry of Commerce of the People's
Republic of China 中华人民共和国商务部
　 National Population and Family
Planning Commission of China 国家人口和计划生育委员会
　 State Administration of Taxation of
China 国家税务总局
　 Chinese Center for Disease Control
and Prevention 中国疾病预防控制中心
　 National Center for Health Inspection
and Supervision 卫生部卫生监督中心
　 The National Center for Drug
Screening 国家新药筛选中心
　 National Committee on the Assessment
of the Protected Traditional Chinese
Medicinal Products P.R.C. 国家中药品种保护评审委员会
　 National Development and Reform
Commission 中华人民共和国国家发展和改革委员会
　 Ministry of Justice P.R.C 中华人民共和国司法部
二、国家、首都和地区(部分)
AUST Australia 澳大利亚
　 Canberra 堪培拉
Aut Austria 奥地利
　 Wienna 维也纳
Bra Brazil 巴西
　 Brasilia 巴西利亚
Brit Britain 英国
　 London 伦敦
Can Canada 加拿大
　 Ottawa 渥太华
Ch China 中国
　 Beijing 北京
Fra France 法国
　 Paris 巴黎
Ger Germany 德国
　 Berlin 柏林
Hol Holland 荷兰
　 Amsterdam 阿姆斯特丹
Ind India 印度
　 New Delhi 新德里
Indon Indonesia 印度尼西亚
　 Jakarta 雅加达
Ir Irag 伊拉克
　 Baghdad 巴格达
Ir Ireland 爱尔兰
　 Dublin 都柏林
Ital Italy 意大利
　 Roma 罗马
J Japan 日本
　 Tokyo 东京
Kor Korea 朝鲜
　 Pyongyang 平壤
Kuw Kuwait 科威特
　 Kuwait City 科威特城
Pg Portugal 葡萄牙
　 Lisbon 里斯本
Pna Panama 巴拿马
　 Ciudad de Panama 巴拿马城
Pol Poland 波兰
　 Warsaw 华沙
Russ Russian 俄罗斯
　 Moscow 莫斯科
Sp Spanish 西班牙
　 Madrid 马德里
SIN Singapore 新加坡
Swit Switzerland 瑞士
　 Berne 伯尔尼
U.S. United States of America 美国
　 Washington 华盛顿
Mac Macao 澳门
Mil Milan (意)米兰
Tib Tibet 西藏
TW Taiwan 台湾
HK Hongkong 香港
Hma Hiroshima (日)广岛
EU European Union 欧盟
三、货币(部分)
AUD Australia Dollar 澳洲元
CAD Canada Dollar 加拿大元($)
Fr. Franc 法郎
RMB Renminbi Yuan 人民币元（￥）
EUR Euro 欧元
GBP British Pound 英镑(￡)
HKD Hong Kong Dollar 港元($)
JPY Japanese Yen 日圆（￥）
Lit Lira 里拉
M Mark 马克
MYR Malaysian Ringgit 马来西亚元($)
NZD New Zealand Dollar 纽西兰元
SGD Singapore yuan 新加坡元($)
SWK Swedish Krona 瑞典克朗
THB Thai Baht 泰国币
TWD Taiwan new Dollar 新台币
USD U.S.dollar 美元（＄）
四、医学药学名词
510(k) Premarket Notification For Medical Devices Substantially Equivalent To Products Already On The Market 对实质等效于已上市产品的医疗器械的上市前通知
AAD Atherosclerotic Arterial Disease 动脉粥样硬化病
AADA Abbreviated Antibiotic Drug
Application 简化抗生素药品申请
AA-DS Acute Arthritis-Dermatitis Syndrome 急性关节炎－皮炎综合症
AAE Acute Allergic Encephalitis 急性过敏性脑炎
AAM Acute Aseptic Meningitis 急性无菌性脑膜炎
AAR Active Avoidance Reaction 主动回避反应
AARIT Antigen-Antibody Reaction Inhibition
Test 抗原－抗体反应抑制试验
AAT Acute Abdominal Tympany 急性腹胀
ABE Acute Bacterial Endocarditis 急性细菌性心内膜炎
ABMR Autologous Bone Marrow Rescue 自身骨髓解救
ABO Blood Classification System 血液分类系统
ABP Antigen-Blinding Protein 抗原结合蛋白
ABS Aging Brain Syndrome 老年脑综合症
ACAD Asymptomatic Coronary Artery Disease 无症状性冠状动脉疾病
A-CAH Autoimmune Chronic Active Hepatitis 自身免疫慢性活动性肝炎
ACPP Adrenocortical Polypeptide 肾上腺皮质多肽
ADE Adverse Drug Event 不良药品事件；药品不良事件
ADR Adverse Drug Reaction 不良药品反应；药品不良反应
ADR Adverse Drug Report 不良药品报告；药品不良反应报告
AERS Adverse Events Reporting System 不良事件报告系统
AHG Antihemophilic Globulin 抗血友病球蛋白
AHA Acute Hemolytic Anemia 急性溶血性贫血
AHAB American Health Information Bank 美国卫生信息库
AIDS Acquired Immune Deficiency Syndrome 获得性免疫缺乏综合症；爱滋病
ANDA Abbreviated New Drug Application 简化新药申请
ASCT Autologous Stem Cell Transplan-Tation 自体干细胞移植
ATP Adenosine Triphosphate 三磷酸腺甘
BIMO Bioresearch Monitoring 生物研究监测
BLA Biologic License Application 生物制品许可申请
BP British Pharmacopoeia 《英国药典》
BSE Bovine spongiform encephalopathy
(mad cow disease) 牛海绵状脑病(疯牛病)
CGMPs Current good manufacturing practices 现行良好制造规范；现行药品生产质量管理规范
CJD Creutzfeldt-Jakob disease 克雅氏病
COS Certificate of Suitability (《欧洲药典》)适用性证书
CP The Pharmacopoeia of the PRC 《中国药典》
CY Calendar year (January - December) 历年(1月—12月)
D/S Dextrose/saline 葡萄糖盐水
DCBF Dyamic cardiac blood flow 心动态流血
DCPC Deacetyl cephalosporin C 脱乙酰头孢菌素C
DD Dangerous drug 危险药品
DDA Dangerous Drugs Act 危险药品法
DDC Dangerous drug cabinet 危险药品柜
DDD Defined daily dose 规定的每日剂量
DDp Drug dependence 药物依赖性(药瘾)
DD-SF Delayed dose sensitive feedback 药物剂量延迟反馈
DDx Differential diagnosis 鉴别诊断
DE Drug evaluation 药品评价
DE Dose equivalent 等价剂量；剂量当量（放射）
DI Drug interactions 药物相互作用
DIC Drug information center 药品信息中心
DID Drug induced disease 药品诱发疾病；药源性疾病
DIF Dose increase factor 剂量增加因素
DME Drug-metabolizing enzyme 药物代谢酶
DMF Durg master file 药品主文件
DNA Deoxyribonucleic acid 脱氧核糖核酸
DSHEA Dietary Supplement Health and
Education Act 《饮食补充剂健康与教育法》
DUR Drug utilization review 药物利用评价
DUR Drug use review 药物使用评论
EFA Essential fatty acid 必需脂肪酸
EHC Essential hypercholesterolemia 原发性高胆固醇血症
EIA Enzyme immunoassay 酶免疫分析
ELA Establishment license application 机构许可申请
ELISA Enzyme-linked immunosorbent assay 酶联免疫吸附测定
EP European pharmacopoeia 《欧洲药典》
FD&C Act Federal Food, Drug and Cosmetic Act 《联邦食品、药品和化妆品法》
FDAMA Food and Drug Administration
Modernization Act of 1997 《1997年食品药品管理局现代化法》
FIA Fluorescence immunoassay 荧光免疫分析
FLQ Fluoroquinolone 氟喹诺酮
FPIA Fluorescence polarization immunoassay 荧光偏振免疫分析
FPLA Fair Packaging and Labeling Act 《公平包装与标识法》
FSOT Fused-silica open tubular column 熔融二氧化硅空心柱
FY Fiscal year (October - September) 财政年度(10月—9月)
GAPs Good agricultural practices 良好农业规范；中药材生产质量管理规范
GATT General Agreement on Tariffs and Trade 《关税与贸易总协定》
GCP Good clinical practice 良好临床规范；药品临床研究质量管理规范
GDP Good dispensing practice 良好调配规范；
GF Growth factor 生长因子
GLP Good laboratory practice 良好实验室规范；药品非临床研究质量管理规范
GMP Good manufacturing practices 药品生产和管理规范
GPP Good pharmacy practice 良好药房规范；医疗机构制剂配制管理规范
GPSP Good Post-marketing Surveillance
Practice 良好上市后监督规范；上市药品监督规范
GRAS Generally Recognized as Safe food
ingredients 公认安全的食品成分
GSP Good supplying practice 良好供应规范；药品经营质量管理规范
HACCP Hazard Analysis Critical Control Points (a quality assurance and inspection technique) 危害分析与关键控制点(一种质量保证和检查技术)
HAR Hemoagglutination reaction 血细胞凝集反应
HARM Heparin assay rapid method 肝素快速测定方法
HAs Highest asymptomatic dose 最大无症状剂量
HIV Human immunodeficiency virus 人免疫缺陷病毒
HPLC High-performance liquid
chromatography 高效液相色谱法
HTD Human therapeutic dose 人治疗剂量
IAIS Insulin autoimmune syndrome 胰岛素自体免疫综合症
IAN Idiopathic aseptic necrosis 自发性无菌性坏死
IBQ Illness behavior questionnaire 病态行为调查表
IBV Infectious bronchitis vaccine 感染性支气管炎疫苗
ICF Intensive care facility 重症监护设施
ICF Intensive care facility 重症监护设施
Icx Immune complex 免疫复合体
IIS Intensive immunosuppression 加强免疫抑制（法）
IMBC Indirect maximum breathing capacity 间接最大呼吸量
IND Investigational new drug 研究用新药
INN International nonproprietary name 国际非专有药名
IRTU Integrating regulatory transcription unit 整合调解转录单位
IS Immune serum 免疫血清
ISD Immunosuppressive drug 免疫抑制剂
IT Information technology 信息技术
IU International unit 国际单位
Ksp Solubility product 可溶性产物
LACF Low acid canned foods 低酸罐装食品
LAN Local area network 局域网；局部区域网络
LC50 Median lethal concentration 半数致死浓度
LD50 Median lethal dose 半数致死量
LFD Least fatal dose 最低致死剂量
LIE Liquid ion evaporation 液体离子蒸发
M&M Morbidity and mortality 发病率和死亡率
MAO Maximal acid output 最大酸输出量
MAR    Maximal aggregation ratio 最大聚集率
MAS Medical advisory service 医疗咨询服务
MB Microbiological assay 微生物鉴定
MDG Mean diastolic gradient 平均收缩梯度
MDR Medical Device Reporting system 医疗器械报告系统
MIC Minimun inhibitory concentration 最低抑菌浓度
MIC50 50％ minimun inhibitory concentration 50％最低抑菌浓度
MIC90 90％ minimun inhibitory concentration 90％最低抑菌浓度
MID Minimum infective dose 最小感染剂量
MIP Maximum inspiratory pressure 最大吸气压
MLC Minimum lethal concentration 最小致死浓度
MLD Minimum lethal dose 最小致死量
MMEF Maximum midexpiratory flow 最大呼气中期流量
MND Minimum necrosing dose 最小坏死剂量
MOU Memorandum of Understanding 谅解备忘录
MPO Maximum power output 最大能量的输出量
MQSA Mammography quality standards act 《乳房X线造影术质量标准法》
MRA Mutual recognition agreement 互认协议
MRFIT Multiple risk factor interviention trial 多种危险因子干扰试验
MRSA Methicillin resistant Staphylococcus aureus 抗甲氧西林金黄色葡萄球菌
MTC Maximum talerated concentration 最大耐受浓度
MTD Maximum tolerated dose 最大耐受剂量
MTI Minimum time interval 最低间隔时间
N.F. National formulary 《(美国)国家处方集》
NAFTA North atlantic free trade agreement 《北大西洋自由贸易协议》
NARMS National antimicrobial resistance
monitoring system 国家耐抗菌素监测系统
NCP Noncollagen protein 非胶原蛋白
NDA New drug application 新药申请
NDR Normal daily requirement 每日正常需要量
NETD Non-equilibrium temperature difference 非平衡温差
NFD Nonfatal disease 非致死性疾病
NGF Nerve growth factor 神经生长因子
NIBP Noninvasive blood pressure 非侵入性血压
NID Nonimmunological disease 非免疫性疾病
NIDA Nutritional iron defeciency anemia 营养性缺铁性贫血
NIR Nosocomial infection rate 医院感染率
NK Natural killer (cell) 自然杀伤细胞
NKDA No known drug allergies 未知的药物过敏症
NKFA No known food allergies 未知的食物过敏症
NLEA Nutrition Labeling and Education Act 《营养标识与教育法》
NME New molecular entity 新分子实体
NMR Neonatal mortality rate 新生儿死亡率
NNF Nonnutritive fiber 无营养纤维
NNS Nonneoplastic syndrome 非肿瘤性综合症
NOED Non-observed effect dose 无毒性效应剂量
NOHL Non-organic hearing loss 非器质性耳聋
NP Nordic pharmacopoeia 《北欧药典》
NPD Normal protein diet 正常蛋白饮食
NPN Non-protein nitrogen 非蛋白氮
NQAA Nonquantitative absorption assay 非定量吸收测定
OASIS Operational and Administrative System for Import Support 进口支持的运作和管理系统
OTC Over the counter drug (Nonprescription drugs) 放在柜台上的药品(非处方药)
OTC Over-the-counter 上柜；非处方
PAGE Polyacrylamide gel electrophoresis 聚丙烯酰胺凝胶电泳
PCA Principal component analysis 主成分分析
PCR Polymerase chain reaction 聚合酶链反应
PDMS Plasma desorption mass spectrometry 等离子体解吸质谱法
PDUFA Prescription Drug User Fee Act of 1992 《1992年处方药用户费法》
PE Pharmacoeconomica 药物经济学
Ph Gal Pharmacopoeia galisa 《法国药典》[拉]
Ph J Pharmacopoeia japonica 《日本药典》
PHA Phytohemagglutinin 植物凝集素
PhI Pharmacopoeia internationalis 《国际药典》[拉]
PL Phospholipid 磷脂
PLA Product license application 产品许可申请
PMA Premarket Approval (Application to
market medical device that requires
premarket approval) 上市前批准(要求上市前批准的医疗器械的上市申请)
PMS Postmarking surveilance 上市后监督
PPP Platelet poor plasma 贫血小板血浆
PRP Platelet rich plasma 富血小板血浆
PT Prothrombin time 凝血酶原时间
QA Quality assurance 质量保证
QC Quality control 质量控制
QSAR Quantitative structure activity
relationship 定量构效关系
R&D Research and development 研究与开发
RA Rheumatoid arthritis 类风湿性关节炎
RCHSA Radiation Control for Health and Safety
Act 《为健康和安全的辐射控制法》
RF Replicating form 复制性
RIA Radioimmunoassay 放射免疫测定
RNA Ribonucleic acid 核糖核酸
SAB Serum albumin 血清白蛋白
SARS Severe acute respiratory syndrome 严重急性呼吸道综合症
SCE Sister chromatid exchange 姐妹染色体互换
SE Salmonella enteriditis 沙门氏菌
SOP Standard operating procedure 标准操作规程
TB Tuberculosis 结核病
TD50 Median toxic dose 半数中毒量
TPN Total parenteral nutrition 全肠外营养
TQC Total quality control 全面质量控制
USP The united states pharmacopoeia 《美国药典》
五、传染病
AIDS Acquired immune deficiency syndrome 获得性免疫缺陷综合症；艾滋病
cho Cholera 霍乱
Cp Chicken pox 水痘
diph Diphtheria 白喉
ECM Epidemic cerebrospinal meningitis 流行性脑脊髓膜炎
EHF Epidemic hemorrhagic fever 流行性出血热
Gono Gonorrhea 淋病
IB Infectivity bronchitis 感染性支气管炎
JBE Japanese B encephalitis 流行性乙型脑炎；日本B型脑炎
P Plague 鼠疫
Polio Poliomyelitis 脊髓灰质炎；小儿麻痹症
PT Pulmonary tuberculosis 肺结核
Rab Rabies 狂犬病
SARS Severe acute respiratory syndrome 严重急性呼吸道综合症
SF Scarlet fever 猩红热
SY Syphilis 梅毒
TB Tuberculosis 结核病
Ty Typhoid 伤寒
VH Viral hepatitis 病毒性肝炎
Vl Visceral leishmaniasis 黑热病，又称内脏利什曼病
WC Whooping cough 百日咳
　 Anthracnose 炭疽病
　 Shigellosis 细菌性痢疾，志贺菌病
　 Paratyphoid fever 副伤寒
　 Measles；rubeola；morbill 麻疹
　 Typhus fever；Typhus 斑疹伤寒
　 Paludism；malaria 疟疾
　 Breakbone fever；dengue fever 登革热
　 Tetanus of newborn 新生儿破伤风
六、化验单
ALB Albumin 白蛋白
ALP Alkaline phosphatase 碱性磷酸酶
APO Apolipoprotein 载脂蛋白
BIL Bilirubin 胆红素
BT Bleeding time 出血时间
CHO Cholesterol 胆固醇
CT Clotting time 血块形成时间
CT Coagulation time 凝固时间
D-BIL Direct bilirubin 直接胆红素
er Erythrocyte 红细胞
GLU Glucose 葡萄糖
GOT Glutamic-oxal(o)acetic transaminase 谷草转氨酶
GPT Glutamic-pyruvic transaminase 谷丙转氨酶
GT Glutamyl transpeptidase 谷氨酰转肽酶
HDLC High-density lipoprotein 高密度脂蛋白
hem Hemoglobin 血红蛋白
LAP Leucine aminopeptidase 亮氨酸氨基肽酶
LDL Low-density lipoprotein 低密度脂蛋白
LF Liver function test 肝功能试验
PhoH Phosphorus 磷
PL Platelet 血小板
pr Protein 蛋白质
SI Serum iron 血清铁
TBA Total bile acid 总胆汁酸
Tca Total calcium 总钙
TP Total protein 总蛋白
trig Triglycerides 甘油三酯
UA Uric acid 尿酸
　 Blood cell;hemocyte 血细胞
　 Erythrocyte sedimentation 血沉；红细胞沉降
七、处方
Aq Aqua 水剂[拉]
Cap Capsule 胶囊
DPI Drug prescription index 药物处方指数
emp Empladstrum 贴膏剂[拉]
INF Infusion 灌注
Inj Injection 注射
IV drop Intravenous drop infusion 静脉滴注
IVP Intravenous push 静脉推注
Lot Lotion 擦剂
Mist Mistura 合剂[拉]
Rx Prescription 处方[拉]
SI Saline infusion 生理盐水灌注
SI Saline injection 生理盐水注射
Sol Solution 溶液
Syr Syrup 糖浆
Tab Tablet 片剂
tr Tincture 酊剂
Ung Unguent 软膏
　 Subcutaneous injection 皮下注射
　 Intramuscular injection 肌内注射
　 External use 外用
八、法律术语
a Action 诉讼
ARB Arbitration 仲裁
c.l. Civil law 民法
cl. Clause 条款
IP Import permit 进口许可证
rec Reclamation 索赔，要求赔偿损失
ref Referee 仲裁人，鉴定人，受委托者
Reg. Regulations 规则，条例
Reg.No. Registered number 注册号，登记的号
repr Representative 代理人，继承人
resp Respond 承担责任
sup Supplement 附加（补充）条款
Sup Ct Supreme court 最高法院
　 Absolute discharge 无条件释放
　 Acquire title to the objects 就标的物取得权利
　 Act of tort 侵权行为
　 Administered prices 控制价格
　 Administrative penalty 行政处罚
　 Administrative regulations 行政法规
　 Alimony 赡养费
　 Body corporate 法人团体
　 Business aggrement 业务协定
　 Circuit of action 巡回诉讼
　 Civil action 民事诉讼
　 Civil legal relations 民事法律关系
　 Civil sanctions 民事制裁
　 Contraband of import 非法进口
　 Contract of sales 销售合同
　 Econmic dispute 经济纠纷
　 Franchise 经销权；特许权
　 Fraud or any other unlawful means 欺骗或其它非法手段
　 Illegal drug 非法药品
　 Instrument of ratification 批准书
　 Interested party 厉害关系人
　 Juristic person 法人
　 Labour protection 劳动保护
　 Legal basis 法律根据
　 Legal provisions 法律规定
　 Legal relation 法律关系
　 Legal system 法制
　 Legislation on labour protection 劳动保护法规
　 Legislature organ 立法机关
　 Licence 许可证；特许证
　 Mediate a dispute 排解纠纷
　 Not to be charged 免予起诉
　 Price control 价格控制
　 Processing of investor's raw materials 来料加工
　 Prosecutor 起诉人
　 Remote damege 间接损害
　 Trade agreement 贸易协定
　 Without obligation 解除责任
九、WTO相关术语
AMS Aggregate Measure of Support 综合支持量
B/L Bill of lading 提单
C.O Certificate of origin 一般原产地证
C/D Customs declaration 报关单
CFR Cost and freight 成本加运费价
CIF Cost,insurance&freight 成本、保险加运费价
CTN/CTNS Carton/cartons 纸箱
D/A Document against acceptance 承兑交单
D/P Document against payment 付款交单
DPV Duty paid value 完税后货物总价；完税后价值
DSB Dispute settlement body 争端解决机构
EMS Express mail special 特快传递
EXP Export 出口
G.S.P. Generalized system of preferences 普惠制
IMP Import 进口
L/C Letter of credit 信用证
MFN Most favored nation 最惠国待遇
OECD Organization for Economic Cooperation and Development 经济合作与发展组织
P/L Packing list 装箱单、明细表
S/C Sales contract 销售确认书
TBT Technical Barrier to Trade 贸易技术壁垒
TRO Tariff-rate Quota 关税配额
URAA Agreement on Agriculture 农业协议
　 Article of General Agreement on Tariffs and Trade 关贸总协定条款
　 Agreement on Import Procedures 进口许可程序协议
　 Agreement on Preshipment Inspection 装运前检验协议
　 Agreement on Safeguards 保障措施协议
　 Agreement on Technical Barriers to
Trade 技术贸易壁垒协议
　 Blue box policies 蓝箱政策
　 Bound tariff rates 约束税率
　 Country schedules 国家减让表
　 Market access 市场准入
　 Non-tariff trade barriers 非关税贸易壁垒
　 Notification process 通知程序
　 Special and differential treatment 特殊差别待遇
　 Tariff 关税
　 Tariffication 关税化

有机物英语单词后缀表
-acetal  缩醇
acid  酸
-al  醛
alcohol  醇
-aldehyde  醛
-aldechydic acid  醛酸
-amarime（或-marine）苦苷
-amic acid  酰胺酸
-amide  酰胺
-amide acid （=amic acid）酰胺酸
-amidine  脒
-amidoxime  脒肟
-amidrazone  脒腙
-amine  胺
-ane  烷
anhydride -ic anhydride
anil  缩苯胺
-anilic acid  酰苯胺酸
-anilide  酰苯胺
-aniside  酰茴香醛
-arsine  胂
-arsinic acid  [美国名指]次胂酸
-arsinous acid  [美国名和英国名均指]卑胂酸
-arsinoxide  胂氧
-arsonic acid  [美国名和英国名均指]胂酸
-arsonous acid  [美国名指]亚胂酸
-ase  酶
-azide  叠氮
-azine  连氮
-betaine  内胺盐
-biarsine  联胂
bi...oyl di..oyl
-bistibine  联锑
bi...yl  联...
-borane  硼烷
-borinic acid 二取代硼酸
-boronic acid  硼酸
-bromohydrin 溴醇
-cacodyl 卡可基
-cain(e) 卡因
-carbamic acid  氨甲酸
-carbazinic acid  肼甲酸
-carbinol  甲醇
-carbodithioic acid  二硫代羧酸
carbohydrazide  N-酰基卡巴肼
-carbohydraoxamamide  甲肟胺
-carbohydroxamic acid  羧肟胺
-carbonamidine  甲脒
-carbonitrile  甲腈
-barbonyl  羰基
-carbothioic acid  羧硫代酸
-carbothiolic acid  甲硫羟酸
-carbothionic acid  甲硫羰酸
-carboxaldehyde  甲醛
-carboxamide  甲酰胺
-carboxamidine 甲脒
-carboxamidoxime  甲胺肟
-carboximidic acid  甲亚胺酸
-carboxylic acid  羧酸
-carbylamine  胩
-cene  并...苯
-chloroarine  氯胂
-chlorohydrin  氯醇
-chrysine  柯因
-cyanamide  氨腈
-cyanhydrin  氰醇
-cyanoarsin  氰胂
-diarsine  联胂
-diazonium  重氮
-dicarboximide  二甲酰亚胺
-dichloroarsine  二氯胂
-diimide  联亚胺
-din(e)  定；啶
di...(o)yl  联…酰
-disulfide  二硫
-dithiocarbamic acid  氨基二硫代羧酸
-di...ylene  联二…亚基
-drin(e)  君[俗名词尾]
-e-  裂[嵌在末一音节之前，指分裂后之产物]
-ene  烯
-ester  酯
ose  糖
-oside 糖苷
-oxide  氧化物
-oxime  肟
-oyl  酰
-oyl halide  酰卤
-ozonide  臭氧
-peroxide  过氧
-phene 芬
-phine  粉；芬 -etane  丁环
-ete  丁
-etene  丁亭[4元无氮一烯环，中文中与-etine不分]
-ether  醚
-etidine  丁啶
-etine  丁亭[4元含氮饱和环]
-florine  花精
-follin  叶素
-folin  叶素
-form  仿
gen  精
-genin  配基
-germanonic acid  基锗酸
-gin  精
-glycol  二醇
-hemiacetal  缩一醇
-hydrazidc  酰肼
-hydrazidine  肼定
-hydrazine  肼
-hydrazone  腙
-hydrin  醇
hydrogen ester  氢酯
hydrosulfamine  巯胺
-hydroxamamide  肟胺
-hydroxamic acid  羟肟酸
-hydroxylamine  胲
-ic anhydride  酸酐
-ic semialdehyde  醛酸
-ide  酰胺
-il 偶酰
-imide  酰亚胺
-imidic acid  亚胺酸
-imine  亚胺
-in  精
-inium -onium
-iodohydrin  碘醇
-irane 丙烷
-irene 丙烯
-iridine  丙啶
-irine  丙因
-isothiourca  异硫脲
-isource  异脲
-ite  糖醇
-itol 糖醇
-ium -onium
-ketal  酮缩醇
-ketene  乙烯酮
-ketazine  酮连氮
-ketimide  酮亚胺
-ketol  乙酮醇
-ketone  酮
-ketoxime  甲酮肟
-lactam  内酰胺
-lactim  内酰亚胺
-lactone  内酯
-lin  灵
-lin(e)  灵
-lysin 溶素
-mercaptal  醛缩硫醇
-mercaptan  硫醇
-mereaptole  酮缩硫醇
-methine  甲碱
-methylene  亚甲基
-min  明
-morpholide  N-酰基吗啉
-naphthalide N-酰基萘胺
-naphthone  酰萘
-nin(e)  宁
-nitramine  硝胺
-nitrile  腈
-nitrolic acid  硝肟酸
-nitrosamine  亚硝胺
-nitrosate  硝酯肟酸
-nitrosolic acid  亚硝肟酸
-nitrosite  亚硝酯肟酸
-oic acid  酸
-oin  偶姻
-ol  醇
-ole  脑，醚
-olic acid  醇酸；脑酸；油酸；炔酸
-olid(e)  交酯
-olidine  烷[5元含氮饱和杂环]
-oline  啉[5元一烯杂环]
-onane  壬环[9元饱和杂环]
-one  酮
-ionic acid 酮酸
-ionic acid 糖酸
-onium  钅翁
-o... one  ...酰...酮
-or  脑
-orthosiliconic acid  原硅酸
-osan  聚糖
-osazone  脎- saccharic acid  糖质酸
saccharinic acid  糖精酸
-sapegenin  皂萆配基
-saponine  皂萆苷
-selenenic acid  次硒酸
-seleninic acid  亚硒酸
-selenol  硒醇
-selenonic acid  硒酸
-semiacetal  醛缩一醇
semialdehyde  -ic semialdehyde
-semicarbazone  缩氨脲
-semicarbazide  氨脲
-semioxamazone  缩半萆肼
-siliconic acid  硅酸
-sin  僧；素
-st-  甾
-stannonic acid  锡酸
-stibine  月弟
-stibinic acid  次锑酸
-stibinous acid  卑锑酸
stibonic acid  锑酸
-stibonium  锑
-stibonous acid  亚锑酸
sulfenamide  次磺酰胺
-sulfenic acid  次磺酸
-sulfide  硫
-sulfilimine  硫亚胺
-sulfinamide  亚磺酰胺
-sulfinic acid  亚磺酸
-sulfonamide  磺酰胺
-sulfone  砜
-sulfonic acid  磺酸
-sulfoxide  亚砜
-sultam  磺内酰胺
-sultone  磺内酯
-tanin  单宁
-tannin 单宁
-tellurinic acid  亚碲酸
-telluronic acid  碲酸
-thetin(e)  噻亭
-thin  质
thioacetal  醛缩硫醇
-thiocarbazone 硫卡巴腙
-pin(e)  品
-pinacol  频哪醇
-pinacolin(e)  频哪酮
-pinacolone  频哪酮
-pinacone -pinacol
-piperidine  N-酰基哌啶
-plumbonic acid  铅酸
-quine  奎
-rin  扔，苷
-rufin  绛酚
-thiohydroxylamine  硫胲
-thioic acid 硫代酸
-thioketene  乙烯硫酮
-thiol  硫醇
-thiolactone  硫代内酯
-thiosemicarbazone  缩胺基硫脲
-thiolic acid  硫羟酸
-thione  硫酮
-thionic acid  硫羰酸
-thionothiolic acid  二硫代羧酸
-thiourea  硫脲
-tin  亭
-toluide  N-酰基甲苯胺
-toxin(e) 毒
-trin  醇
-trisulfide  三硫
-tropin  托品
-ulose  酮糖
-area  脲
-urethan(e)  尿烷
-urethylan(e)  尿基烷
-uric acid  尿酸
-uronic acid  糖醛酸，糖酮酸
-xanthin  黄质
-xanthogenic acid  黄元酸
-xylide  N-酰二甲苯胺
-yl 基
-ylene  亚基
-yl halide  卤代物
-ylidene  亚基
-ylidyne  次基
-ylium  钅翁
-yne  炔
-phenetidide  酰基苯乙定
-phenone  酰苯
-phosphine  膦
-phosphinic acid  次磷酸
-phosphinous acid  卑磷酸
-phosphonic acid  磷酸
-phosphonous acid  亚磷酸
-phyllin(e)  非灵；植素
-picrin  苦碱

lzren · 发表于 2007-7-20 14:47:20

很好的畜牧兽医英语资料

bjliyi · 发表于 2008-4-8 20:47:33

有用

常用药品监管英语与缩略语

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常 用 药 品 监 管 英 语 与 缩 略 语

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常用药品监管英语与缩略语