常用药品监管英语与缩略语


blueski推荐 [2014-1-5]
出处:浙江省药品监督管理局
作者:不详
 

常用药品监管英语与缩略语

监管英语


1.《中华人民共和国药品管理法》 ( 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.)


英文缩写

中 文 翻 译

一、机

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

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

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

(浙江省药品监督管理局政策法规处整理)