经常使用药品监管辞汇中英文.docx
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经常使用药品监管辞汇中英文
1.《中华人民共和国药品治理法》
DrugControlLawofthePeople'sRepublicofChina
2.药品生产企业治理
controloverdrugmanufacturers
3.药品经营企业治理
controloverdrugdistributors
4.医疗机构的药剂治理
controlovermedicinesinmedicalinstitutions
5.药品治理
controloverdrugs
6.药品包装的治理
controloverdrugpackaging
7.药品价钱和广告的治理
controloverdrugpriceandadvertisement
8.药品监督
inspectionofdrugs
9.法律责任
legalliabilities
10.药品标识
labelsormarksofthedrugs
11.假药
counterfeitdrugs
12.劣药
inferiordrugs
13.药品查验机构
drugqualitycontrollaboratory
14.药品的生产企业
drugmanufacturers
15.经营企业
drugdistributors
16.医疗机构
medicalinstitutions
17.药品监督治理部门
drugregulatoryagency
18.药品批准证明文件
drugapprovaldocuments
19.行政处分
administrativesanctions
20.刑事责任
criminalliabilities
21.药品生产质量治理标准
GoodManufacturingPracticeforPharmaceuticalProducts(GMP)
22.药品经营质量治理标准
GoodSupplyPracticeforPharmaceuticalProducts(GSP)
23.药品生产许可证
DrugManufacturingCertificate
24.药品经营许可证
DrugSupplyCertificate
25.医疗机构制剂许可证
PharmaceuticalPreparationCertificateforMedicalInstitution
26.入口药品注册证书
ImportDrugLicense
27.临床实验
clinicaltrial
28.新药证书
NewDrugCertificate
29.药品批准文号
DrugApprovalNumber
30.在中华人民共和国境内从事药品的研制、生产、经营、利用和监督治理的单位或个人,必需遵守《中华人民共和国药品治理法》
Allinstitutionsorindividualsengagedinresearch,production,distribution,use,andadministrationandsupervisionofdrugsinthePeople'sRepublicofChinashallabidebydrugcontrollawofthepeople'srepublicofChina.
31.国务院药品监督治理部门主管全国药品监督治理工作。
ThedrugregulatoryagencyoftheStateCouncilshallberesponsiblefordrugadministrationandsupervisionnationwide.
32.省、自治区、直辖市人民政府药品监督治理部门负责本行政区域内的药品监督治理工作。
Thedrugregulatoryagenciesofthegovernmentsofprovinces,autonomousregions,andmunicipalitiesdirectlyundertheCentralGovernmentshallberesponsiblefordrugregulationintheiradministrativeareas.
33.药品监督治理部门设置或确信的药品查验机构,承担依法实施药品审批和药品质量监督检查所需的药品查验工作。
Thedrugqualitycontrollaboratoriesestablishedordesignatedbydrugregulatoryagenciesshallundertaketheresponsibilityfordrugtestingrequiredforconductingdrugreviewandapprovalandcontrollingdrugqualitypursuanttothelaw.
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治理部门批准并发给《药品生产许可证》,凭《药品生产许可证》到工商行政治理部门办理记录注册。
Anynewlyestablishedpharmaceuticalmanufacturershallbesubjecttoapprovalbythelocaldrugregulatoryagencyofthegovernmentoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernmentandbegrantedtheDrugManufacturingCertificate,and,withthecertificate,themanufacturershallberegisteredwiththeadministrativeagencyforindustryandcommerce.
35.《药品生产许可证》应当标明有效期和生产范围,到期从头审查发证。
ThetermofvalidationandthescopeofmanufacturingshallbenotedintheDrugManufacturingCertificate.Forrenewalofthecertificateonexpiration,reviewingandapprovalagainisrequired.
36.药品监督治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进展计划和产业政策,避免重复建设。
Whengivingapprovaltothenewly-establishedmanufacturer,thedrugregulatoryagencyshallseetoitthatthedevelopmentprogramsandpoliciessetbytheStateforthepharmaceuticalindustryshallbecompliedwithsoastopreventduplicateconstruction.
37.开办药品生产企业,必需具有以下条件:
(一)具有依法通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治理和质量查验的机构、人员和必要的仪器设备;(四)具有保证药品质量的规章制度。
Anydrugmanufacturertobeestablishedshallmeetthefollowingrequirements:
(1)stuffedwithlegallyqualifiedpharmaceuticalandengineeringprofessionalsandthenecessarytechnicalworkers;
(2)providedwiththepremises,facilities,andclearenvironmentrequiredfordrugmanufacturing;(3)havingqualitymanagementandcontrolunitsandpersonnelcapableofqualitymanagementofandtestingfordrugstobeproducedandthenecessaryinstrumentsandequipment;and(4)establishingrulesandregulationstogovernthequalityofdrugs.
38.药品生产企业必需依照国务院药品监督治理部门依据本法制定的《药品生产质量治理标准》组织生产。
药品监督治理部门依照规定对药品生产企业是不是符合《药品生产质量治理标准》的要求进行认证;对认证合格的,发给认证证书。
DrugmanufacturersshallconductproductionaccordingtotheGoodManufacturingPracticeProducts(GMP)formulatedbythedrugregulatoryagencyoftheStateCouncilbasedonthisLaw.ThedrugregulatoryagencyshallinspectadrugmanufacturerastoitscompliancewiththeGMPrequirementsandissueacertificatetothemanufacturerpassingtheinspection.
39.除中药饮片的炮制外,药品必需依照国家药品标准和国务院药品监督治理部门批准的生产工艺进行生产,生产记录必需完整准确。
WiththeexceptionoftheprocessingofpreparedslicesofChinesecrudedrugs,adrugshallbeproducedin
conformitywiththeNationalDrugStandardandwiththeproductionprocessesapprovedbythedrugregulatoryagencyoftheStateCouncil,andtheproductionrecordsshallbecompleteandaccurate.
40.药品生产企业改变阻碍药品质量的生产工艺的,必需报原批准部门审核批准。
Whendrugmanufacturersmakeanychangeintheproductionprocessthatmayaffectthedrugquality,theyshallsubmitthechangetotheoriginalauthorityforreviewingandapproval.
41.生产药品所需的原料、辅料,必需符合药用要求。
Activepharmaceuticalingredients(API)andrecipientsforthemanufactureofpharmaceuticalproductsshallmeettherequirementsformedicinaluse.
42.药品生产企业必需对其生产的药品进行质量查验。
Drugmanufacturersshallperformqualitytestoftheirproducts.
43.不符合国家药品标准或不依照省、自治区、直辖市人民政府药品监督治理部门制定的中药饮片炮制标准炮制的,不得出厂。
NoproductsthatdonotmeettheNationalDrugStandardsorthatarenotproducedaccordingtotheprocessingproceduresforthepreparedslicesofChinesecrudedrugsformulatedbythedrugregulatoryagencyofthegovernmentofaprovince,autonomousregion,ormunicipalitydirectlyundertheCentralGovernmentmaybereleased.
44.经国务院药品监督治理部门或国务院药品监督治理部门授权的省、自治区、直辖市人民政府药品监督治理部门批准,药品生产企业能够同意委托生产药品。
AdrugmanufacturermaynotacceptanycontractproductionofdrugsunlessitisapprovedbythedrugregulatoryagencyoftheStateCouncil,orbythedrugregulatoryagencyofthegovernmentofaprovince,autonomousregion,ormunicipalitydirectlyundertheCentralGovernmentauthorizedbythedrugregulatoryagencyoftheStateCouncil.
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治理部门批准并发给《药品经营许可证》.
Anynewlyestablisheddrugwholesalershallbesubjecttoapprovalofthelocaldrugagencyofthegovernmentoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernmentandbegrantedtheDrugSupplyCertificate.
46.开办药品零售企业,须经企业所在地县级以上地址药品监督治理部门批准并发给《药品经营许可证》。
Anynewlyestablisheddrugretailershallbesubjecttoapprovalandbegrantedtheabovecertificatebythelocaldrug
regulatoryagencyatorabovethecountylevel.
47.药品批发、零售企业凭《药品经营许可证》到工商行政治理部门办理记录注册。
WiththeDrugSupplyCertificate,thewholesalerandtheretailershallberegisteredwiththeadministrativeagencyforindustryandcommerce.
47.无《药品经营许可证》的,不得经营药品。
Nooneispermittedtodistributedrugswithoutthecertificate.
48.《药品经营许可证》应当标明有效期和经营范围,到期从头审查发证。
ThevalidperiodandthescopeofbusinessshallbeindicatedintheDrugSupplyCertificate.Forrenewalofthecertificateuponexpiration,reviewingandapprovalagainisrequired.
49.开办药品经营企业必需具有以下条件:
(一)具有依法通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治理机构或人员;(四)具有保证所经营药品质量的规章制度。
Adrugdistributortobeestablishedshallmeetthefollowingrequirements:
(1)staffedwithlegallyqualifiedpharmaceuticalprofessionals;
(2)providedwiththebusinessoperationpremises,equipment,warehouses,andclearenvironmentrequiredfordrugdistribution;(3)havingthequalitycontrolunitsorpersonneladaptablethedrugstobedistributed;and(4)establishingrulesandregulationstogovernthequalityofthedrugstobedistributed.
50.药品经营企业必需依照国务院药品监督治理部门依据本法制定的《药品经营质量治理标准》经营药品。
DrugdistributorsshallconductbusinessaccordingtotheGoodSupplyPracticeforPharmaceuticalProducts(GSP)setbythedrugregulatoryagencyoftheStateCouncilbasedonthisLaw.
51.药品监督治理部门依照规定对药品经营企业是不是符合《药品经营质量治理标准》的要求进行认证;对认证合格的,发给认证证书。
ThedrugregulatoryagencyinspectadrugdistributorastoitscompliancewiththeGSPrequirements,andissueacertificatetothedistributorpassingtheinspection.
52.药品经营企业购进药品,必需成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。
Afterreceivingthedrugpurchased,drugdistributorsshallpasstheestablishedexaminationandacceptancesystem,andcheckthecertificateofdrugquality,labelsandothersmarks;nodrugsthatfailtomeettherequirementsarepermittedto
bepurchased.
53.药品经营企业购销药品,必需有真实完整的购销记录。
Drugdistributorsshallkeeparealandperfectrecordsofpurchasingandsellingdrugs.
54.购销记录必需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、购销价钱、购(销)货日期及国务院药品监督治理部门规定的其他内容。
Intherecordshallbeindicatedtheadoptednameofdrugs,dosageform,strengthorsize,batchnumber,dateofexpiry,manufacturer,purchaser(orseller),amountofthedrugpurchased(orsold),purchaseorsellingprice,dateofpurchase(orsale),andotheritemsspecifiedbythedrugregulatoryagencyoftheStateCouncil.
55.药品经营企业销售中药材,必需标明产地。
DrugdistributorsshallindicatethehabitatofChinesecrudedrugstobesold.
56.药品经营企业必需制定和执行药品保管制度,采取必要的冷藏、防冻、防潮、防虫、防鼠等方法,保证药品质量。
Adrugdistributorshallpasstheestablishedsystemfordrugstorage,andtakenecessarymeasurestoensuredrugquality,suchascoldstoring,protectingfrombeingfrozenandmoistureandguardingagainstinsectsandrodents.
57.药品入库和出库必需执行检查制度。
Anexaminationsystemshallbefollowedforstoringdrugsinwarehouseandreleasingthemfromwarehouse.
58.城乡集市贸易市场能够出售中药材,国务院还有规定的除外。
Chinesecrudedrugsmaybesoldatfairsinurbanandruralareas,exceptthoseotherwisespecifiedbytheStateCouncil.
59.城乡集市贸易市场不得出售中药材之外的药品,但持有《药品经营许可证》的药品零售企业在规定的范围内能够在城乡集市贸易市场设点出售中药材之外的药品。
NodrugsotherthantheChinesecrudedrugsmaybesoldatfairsinurbanandruralareas,butdrugretailersholdingtheDrugSupplyCertificatemay,withinthespecifiedbusinessscope,sellsuchdrugsatthestorestheys