药用英语

1常用药品监管英语与缩略语——浙江省药品监督管理局政策法规处一、监管英语1.《中华人民共和国药品管理法》DrugControlLawofthePeople'sRepublicofChina2.药品生产企业管理controloverdrugmanufacturers3.药品经营企业管理controloverdrugdistributors4.医疗机构的药剂管理controlovermedicinesinmedicalinstitutions5.药品管理controloverdrugs6.药品包装的管理controloverdrugpackaging7.药品价格和广告的管理controloverdrugpriceandadvertisement8.药品监督inspectionofdrugs9.法律责任legalliabilities10.药品标识labelsormarksofthedrugs11.假药counterfeitdrugs12.劣药inferiordrugs13.药品检验机构drugqualitycontrollaboratory14.药品的生产企业drugmanufacturers15.经营企业drugdistributors16.医疗机构medicalinstitutions17.药品监督管理部门drugregulatoryagency18.药品批准证明文件drugapprovaldocuments19.行政处分administrativesanctions20.刑事责任2criminalliabilities21.药品生产质量管理规范GoodManufacturingPracticeforPharmaceuticalProducts(GMP)22.药品经营质量管理规范GoodSupplyPracticeforPharmaceuticalProducts(GSP)23.药品生产许可证DrugManufacturingCertificate24.药品经营许可证DrugSupplyCertificate25.医疗机构制剂许可证PharmaceuticalPreparationCertificateforMedicalInstitution26.进口药品注册证书ImportDrugLicense27.临床试验clinicaltrial28.新药证书NewDrugCertificate29.药品批准文号DrugApprovalNumber30.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》Allinstitutionsorindividualsengagedinresearch,production,distribution,use,andadministrationandsupervisionofdrugsinthePeople'sRepublicofChinashallabidebydrugcontrollawofthepeople'srepublicofChina.31.国务院药品监督管理部门主管全国药品监督管理工作。ThedrugregulatoryagencyoftheStateCouncilshallberesponsiblefordrugadministrationandsupervisionnationwide.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。Thedrugregulatoryagenciesofthegovernmentsofprovinces,autonomousregions,andmunicipalitiesdirectlyundertheCentralGovernmentshallberesponsiblefordrugregulationintheiradministrativeareas.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。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。Anynewlyestablishedpharmaceuticalmanufacturershallbesubjecttoapprovalbythelocaldrugregulatoryagencyofthegovernmentoftheprovince,3autonomousregionormunicipalitydirectlyundertheCentralGovernmentandbegrantedtheDrugManufacturingCertificate,and,withthecertificate,themanufacturershallberegisteredwiththeadministrativeagencyforindustryandcommerce.35.《药品生产许可证》应当标明有效期和生产范围，到期重新审查发证。ThetermofvalidationandthescopeofmanufacturingshallbenotedintheDrugManufacturingCertificate.Forrenewalofthecertificateonexpiration,reviewingandapprovalagainisrequired.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。Whengivingapprovaltothenewly-establishedmanufacturer,thedrugregulatoryagencyshallseetoitthatthedevelopmentprogramsandpoliciessetbytheStateforthepharmaceuticalindustryshallbecompliedwithsoastopreventduplicateconstruction.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。Anydrugmanufacturertobeestablishedshallmeetthefollowingrequirements:(1)stuffedwithlegallyqualifiedpharmaceuticalandengineeringprofessionalsandthenecessarytechnicalworkers;(2)providedwiththepremises,facilities,andclearenvironmentrequiredfordrugmanufacturing;(3)havingqualitymanagementandcontrolunitsandpersonnelcapableofqualitymanagementofandtestingfordrugstobeproducedandthenecessaryinstrumentsandequipment;and(4)establishingrulesandregulationstogovernthequalityofdrugs.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。DrugmanufacturersshallconductproductionaccordingtotheGoodManufacturingPracticeProducts(GMP)formulatedbythedrugregulatoryagencyoftheStateCouncilbasedonthisLaw.ThedrugregulatoryagencyshallinspectadrugmanufacturerastoitscompliancewiththeGMPrequirementsandissueacertificatetothemanufacturerpassingtheinspection.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。WiththeexceptionoftheprocessingofpreparedslicesofChinesecrudedrugs,adrugshallbeproducedinconformitywiththeNationalDrugStandardandwiththeproductionprocessesapprovedbythedrugregulatoryagencyoftheStateCouncil,andtheproductionrecordsshallbecompleteandaccurate.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4准。Whendrugmanufacturersmakeanychangeintheproductionprocessthatmayaffectthedrugquality,theyshallsubmitthechangetotheoriginalauthorityforreviewingandapproval.41.生产药品所需的原料、辅料，必须符合药用要求。Activepharmaceuticalingredients(API)andrecipientsforthemanufactureofpharmaceuticalproductsshallmeettherequirementsformedicinaluse.42.药品生产企业必须对其生产的药品进行质量检验。Drugmanufacturersshallperformqualitytestoftheirproducts.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。NoproductsthatdonotmeettheNationalDrugStandardsorthatarenotproducedaccordingtotheprocessingproceduresforthepreparedslicesofChinesecrudedrugsformulatedbythedrugregulatoryagencyofthegovernmentofaprovince,autonomousregion,ormunicipalitydirectlyundertheCentralGovernmentmaybereleased.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。Adrugmanufacturerma