常用藥品監(jiān)管詞匯中英文

..1.《中華人民XX國藥品管理法》DrugControlLawofthePeople'sRepublicofChina2.藥品生產(chǎn)企業(yè)管理controloverdrugmanufacturers3.藥品經(jīng)營企業(yè)管理controloverdrugdistributors4.醫(yī)療機構(gòu)的藥劑管理controlovermedicinesinmedicalinstitutions5.藥品管理controloverdrugs6.藥品包裝的管理controloverdrugpackaging7.藥品價格和廣告的管理controloverdrugpriceandadvertisement8.藥品監(jiān)督inspectionofdrugs9.法律責任legalliabilities10.藥品標識labelsormarksofthedrugs11.假藥counterfeitdrugs12.劣藥inferiordrugs13.藥品檢驗機構(gòu)drugqualitycontrollaboratory14.藥品的生產(chǎn)企業(yè)drugmanufacturers15.經(jīng)營企業(yè)drugdistributors16.醫(yī)療機構(gòu)medicalinstitutions17.藥品監(jiān)督管理部門drugregulatoryagency18.藥品批準證明文件drugapprovaldocuments19.行政處分administrativesanctions20.刑事責任criminalliabilities21.藥品生產(chǎn)質(zhì)量管理規(guī)范GoodManufacturingPracticeforPharmaceuticalProducts<GMP>22.藥品經(jīng)營質(zhì)量管理規(guī)范GoodSupplyPracticeforPharmaceuticalProducts<GSP>23.藥品生產(chǎn)許可證DrugManufacturingCertificate24.藥品經(jīng)營許可證DrugSupplyCertificate25.醫(yī)療機構(gòu)制劑許可證PharmaceuticalPreparationCertificateforMedicalInstitution26.進口藥品注冊證書ImportDrugLicense27.臨床試驗clinicaltrial28.新藥證書NewDrugCertificate29.藥品批準文號DrugApprovalNumber30.在中華人民XX國境內(nèi)從事藥品的研制、生產(chǎn)、經(jīng)營、使用和監(jiān)督管理的單位或者個人,必須遵守《中華人民XX國藥品管理法》Allinstitutionsorindividualsengagedinresearch,production,distribution,use,andadministrationandsupervisionofdrugsinthePeople'sRepublicofChinashallabidebydrugcontrollawofthepeople'srepublicofChina.31.國務(wù)院藥品監(jiān)督管理部門主管全國藥品監(jiān)督管理工作。ThedrugregulatoryagencyoftheStateCouncilshallberesponsiblefordrugadministrationandsupervisionnationwide.32.省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門負責本行政區(qū)域內(nèi)的藥品監(jiān)督管理工作。Thedrugregulatoryagenciesofthegovernmentsofprovinces,autonomousregions,andmunicipalitiesdirectlyundertheCentralGovernmentshallberesponsiblefordrugregulationintheiradministrativeareas.33.藥品監(jiān)督管理部門設(shè)置或者確定的藥品檢驗機構(gòu),承擔依法實施藥品審批和藥品質(zhì)量監(jiān)督檢查所需的藥品檢驗工作。Thedrugqualitycontrollaboratoriesestablishedordesignatedbydrugregulatoryagenciesshallundertaketheresponsibilityfordrugtestingrequiredforconductingdrugreviewandapprovalandcontrollingdrugqualitypursuanttothelaw.34.開辦藥品生產(chǎn)企業(yè),須經(jīng)企業(yè)所在地省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準并發(fā)給《藥品生產(chǎn)許可證》,憑《藥品生產(chǎn)許可證》到工商行政管理部門辦理登記注冊。Anynewlyestablishedpharmaceuticalmanufacturershallbesubjecttoapprovalbythelocaldrugregulatoryagencyofthegovernmentoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernmentandbegrantedtheDrugManufacturingCertificate,and,withthecertificate,themanufacturershallberegisteredwiththeadministrativeagencyforindustryandcommerce.35.《藥品生產(chǎn)許可證》應當標明有效期和生產(chǎn)范圍,到期重新審查發(fā)證。ThetermofvalidationandthescopeofmanufacturingshallbenotedintheDrugManufacturingCertificate.Forrenewalofthecertificateonexpiration,reviewingandapprovalagainisrequired.36.藥品監(jiān)督管理部門批準開辦藥品生產(chǎn)企業(yè),應當符合國家制定的藥品行業(yè)發(fā)展規(guī)劃和產(chǎn)業(yè)政策,防止重復建設(shè)。Whengivingapprovaltothenewly-establishedmanufacturer,thedrugregulatoryagencyshallseetoitthatthedevelopmentprogramsandpoliciessetbytheStateforthepharmaceuticalindustryshallbecompliedwithsoastopreventduplicateconstruction.37.開辦藥品生產(chǎn)企業(yè),必須具備以下條件：〔一具有依法經(jīng)過資格認定的藥學技術(shù)人員、工程技術(shù)人員及相應的技術(shù)工人；〔二具有與其藥品生產(chǎn)相適應的廠房、設(shè)施和衛(wèi)生環(huán)境；〔三具有能對所生產(chǎn)藥品進行質(zhì)量管理和質(zhì)量檢驗的機構(gòu)、人員以及必要的儀器設(shè)備；〔四具有保證藥品質(zhì)量的規(guī)章制度。Anydrugmanufacturertobeestablishedshallmeetthefollowingrequirements:<1>stuffedwithlegallyqualifiedpharmaceuticalandengineeringprofessionalsandthenecessarytechnicalworkers;<2>providedwiththepremises,facilities,andclearenvironmentrequiredfordrugmanufacturing;<3>havingqualitymanagementandcontrolunitsandpersonnelcapableofqualitymanagementofandtestingfordrugstobeproducedandthenecessaryinstrumentsandequipment;and<4>establishingrulesandregulationstogovernthequalityofdrugs.38.藥品生產(chǎn)企業(yè)必須按照國務(wù)院藥品監(jiān)督管理部門依據(jù)本法制定的《藥品生產(chǎn)質(zhì)量管理規(guī)范》組織生產(chǎn)。藥品監(jiān)督管理部門按照規(guī)定對藥品生產(chǎn)企業(yè)是否符合《藥品生產(chǎn)質(zhì)量管理規(guī)范》的要求進行認證；對認證合格的,發(fā)給認證證書。DrugmanufacturersshallconductproductionaccordingtotheGoodManufacturingPracticeProducts<GMP>formulatedbythedrugregulatoryagencyoftheStateCouncilbasedonthisLaw.ThedrugregulatoryagencyshallinspectadrugmanufacturerastoitscompliancewiththeGMPrequirementsandissueacertificatetothemanufacturerpassingtheinspection.39.除中藥飲片的炮制外,藥品必須按照國家藥品標準和國務(wù)院藥品監(jiān)督管理部門批準的生產(chǎn)工藝進行生產(chǎn),生產(chǎn)記錄必須完整準確。WiththeexceptionoftheprocessingofpreparedslicesofChinesecrudedrugs,adrugshallbeproducedinconformitywiththeNationalDrugStandardandwiththeproductionprocessesapprovedbythedrugregulatoryagencyoftheStateCouncil,andtheproductionrecordsshallbecompleteandaccurate.40.藥品生產(chǎn)企業(yè)改變影響藥品質(zhì)量的生產(chǎn)工藝的,必須報原批準部門審核批準。Whendrugmanufacturersmakeanychangeintheproductionprocessthatmayaffectthedrugquality,theyshallsubmitthechangetotheoriginalauthorityforreviewingandapproval.41.生產(chǎn)藥品所需的原料、輔料,必須符合藥用要求。Activepharmaceuticalingredients<API>andrecipientsforthemanufactureofpharmaceuticalproductsshallmeettherequirementsformedicinaluse.42.藥品生產(chǎn)企業(yè)必須對其生產(chǎn)的藥品進行質(zhì)量檢驗。Drugmanufacturersshallperformqualitytestoftheirproducts.43.不符合國家藥品標準或者不按照省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門制定的中藥飲片炮制規(guī)范炮制的,不得出廠。NoproductsthatdonotmeettheNationalDrugStandardsorthatarenotproducedaccordingtotheprocessingproceduresforthepreparedslicesofChinesecrudedrugsformulatedbythedrugregulatoryagencyofthegovernmentofaprovince,autonomousregion,ormunicipalitydirectlyundertheCentralGovernmentmaybereleased.44.經(jīng)國務(wù)院藥品監(jiān)督管理部門或者國務(wù)院藥品監(jiān)督管理部門授權(quán)的省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準,藥品生產(chǎn)企業(yè)可以接受委托生產(chǎn)藥品。AdrugmanufacturermaynotacceptanycontractproductionofdrugsunlessitisapprovedbythedrugregulatoryagencyoftheStateCouncil,orbythedrugregulatoryagencyofthegovernmentofaprovince,autonomousregion,ormunicipalitydirectlyundertheCentralGovernmentauthorizedbythedrugregulatoryagencyoftheStateCouncil.45.開辦藥品批發(fā)企業(yè),須經(jīng)企業(yè)所在地省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準并發(fā)給《藥品經(jīng)營許可證》.Anynewlyestablisheddrugwholesalershallbesubjecttoapprovalofthelocaldrugagencyofthegovernmentoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernmentandbegrantedtheDrugSupplyCertificate.46.開辦藥品零售企業(yè),須經(jīng)企業(yè)所在地縣級以上地方藥品監(jiān)督管理部門批準并發(fā)給《藥品經(jīng)營許可證》。Anynewlyestablisheddrugretailershallbesubjecttoapprovalandbegrantedtheabovecertificatebythelocaldrugregulatoryagencyatorabovethecountylevel.47.藥品批發(fā)、零售企業(yè)憑《藥品經(jīng)營許可證》到工商行政管理部門辦理登記注冊。WiththeDrugSupplyCertificate,thewholesalerandtheretailershallberegisteredwiththeadministrativeagencyforindustryandcommerce.47.無《藥品經(jīng)營許可證》的,不得經(jīng)營藥品。Nooneispermittedtodistributedrugswithoutthecertificate.48.《藥品經(jīng)營許可證》應當標明有效期和經(jīng)營范圍,到期重新審查發(fā)證。ThevalidperiodandthescopeofbusinessshallbeindicatedintheDrugSupplyCertificate.Forrenewalofthecertificateuponexpiration,reviewingandapprovalagainisrequired.49.開辦藥品經(jīng)營企業(yè)必須具備以下條件：〔一具有依法經(jīng)過資格認定的藥學技術(shù)人員；〔二具有與所經(jīng)營藥品相適應的營業(yè)場所、設(shè)備、倉儲設(shè)施、衛(wèi)生環(huán)境；〔三具有與所經(jīng)營藥品相適應的質(zhì)量管理機構(gòu)或者人員；〔四具有保證所經(jīng)營藥品質(zhì)量的規(guī)章制度。Adrugdistributortobeestablishedshallmeetthefollowingrequirements:<1>staffedwithlegallyqualifiedpharmaceuticalprofessionals;<2>providedwiththebusinessoperationpremises,equipment,warehouses,andclearenvironmentrequiredfordrugdistribution;<3>havingthequalitycontrolunitsorpersonneladaptablethedrugstobedistributed;and<4>establishingrulesandregulationstogovernthequalityofthedrugstobedistributed.50.藥品經(jīng)營企業(yè)必須按照國務(wù)院藥品監(jiān)督管理部門依據(jù)本法制定的《藥品經(jīng)營質(zhì)量管理規(guī)范》經(jīng)營藥品。DrugdistributorsshallconductbusinessaccordingtotheGoodSupplyPracticeforPharmaceuticalProducts<GSP>setbythedrugregulatoryagencyoftheStateCouncilbasedonthisLaw.51.藥品監(jiān)督管理部門按照規(guī)定對藥品經(jīng)營企業(yè)是否符合《藥品經(jīng)營質(zhì)量管理規(guī)范》的要求進行認證；對認證合格的,發(fā)給認證證書。ThedrugregulatoryagencyinspectadrugdistributorastoitscompliancewiththeGSPrequirements,andissueacertificatetothedistributorpassingtheinspection.52.藥品經(jīng)營企業(yè)購進藥品,必須建立并執(zhí)行進貨檢查驗收制度,驗明藥品合格證明和其他標識；不符合規(guī)定要求的,不得購進。Afterreceivingthedrugpurchased,drugdistributorsshallpasstheestablishedexaminationandacceptancesystem,andcheckthecertificateofdrugquality,labelsandothersmarks;nodrugsthatfailtomeettherequirementsarepermittedtobepurchased.53.藥品經(jīng)營企業(yè)購銷藥品,必須有真實完整的購銷記錄。Drugdistributorsshallkeeparealandperfectrecordsofpurchasingandsellingdrugs.54.購銷記錄必須注明藥品的通用名稱、劑型、規(guī)格、批號、有效期、生產(chǎn)廠商、購〔銷貨單位、購〔銷貨數(shù)量、購銷價格、購〔銷貨日期及國務(wù)院藥品監(jiān)督管理部門規(guī)定的其他內(nèi)容。Intherecordshallbeindicatedtheadoptednameofdrugs,dosageform,strengthorsize,batchnumber,dateofexpiry,manufacturer,purchaser<orseller>,amountofthedrugpurchased<orsold>,purchaseorsellingprice,dateofpurchase<orsale>,andotheritemsspecifiedbythedrugregulatoryagencyoftheStateCouncil.55.藥品經(jīng)營企業(yè)銷售中藥材,必須標明產(chǎn)地。DrugdistributorsshallindicatethehabitatofChinesecrudedrugstobesold.56.藥品經(jīng)營企業(yè)必須制定和執(zhí)行藥品保管制度,采取必要的冷藏、防凍、防潮、防蟲、防鼠等措施,保證藥品質(zhì)量。Adrugdistributorshallpasstheestablishedsystemfordrugstorage,andtakenecessarymeasurestoensuredrugquality,suchascoldstoring,protectingfrombeingfrozenandmoistureandguardingagainstinsectsandrodents.57.藥品入庫和出庫必須執(zhí)行檢查制度。Anexaminationsystemshallbefollowedforstoringdrugsinwarehouseandreleasingthemfromwarehouse.58.城鄉(xiāng)集市貿(mào)易市場可以出售中藥材,國務(wù)院另有規(guī)定的除外。Chinesecrudedrugsmaybesoldatfairsinurbanandruralareas,exceptthoseotherwisespecifiedbytheStateCouncil.59.城鄉(xiāng)集市貿(mào)易市場不得出售中藥材以外的藥品,但持有《藥品經(jīng)營許可證》的藥品零售企業(yè)在規(guī)定的范圍內(nèi)可以在城鄉(xiāng)集市貿(mào)易市場設(shè)點出售中藥材以外的藥品。NodrugsotherthantheChinesecrudedrugsmaybesoldatfairsinurbanandruralareas,butdrugretailersholdingtheDrugSupplyCertificatemay,withinthespecifiedbusinessscope,sellsuchdrugsatthestorestheysetupatthefairs.60.醫(yī)療機構(gòu)配制制劑,須經(jīng)所在地省、自治區(qū)、直轄市人民政府衛(wèi)生行政部門審核同意,由省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準,發(fā)給《醫(yī)療機構(gòu)制劑許可證》。Dispensingpharmaceuticalpreparationsbyamedicalinstitutionshallbesubjecttoreviewingandpermissionbythehealthadministrationagencyofthegovernmentoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernment,anduponapprovalbythedrugregulatoryagencyofthegovernment.APharmaceuticalPreparationCertificateforMedicalInstitutionshallbeissuedbytheabovedrugregulatoryagency.61.無《醫(yī)療機構(gòu)制劑許可證》的醫(yī)療機構(gòu),不得配制制劑。NomedicalinstitutionispermittedtodispensepharmaceuticalpreparationswithoutthePharmaceuticalPreparationCertificateforMedicalInstitution.62.《醫(yī)療機構(gòu)制劑許可證》應當標明有效期,到期重新審查發(fā)證。ThetermofvalidationshallbenotedinthePharmaceuticalPreparationCertificateforMedicalInstitution.Forrenewalofthecertificateuponexpiration,reviewingandapprovalagainisrequired.63.醫(yī)療機構(gòu)配制的制劑,應當是本單位臨床需要而市場上沒有供應的品種,并須經(jīng)所在地省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準后方可配制。Thepharmaceuticalpreparationstobedispensedbythemedicalinstitutionshallbethosesatisfyingtheclinicneedoftheinstitutionbutnotavailableonthemarket.Itshallbesubjecttoapprovalinadvancebythelocaldrugregulatoryagencyofthegovernmentoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernment.64.醫(yī)療機構(gòu)配制的制劑,不得在市場銷售。Nopharmaceuticalpreparationsdispensedbymedicalinstitutionsarepermittedtobemarketed.65.研制新藥,必須按照國務(wù)院藥品監(jiān)督管理部門的規(guī)定如實報送研制方法、質(zhì)量指標、藥理及毒理試驗結(jié)果等有關(guān)資料和樣品,經(jīng)國務(wù)院藥品監(jiān)督管理部門批準后,方可進行臨床試驗。Afulldescriptionofanewdrugresearchanddevelopmentincludingthemanufacturingprocess,qualityspecifications,resultsofpharmacologicalandtoxicologicalstudy,andtherelateddataaswellasthesamplesshall,inaccordancewiththeregulationsofthedrugregulatoryagencyoftheStateCouncil,betruthfullysubmittedtotheaboveagencyforreviewingandapproval.66.完成臨床試驗并通過審批的新藥,由國務(wù)院藥品監(jiān)督管理部門批準,發(fā)給新藥證書。Whenanewdrughasgonethroughclinicaltrialsandpassedthereviewing,aNewDrugCertificateshallbeissueduponapprovalbythedrugregulatoryagencyoftheStateCouncil.67.藥物的非臨床安全性評價研究機構(gòu)和臨床試驗機構(gòu)必須分別執(zhí)行藥物非臨床研究質(zhì)量管理規(guī)范、藥物臨床試驗質(zhì)量管理規(guī)范。Theinstitutionsfornon-clinicalsafetyevaluationandstudyandforclinicalstudyinstitutionsshallrespectivelyfollowtheGoodLaboratoryPracticeforNon-ClinicalLaboratoryStudies<GLP>andGoodClinicalPractice<GCP>.70.藥品生產(chǎn)企業(yè)在取得藥品批準文號后,方可生產(chǎn)該藥品。Adrugmanufacturerispermittedtoproducethedrugonlyafteranapprovalnumberhasbeengrantedtoit.71.藥品必須符合國家藥品標準。DrugsshallcomplywiththeNationalDrugStandards.72.國務(wù)院藥品監(jiān)督管理部門頒布的《中華人民XX國藥典》和藥品標準為國家藥品標準。ThePharmacopoeiaofthePeople'sRepublicofChinaandtheDrugStandardsissuedbythedrugregulatoryagencyoftheStateCouncilshallserveastheNationalDrugStandards.73.國務(wù)院藥品監(jiān)督管理部門組織藥典委員會,負責國家藥品標準的制定和修訂。ThedrugregulatoryagencyoftheStateCouncilshallorganizeapharmacopoeiacommission,whichshallberesponsibleforformulatingandrevisingtheNationalDrugStandards.74.國務(wù)院藥品監(jiān)督管理部門的藥品檢驗機構(gòu)負責標定國家藥品標準品、對照品。ThedrugcontrolinstitutionaffiliatedtothedrugregulatoryagencyoftheStateCouncilisresponsibleforstandardizingtheNationalDrugStandardSubstanceandReferenceSubstance.75.藥品生產(chǎn)企業(yè)、藥品經(jīng)營企業(yè)、醫(yī)療機構(gòu)必須從具有藥品生產(chǎn)、經(jīng)營資格的企業(yè)購進藥品；但是,購進沒有實施批準文號管理的中藥材除外。Drugmanufacturers,drugdistributorsandmedicalinstitutionsshallpurchasedrugsfrompharmaceuticalenterprises,whicharequalifiedforproductionanddistribution,withtheexceptionoftheChinesecrudedrugsinwhichnocontrolbyapprovalnumberisexercised.76.國家對麻醉藥品、精神藥品、醫(yī)療用毒性藥品、放射性藥品,實行特殊管理。TheStateexercisesspecialcontrolovernarcoticdrugs,psychotropicsubstances,toxicdrugsformedicaluseandradioactivepharmaceuticals.77.國家實行中藥品種保護制度。TheStateadoptsaprotectionsystemforcertaintraditionalChinesemedicines.78.國家對藥品實行處方藥與非處方藥分類管理制度。TheStateadoptsasystemofclassifiedmanagementforprescriptionandnon-prescriptiondrugs.79.藥品進口,須經(jīng)國務(wù)院藥品監(jiān)督管理部門組織審查,經(jīng)審查確認符合質(zhì)量標準、安全有效的,方可批準進口,并發(fā)給進口藥品注冊證書。ReviewingthedrugstobeimportedshallcomeofthejurisdictionofthedrugregulatoryagencyoftheStateCouncil.Adrugispermittedtobeimportedonlyuponapprovalgrantedafterconfirmingthatitconformstothequality,safelyandefficiencythroughexamination,andadrugimportationlicenseshallbeissued.80.國家實行藥品儲備制度。TheStateadoptsapolicyfordrugstorageforfutureuse.81.國內(nèi)發(fā)生重大災情、疫情及其他突發(fā)事件時,國務(wù)院規(guī)定的部門可以緊急調(diào)用企業(yè)藥品。Whenmajordisasters,epidemicsituationsorotheremergenciesoccurinthecountry,thedepartmentdesignatedbytheStateCouncilmayallocatedrugsfromtheenterprisestomeettheurgentneed.82.禁止生產(chǎn)〔包括配制、銷售假藥。Production<includingdispensing>anddistributionofcounterfeitdrugsareprohibited.83.有下列情形之一的,為假藥：Adrugfallingintothefollowingcategoriesisdeemedasacounterfeitdrug:〔一藥品所含成份與國家藥品標準規(guī)定的成份不符的；TheingredientsinthedrugaredifferentfromthosespecifiedbytheNationalDrugStandards;〔二以非藥品冒充藥品或者以他種藥品冒充此種藥品的。Itisnotthesamedrugwhichisclaimedbyitsnameorinrealityitisnotadrugatall.84.有下列情形之一的藥品,按假藥論處：Adrugfallingintothefollowingcategoriesshallbedeemedasacounterfeitdrug:〔一國務(wù)院藥品監(jiān)督管理部門規(guī)定禁止使用的；It’suseisprohibitedbytheprovisionsofthedrugregulatoryagencyoftheStateCouncil;〔二依照本法必須批準而未經(jīng)批準生產(chǎn)、進口,或者依照本法必須檢驗而未經(jīng)檢驗即銷售的；Itisproducedorimportedwithoutapproval,ormarketedwithoutbeingtested,asrequiredbytheLaw;〔三變質(zhì)的；Itisdeteriorated;〔四被污染的；Itiscontaminated;〔五使用依照本法必須取得批準文號而未取得批準文號的原料藥生產(chǎn)的；ItisproducedbyusingactivepharmaceuticalingredientswithoutapprovalnumberasrequiredbythisLaw;〔六所標明的適應癥或者功能主治超出規(guī)定范圍的。Theindicationsorfunctionsindicatedarebeyondthespecifiedscope.85.禁止生產(chǎn)、銷售劣藥。Productionanddistributionofdrugsofinferiorqualityareprohibited.86.藥品成份的含量不符合國家藥品標準的,為劣藥。AdrugwithcontentnotuptotheNationalDrugStandardsisadrugofinferiorquality.87.有下列情形之一的藥品,按劣藥論處：Adrugfallingintothefollowingcategoriesshallbedeemedasadrugofinferiorquality:〔一未標明有效期或者更改有效期的；Thedateofexpiryisnotindicatedorisaltered;〔二不注明或者更改生產(chǎn)批號的；Thebatchnumberisnotindicatedorisaltered;〔三超過有效期的；Itisbeyondthedateofexpiry;〔四直接接觸藥品的包裝材料和容器未經(jīng)批準的；Noapprovalcertificateisobtainedfortheimmediatepackagingmaterialorcontainer;〔五擅自添加著色劑、防腐劑、香料、矯味劑及輔料的；Colorants,preservatives,spices,flavorings,orotherrecipientshavebeenaddedwithoutauthorization;or〔六其他不符合藥品標準規(guī)定的。Othercaseswherethedrugstandardsarenotcompliedwith.88.列入國家藥品標準的藥品名稱為藥品通用名稱。已經(jīng)作為藥品通用名稱的,該名稱不得作為藥品商標使用。AdrugnamelistedintheNationalDrugStandardsisanadoptednameinChina.Suchanadoptednameisnotpermittedtobeusedasatrademark.89.藥品生產(chǎn)企業(yè)、藥品經(jīng)營企業(yè)和醫(yī)療機構(gòu)直接接觸藥品的工作人員,必須每年進行健康檢查。Staffmembersofdrugmanufacturers,drugdistributorsandmedicalinstitutionswhomakeadirectcontactwithdrugsshallreceivephysicalexaminationannually.90.患有傳染病或者其他可能污染藥品的疾病的,不得從事直接接觸藥品的工作。Thosewhosufferfrominfectiousdiseasesoranyotherdiseasesthatmaycausedrugcontaminationarenotpermittedtoundertakeanyjobindirectcontactwithdrugs.91.直接接觸藥品的包裝材料和容器,必須符合藥用要求,符合保障人體健康、安全的標準,并由藥品監(jiān)督管理部門在審批藥品時一并審批。Immediatepackagingmaterialsandcontainersshallmeettherequirementsformedicinaluseandcomplywiththestandardsforensuringhumanhealthandsafety.Theyalongwiththedrugsshallbesubjecttoreviewingandapprovalbythedrugregulatoryagency.92.藥品包裝必須按照規(guī)定印有或者貼有標簽并附有說明書。Alabelshallbeprintedorstuckonthedrugpackagewithaninsertsheetattachedasrequiredbyregulations.93.標簽或者說明書上必須注明藥品的通用名稱、成份、規(guī)格、生產(chǎn)企業(yè)、批準文號、產(chǎn)品批號、生產(chǎn)日期、有效期、適應癥或者功能主治、用法、用量、禁忌、不良反應和注意事項。Inthelabelorinsertsheetshallbeindicatedtheadoptednameofthedrug,itsingredients,strength,manufacturer,approvalnumber,productbatchnumber,productiondate,dateofexpiry,indicationsorfunctions,usage,dosage,contraindications,drugadversereactions,andprecautions.94.麻醉藥品、精神藥品、醫(yī)療用毒性藥品、放射性藥品、外用藥品和非處方藥的標簽,必須印有規(guī)定的標志。Specifiedmarksshallbeprintedinthelabelofnarcoticdrugs,psychotropicsubstances,toxicdrugsformedicaluse,radioactivepharmaceuticals,drugsfortopicaluse,andnon-prescriptiondrugs.95.藥品的生產(chǎn)企業(yè)、經(jīng)營企業(yè)和醫(yī)療機構(gòu)必須執(zhí)行政府定價、政府指導價,不得以任何形式擅自提高價格。Drugmanufacturers,drugdistributorsandmedicalinstitutionsshallcomplywiththepricesfixedorguidedbythegovernment.Nooneispermittedtoraisepricesinanymannerwithoutauthorization.96.禁止藥品的生產(chǎn)企業(yè)、經(jīng)營企業(yè)和醫(yī)療機構(gòu)在藥品購銷中帳外暗中給予、收受回扣或者其他利益。Drugmanufacturers,drugdistributorsandmedicalinstitutionsareprohibitedfromsecretofferingoracceptingrake-offsorotherbenefits<notshownintheaccountbook>inthecourseofpurchasingandsellingdrugs.97.禁止藥品的生產(chǎn)企業(yè)、經(jīng)營企業(yè)或者其代理人以任何名義給予使用其藥品的醫(yī)療機構(gòu)的負責人、藥品采購人員、醫(yī)師等有關(guān)人員以財物或者其他利益。Drugmanufacturers,drugdistributorsortheiragentsareprohibitedfromoffering,underanypretence,moneyorgoodsofvalueorotherbenefitstoleadingpeople,drugpurchasers,physicians,orotherrelatedpersonsofthemedicalinstitutionswheretheirdrugsarepurchased.98.藥品廣告須經(jīng)企業(yè)所在地省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準,并發(fā)給藥品廣告批準文號；未取得藥品廣告批準文號的,不得發(fā)布。Drugadvertisementshallbesubjecttoapprovalbythedrugregulatoryagenciesofthegovernmentoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernmentwheretheenterpriseislocatedandanapprovalnumberofdrugadvertisementshallheissued.Nooneispermittedtoreleaseadvertisementwithouttheapprovalnumber.99.處方藥可以在國務(wù)院衛(wèi)生行政部門和國務(wù)院藥品監(jiān)督管理部門共同指定的醫(yī)學、藥學專業(yè)刊物上介紹,但不得在大眾傳播媒介發(fā)布廣告或者以其他方式進行以公眾為對象的廣告宣傳。PrescriptiondrugsmaybeintroducedinthemedicalorpharmaceuticalprofessionaljournalsjointlydesignatedbytheadministrativeagencyofhealthandthedrugregulatoryagencyoftheStateCouncil,buttheiradvertisementsarenotpermittedtobereleasedbymassmediaordisseminatedtothegeneralpublicbyothermeans.100.藥品廣告的內(nèi)容必須真實、合法,以國務(wù)院藥品監(jiān)督管理部門批準的說明書為準,不得含有虛假的內(nèi)容。Thecontentofdrugadvertisementshallbetruthfulandlawful,andshallbebasedontheinsertsheetapprovedbythedrugregulatoryagencyoftheStateCouncil.Thefalsecontentshallnotbecontainedinadvertisement.101.藥品廣告不得含有不科學的表示功效的斷言或者保證；不得利用國家機關(guān)、醫(yī)藥科研單位、學術(shù)機構(gòu)或者專家、學者、醫(yī)師、患者的名義和形象作證明。Nounscientificconclusionorguaranteeondrugefficacyispermittedtobeincludedindrugadvertisement;namesorimagesofgovernmentagencies,medicalorpharmaceuticalresearchinstitutions,academicinstitutions,orexperts,scholars,physiciansandpatientsareprohibitedfrombeingusedasevidencefordrugadvertising.102.非藥品廣告不得有涉及藥品的宣傳。Non-drugadvertisementsnotpermittedtoinvolvewithdrugpromotion.103.藥品監(jiān)督管理部門進行監(jiān)督檢查時,必須出示證明文件,對監(jiān)督檢查中知悉的被檢查人的技術(shù)秘密和業(yè)務(wù)秘密應當保密。Whenpeoplefromdrugregulatoryagenciesconductsupervisionandinspection,theyshallshowtheiridentificationdocuments,andshallkeepconfidentialthetechnicalandbusinesssecretsofthepersonsortheinstitutionsunderinspectionthathavebeeninformedinthecourseofsupervisionandinspection.104.藥品監(jiān)督管理部門根據(jù)監(jiān)督檢查的需要,可以對藥品質(zhì)量進行抽查檢驗。Drugregulatoryagenciesmayconductselectivetestingofdrugqualityinlightoftheneedofsupervisionandinspection.105.抽查檢驗應當按照規(guī)定抽樣,并不得收取任何費用。Samplingforselectivetestingshallbecarriedoutaccordingtorelevantregulations,andnofeesarepermittedtobechargedforsamplingortesting.106.藥品監(jiān)督管理部門對有證據(jù)證明可能危害人體健康的藥品及其有關(guān)材料可以采取查封、扣押的行政強制措施。Thedrugregulatoryagencyshalltakeadministrativeenforcementtosealorseizethedrugsandrelatedmaterialsprovedtobepotentiallyharmfultohumanhealthandshall.107.藥品監(jiān)督管理部門應當按照規(guī)定,依據(jù)《藥品生產(chǎn)質(zhì)量管理規(guī)范》、《藥品經(jīng)營質(zhì)量管理規(guī)范》,對經(jīng)其認證合格的藥品生產(chǎn)企業(yè)、藥品經(jīng)營企業(yè)進行認證后的跟蹤檢查。Drugregulatoryagenciesshall,inaccordancewithregulationsandonthebasisoftheGMPandGSP,makethefollow-upinspectiononthecertifieddrugmanufacturersanddistributors.108.地方人民政府和藥品監(jiān)督管理部門不得以要求實施藥品檢驗、審批等手段限制或者排斥非本地區(qū)藥品生產(chǎn)企業(yè)依照本法規(guī)定生產(chǎn)的藥品進入本地區(qū)。WithregardtothedrugsproducedaccordingtotheprovisionsofthisLawbydrugmanufacturersnotlocatedintheregion,thelocalgovernmentanddrugregulatoryagencyarenotpermittedtorestrictorrefusetheiraccesstotheregion.109.國家實行藥品不良反應報告制度。TheStatehasestablishedandexercisedthereportingsystemonadversedrugreaction<ADR>.110.未取得《藥品生產(chǎn)許可證》、《藥品經(jīng)營許可證》或者《醫(yī)療機構(gòu)制劑許可證》生產(chǎn)藥品、經(jīng)營藥品的,依法予以取締WithoutDrugManufacturingCertificate,DrugSupplyCertificateorPharmaceuticalPreparationCertificateforMedicalInstitution,themanufacturerordistributorofdrugormedicalinstitutionshallbebannedtoproduceordistributedrugs.111.<1>生產(chǎn)、銷售假藥的,沒收違法生產(chǎn)、銷售的藥品和違法所得,并處違法生產(chǎn)、銷售藥品貨值金額二倍以上五倍以下的罰款；Wherecounterfeitdrugsareproducedorsold,thedrugsillegallyproducedorsoldandtheillegalincomeshallbeconfiscated,andafinenotlessthantwotimesbutnotmorethanfivetimesthevalueofthesaiddrugsshallbecollected.<2>有藥品批準證明文件的予以撤銷,并責令停產(chǎn)、停業(yè)整頓；Theapprovaldocuments,ifany,shallbewithdrawnandanordershallbegiventosuspendproductionorbusinessoperationforrectification.<3>情節(jié)嚴重的,吊銷《藥品生產(chǎn)許可證》、《藥品經(jīng)營許可證》或者《醫(yī)療機構(gòu)制劑許可證》；構(gòu)成犯罪的,依法追究刑事責任。Ifthecircumstancesareserious,theDrugManufacturingCertificate,DrugSupplyCertificateorPharmaceuticalPreparationCertificateforMedicalInstitutionshallberevoked.Ifacrimeisconstituted,criminalliabilitiesshallbeinvestigatedunderthelaw.112.<1>生產(chǎn)、銷售劣藥的,沒收違法生產(chǎn)、銷售的藥品和違法所得,并處違法生產(chǎn)、銷售藥品貨值金額一倍以上三倍以下的罰款；Whereinferiordrugsareproducedorsold,thedrugsillegallyproducedorsoldandtheillegalincomeshallbeconfiscated,andafinenotlessthanbutnotmorethanthreetimesthevalueofthesaiddrugsshallalsobecollected.<2>情節(jié)嚴重的,責令停產(chǎn)、停業(yè)整頓或者撤銷藥品批準證明文件、吊銷《藥品生產(chǎn)許可證》、《藥品經(jīng)營許可證》或者《醫(yī)療機構(gòu)制劑許可證》；Ifthecircumstancesareserious,anordershallbegiventosuspendproductionorbusinessoperationforrectification,orthedrugapprovaldocumentsshallbewithdrawnandtheDrugManufacturingCertificate,theDrugSupplyCertificate,orthePharmaceuticalPreparationCertificateforMedicalInstitutionshallberevoked.<3>構(gòu)成犯罪的,依法追究刑事責任。Ifacrimeisconstituted,criminalliabilitiesshallbeinvestigatedunderthelaw.113.藥品,是指用于預防、治療、診斷人的疾病,有目的地調(diào)節(jié)人的生理機能并規(guī)定有適應癥或者功能主治、用法和用量的物質(zhì),包括中藥材、中藥飲片、中成藥、化學原料藥及其制劑、抗生素、生化藥品、放射性藥品、血清、疫苗、血液制品和診斷藥品等。Drugsrefertotheproductsthatareusedintheprevention,treatmentanddiagnosisofhumandiseasesandintendedfortheregulationofthephysiologicalfunctionsofhumanbeings,withspecificationsofindications,usageanddosage.TheyincludeChinesecrudedrugs,preparedslicesofChinesecrudedrugs,traditionalChinesemedicines,chemicaldrugsubstances<API>andtheirpreparations,antibiotics,biochemicaldrugs,radioactivepharmaceuticals,serum,vaccines,bloodproducts,anddiagnosticagents.114.輔料,是指生產(chǎn)藥品和調(diào)配處方時所用的賦形劑和附加劑。Excipientsrefertothevehiclesandadditivesintendedformanufacturingdrugdosageformsandprescriptiondispensing.115.藥品生產(chǎn)企業(yè),是指生產(chǎn)藥品的專營企業(yè)或者兼營企業(yè)。Drugmanufacturersrefertoenterprisesexclusivelyorpartlyengagedindrugproduction.116.藥品經(jīng)營企業(yè),是指經(jīng)營藥品的專營企業(yè)或者兼營企業(yè)。Drugdistributorsrefertoenterprisesexclusivelyorpartlyengagedindrugdistribution.117.國務(wù)院藥品監(jiān)督管理部門負責全國的醫(yī)療器械監(jiān)督管理工作。ThedrugregulatoryagencyoftheStateCouncilisresponsibleforsupervisionandadministrationofmedicaldevicesnationwide.118.國家對醫(yī)療器械實行分類管理。TheStateshallcarryoutthepolicyofclassificationadministrationofmedicaldevices.119.國家對醫(yī)療器械實行產(chǎn)品生產(chǎn)注冊制度。TheStateshallimplementaproductregistrationsystemformanufacturingmedicaldevices.120.生產(chǎn)第一類醫(yī)療器械,由設(shè)區(qū)的市級人民政府藥品監(jiān)督管理部門審查批準,并發(fā)給產(chǎn)品生產(chǎn)注冊證書。ClassImedicaldevicesshallbeinspected,approvedandissuedaregistrationcertificatebythedrugregulatoryagencyofthegovernmentofthemunicipalitieswithdistricts.121.生產(chǎn)第二類醫(yī)療器械,由省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門審查批準,并發(fā)給產(chǎn)品生產(chǎn)注冊證書。ClassⅡmedicaldevicesshallbeinspected,approvedandissuedregistrationcertificatesbythedrugregulatoryagencyofprovinces,autonomousregionsandmunicipalitiesdirectlyoftheCentralGovernment.122.生產(chǎn)第三類醫(yī)療器械,由國務(wù)院藥品監(jiān)督管理部門審查批準,并發(fā)給產(chǎn)品生產(chǎn)注冊證書。生產(chǎn)第二類、第三類醫(yī)療器械,應當通過臨床驗證。ClassⅢmedicaldevicesshallbeinspected,approvedandissuedregistrationcertificatesbythedrugregulatoryagencydirectlyundertheStateCouncil.123.醫(yī)療器械產(chǎn)品注冊證書有效期四年。Thetermofvalidityfortheregistrationcertificateofmedicaldevicesisfouryears.124.生產(chǎn)醫(yī)療器械,應當符合醫(yī)療器械國家標準；沒有國家標準的,應當符合醫(yī)療器械行業(yè)標準。Medicaldevicesmanufacturedshallmeetthenationalstandard,orprofessionalstandardswhentherearenorelevantnationalstandardsavailable.125.醫(yī)療器械的使用說明書、標簽、包裝應當符合國家有關(guān)標準或者規(guī)定。Theinstructionforuse,labelandpackageofmedicaldevicesshallcomplywithrelevantstandardsorprovisionsinChina.126.醫(yī)療器械及其外包裝上應當按照國務(wù)院藥品監(jiān)督管理部門的規(guī)定,標明產(chǎn)品注冊證書編號。TheregistrationnumberofamedicaldeviceshallbemarkedontheproductitselfandontheexternalpackageaccordingtotheprovisionsofthedrugregulatoryagencyoftheStateCouncil.127.開辦第一類醫(yī)療器械生產(chǎn)企業(yè),應當向省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門備案。ForthemanufacturingofclassImedicaldevices,itrequiresthattheenterprisefilearecordwiththedrugregulatoryagencyofprovinc