常用藥品監(jiān)管英語與縮略語

（醫(yī)療藥品管理）常用藥

品監(jiān)管英語與縮略語

常用藥品監(jiān)管英語與縮略語

——浙江省藥品監(jiān)督管理局政策法規(guī)處

一、監(jiān)管英語

L《中華人民共和國藥品管理法》

DrugControlLawofthePeople'sRepublicofChina

2.藥品生產(chǎn)企業(yè)管理

controloverdrugmanufacturers

3.藥品經(jīng)營企業(yè)管理

controloverdrugdistributors

4.醫(yī)療機構(gòu)的藥劑管理

controlovermedicinesinmedicalinstitutions

5.藥品管理

controloverdrugs

6.藥品包裝的管理

controloverdrugpackaging

7.藥品價格和廣告的管理

controloverdrugpriceandadvertisement

8.藥品監(jiān)督

inspectionofdrugs

9.法律責(zé)任

legalliabilities

10.藥品標(biāo)識

labelsormarksofthedrugs

11.假藥

counterfeitdrugs

12劣藥

inferiordrugs

13.藥品檢驗機構(gòu)

drugqualitycontrollaboratory

14.藥品的生產(chǎn)企業(yè)

drugmanufacturers

15.經(jīng)營企業(yè)

drugdistributors

16.醫(yī)療機構(gòu)

medicalinstitutions

17.藥品監(jiān)督管理部門

drugregulatoryagency

18.藥品批準(zhǔn)證明文件

drugapprovaldocuments

19彳亍政處分

administrativesanctions

20刑事責(zé)任

criminalliabilities

21.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

DrugManufacturingCertificate

24.藥品經(jīng)營許可證

DrugSupplyCertificate

25.醫(yī)療機構(gòu)制劑許可證

PharmaceuticalPreparationCertificateforMedicalInstitution

26.進(jìn)口藥品注冊證書

ImportDrugLicense

27.臨床試驗

clinicaltrial

28新藥證書

NewDrugCertificate

29.藥品批準(zhǔn)文號

DrugApprovalNumber

30.在中華人民共和國境內(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《中華人民共和國藥品管理法》

Allinstitutionsorindividualsengagedinresearch,production,

distribution,use,andadministrationandsupervisionofdrugsinthe

People'sRepublicofChinashallabidebydrugcontrollawofthe

people'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。

ThedrugregulatoryagencyoftheStateCouncilshallberesponsible

fordrugadministrationandsupervisionnationwide.

32.省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門負(fù)責(zé)本行政區(qū)域內(nèi)的藥

品監(jiān)督管理工作。

Thedrugregulatoryagenciesofthegovernmentsofprovinces,

autonomousregions,andmunicipalitiesdirectlyundertheCentral

Governmentshallberesponsiblefordrugregulationintheir

administrativeareas.

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(dān)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。

Thedrugqualitycontrollaboratoriesestablishedordesignatedby

drugregulatoryagenciesshallundertaketheresponsibilityfordrug

testingrequiredforconductingdrugreviewandapprovaland

controllingdrugqualitypursuanttothelaw.

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(zhǔn)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。

Anynewlyestablishedpharmaceuticalmanufacturershallbesubject

toapprovalbythelocaldrugregulatoryagencyofthegovernmentof

theprovince,autonomousregionormunicipalitydirectlyunderthe

CentralGovernmentandbegrantedtheDrugManufacturing

Certificate,and,withthecertificate,themanufacturershallbe

registeredwiththeadministrativeagencyforindustryandcommerce.

35.《藥品生產(chǎn)許可證》應(yīng)當(dāng)標(biāo)明有效期和生產(chǎn)范圍，到期重新審查發(fā)證。

Thetermofvalidationandthescopeofmanufacturingshallbenoted

intheDrugManufacturingCertificate.Forrenewalofthecertificate

onexpiration,reviewingandapprovalagainisrequired.

36.藥品監(jiān)督管理部門批準(zhǔn)開辦藥品生產(chǎn)企業(yè)，應(yīng)當(dāng)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(fù)建設(shè)。

Whengivingapprovaltothenewly-establishedmanufacturer,the

drugregulatoryagencyshallseetoitthatthedevelopment

programsandpoliciessetbytheStateforthepharmaceutical

industryshallbecompliedwithsoastopreventduplicate

construction.

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(rèn)定

的藥學(xué)技術(shù)人員、工程技術(shù)人員及相應(yīng)的技術(shù)工人；（二）具有與其藥品生

產(chǎn)相適應(yīng)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(jìn)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。

Anydrugmanufacturertobeestablishedshallmeetthefollowing

requirements:（1）stuffedwithlegallyqualifiedpharmaceuticaland

engineeringprofessionalsandthenecessarytechnicalworkers;（2）

providedwiththepremises,facilities,andclearenvironmentrequired

fordrugmanufacturing;（3）havingqualitymanagementandcontrol

unitsandpersonnelcapableofqualitymanagementofandtesting

fordrugstobeproducedandthenecessaryinstrumentsand

equipment;and(4)establishingrulesandregulationstogovernthe

qualityofdrugs.

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(jìn)行認(rèn)證；對認(rèn)證合格的，發(fā)給

認(rèn)證證書。

DrugmanufacturersshallconductproductionaccordingtotheGood

ManufacturingPracticeProducts(GMP)formulatedbythedrug

regulatoryagencyoftheStateCouncilbasedonthisLaw.Thedrug

regulatoryagencyshallinspectadrugmanufacturerastoits

compliancewiththeGMPrequirementsandissueacertificatetothe

manufacturerpassingtheinspection.

39.除中藥飲片的炮制外，藥品必須按照國家藥品標(biāo)準(zhǔn)和國務(wù)院藥品監(jiān)督管

理部門批準(zhǔn)的生產(chǎn)工藝進(jìn)行生產(chǎn)，生產(chǎn)記錄必須完整準(zhǔn)確。

WiththeexceptionoftheprocessingofpreparedslicesofChinese

crudedrugs,adrugshallbeproducedinconformitywiththe

NationalDrugStandardandwiththeproductionprocesses

approvedbythedrugregulatoryagencyoftheStateCouncil,

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(zhǔn)部門審核

批準(zhǔn)。

Whendrugmanufacturersmakeanychangeintheproduction

processthatmayaffectthedrugquality,theyshallsubmitthe

changetotheoriginalauthorityforreviewingandapproval.

41.生產(chǎn)藥品所需的原料、輔料，必須符合藥用要求。

Activepharmaceuticalingredients(API)andrecipientsforthe

manufactureofpharmaceuticalproductsshallmeettherequirements

formedicinaluse.

42.藥品生產(chǎn)企業(yè)必須對其生產(chǎn)的藥品進(jìn)行質(zhì)量檢驗。

Drugmanufacturersshallperformqualitytestoftheirproducts.

43.不符合國家藥品標(biāo)準(zhǔn)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。

NoproductsthatdonotmeettheNationalDrugStandardsorthat

arenotproducedaccordingtotheprocessingproceduresforthe

preparedslicesofChinesecrudedrugsformulatedbythedrug

regulatoryagencyofthegovernmentofaprovince,autonomous

region,ormunicipalitydirectlyundertheCentralGovernmentmaybe

released.

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(zhǔn)，藥品生產(chǎn)企業(yè)可以接受委托

生產(chǎn)藥品。

Adrugmanufacturermaynotacceptanycontractproductionof

drugsunlessitisapprovedbythedrugregulatoryagencyofthe

StateCouncil,orbythedrugregulatoryagencyofthegovernmentof

aprovince,autonomousregion,ormunicipalitydirectlyunderthe

CentralGovernmentauthorizedbythedrugregulatoryagencyofthe

StateCouncil.

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(zhǔn)并發(fā)給《藥品經(jīng)營許可證》.

Anynewlyestablisheddrugwholesalershallbesubjecttoapprovalof

thelocaldrugagencyofthegovernmentoftheprovince,

autonomousregionormunicipalitydirectlyundertheCentral

GovernmentandbegrantedtheDrugSupplyCertificate.

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(zhǔn)并發(fā)給《藥品經(jīng)營許可證》。

Anynewlyestablisheddrugretailershallbesubjecttoapprovaland

begrantedtheabovecertificatebythelocaldrugregulatoryagency

atorabovethecountylevel.

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,thewholesalerandtheretailershall

beregisteredwiththeadministrativeagencyforindustryand

commerce.

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(yīng)當(dāng)標(biāo)明有效期和經(jīng)營范圍，到期重新審查發(fā)證。

Thevalidperiodandthescopeofbusinessshallbeindicatedinthe

DrugSupplyCertificate.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(rèn)定的

藥學(xué)技術(shù)人員；（二）具有與所經(jīng)營藥品相適應(yīng)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(yīng)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。

Adrugdistributortobeestablishedshallmeetthefollowing

requirements:(l)staffedwithlegallyqualifiedpharmaceutical

professionals;(2)providedwiththebusinessoperationpremises,

equipment,warehouses,andclearenvironmentrequiredfordrug

distribution;(3)havingthequalitycontrolunitsorpersonnel

adaptablethedrugstobedistributed;and(4)establishingrulesand

regulationstogovernthequalityofthedrugstobedistributed.

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。

DrugdistributorsshallconductbusinessaccordingtotheGood

SupplyPracticeforPharmaceuticalProducts(GSP)setbythedrug

regulatoryagencyoftheStateCouncilbasedonthisLaw.

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(jìn)行認(rèn)證；對認(rèn)證合格的，發(fā)給認(rèn)證證書。

Thedrugregulatoryagencyinspectadrugdistributorastoits

compliancewiththeGSPrequirements,andissueacertificatetothe

distributorpassingtheinspection.

52.藥品經(jīng)營企業(yè)購進(jìn)藥品，必須建立并執(zhí)行進(jìn)貨檢查驗收制度，驗明藥品

合格證明和其他標(biāo)識；不符合規(guī)定要求的，不得購進(jìn)。

Afterreceivingthedrugpurchased,drugdistributorsshallpassthe

establishedexaminationandacceptancesystem,andcheckthe

certificateofdrugquality,labelsandothersmarks;nodrugsthatfail

tomeettherequirementsarepermittedtobepurchased.

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。

Drugdistributorsshallkeeparealandperfectrecordsofpurchasing

andsellingdrugs.

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,dosage

form,strengthorsize,batchnumber,dateofexpiry,manufacturer,

purchaser(orseller),amountofthedrugpurchased(orsold),

purchaseorsellingprice,dateofpurchase(orsale),andotheritems

specifiedbythedrugregulatoryagencyoftheStateCouncil.

55.藥品經(jīng)營企業(yè)銷售中藥材，必須標(biāo)明產(chǎn)地。

DrugdistributorsshallindicatethehabitatofChinesecrudedrugsto

besold.

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,suchascold

storing,protectingfrombeingfrozenandmoistureandguarding

againstinsectsandrodents.

57.藥品入庫和出庫必須執(zhí)行檢查制度。

Anexaminationsystemshallbefollowedforstoringdrugsin

warehouseandreleasingthemfromwarehouse.

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。

NodrugsotherthantheChinesecrudedrugsmaybesoldatfairsin

urbanandruralareas,butdrugretailersholdingtheDrugSupply

Certificatemay,withinthespecifiedbusinessscope,sellsuchdrugsat

thestorestheysetupatthefairs.

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(zhǔn)，發(fā)

給《醫(yī)療機構(gòu)制劑許可證》。

Dispensingpharmaceuticalpreparationsbyamedicalinstitutionshall

besubjecttoreviewingandpermissionbythehealthadministration

agencyofthegovernmentoftheprovince,autonomousregionor

municipalitydirectlyundertheCentralGovernment,andupon

approvalbythedrugregulatoryagencyofthegovernment.A

PharmaceuticalPreparationCertificateforMedicalInstitutionshallbe

issuedbytheabovedrugregulatoryagency.

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。

Nomedicalinstitutionispermittedtodispensepharmaceutical

preparationswithoutthePharmaceuticalPreparationCertificatefor

MedicalInstitution.

62.《醫(yī)療機構(gòu)制劑許可證》應(yīng)當(dāng)標(biāo)明有效期，到期重新審查發(fā)證。

ThetermofvalidationshallbenotedinthePharmaceutical

PreparationCertificateforMedicalInstitution.Forrenewalofthe

certificateuponexpiration,reviewingandapprovalagainisrequired.

63.醫(yī)療機構(gòu)配制的制劑，應(yīng)當(dāng)是本單位臨床需要而市場上沒有供應(yīng)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(zhǔn)后方可配

制。

Thepharmaceuticalpreparationstobedispensedbythemedical

institutionshallbethosesatisfyingtheclinicneedoftheinstitution

butnotavailableonthemarket.Itshallbesubjecttoapprovalin

advancebythelocaldrugregulatoryagencyofthegovernmentof

theprovince,autonomousregionormunicipalitydirectlyunderthe

CentralGovernment.

64.醫(yī)療機構(gòu)配制的制劑，不得在市場銷售。

Nopharmaceuticalpreparationsdispensedbymedicalinstitutions

arepermittedtobemarketed.

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(biāo)、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(zhǔn)后，方可進(jìn)行臨床試驗。

Afulldescriptionofanewdrugresearchanddevelopmentincluding

themanufacturingprocess,qualityspecifications,resultsof

pharmacologicalandtoxicologicalstudy,andtherelateddataaswell

asthesamplesshall,inaccordancewiththeregulationsofthedrug

regulatoryagencyoftheStateCouncil,betruthfullysubmittedtothe

aboveagencyforreviewingandapproval.

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(zhǔn)，發(fā)

給新藥證書。

Whenanewdrughasgonethroughclinicaltrialsandpassedthe

reviewing,aNewDrugCertificateshallbeissueduponapprovalby

thedrugregulatoryagencyoftheStateCouncil.

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-clinicalsafetyevaluationandstudyandfor

clinicalstudyinstitutionsshallrespectivelyfollowtheGood

LaboratoryPracticeforNon-ClinicalLaboratoryStudies(GLP)and

GoodClinicalPractice(GCP).

68.生產(chǎn)新藥或者已有國家標(biāo)準(zhǔn)的藥品的，須經(jīng)國務(wù)院藥品監(jiān)督管理部門批

準(zhǔn)，并發(fā)給藥品批準(zhǔn)文號"旦是，生產(chǎn)沒有實施批準(zhǔn)文號管理的中藥材和中

藥飲片除外。

Productionofanewdrugorproductionofadrugcomplyingwith

NationalDrugStandardsshallbesubjecttotheapprovalbythedrug

regulatoryagencyoftheStateCouncil,andadrugapprovalnumber

shallbeissuedforit,withtheexceptionoftheChinesecrudedrugs

andthepreparedslicesofChinesecrudedrugsinwhichnocontrol

byapprovalnumberisexercised.

69.實施批準(zhǔn)文號管理的中藥材、中藥飲片品種目錄由國務(wù)院藥品監(jiān)督管理

部門會同國務(wù)院中醫(yī)藥管理部門制定。

ThelistoftheChinesecrudedrugsandthepreparedslicesofthe

Chinesecrudedrugstobecontrolledbytheapprovalnumbershall

becompiledbythedrugregulatoryagencyoftheStateCouncil,

jointlywiththeadministrativeagencyfortraditionalChinese

medicinesoftheStateCouncil.

70.藥品生產(chǎn)企業(yè)在取得藥品批準(zhǔn)文號后，方可生產(chǎn)該藥品。

Adrugmanufacturerispermittedtoproducethedrugonlyafteran

approvalnumberhasbeengrantedtoit.

71.藥品必須符合國家藥品標(biāo)準(zhǔn)。

DrugsshallcomplywiththeNationalDrugStandards.

72.國務(wù)院藥品監(jiān)督管理部門頒布的《中華人民共和國藥典》和藥品標(biāo)準(zhǔn)為

國家藥品標(biāo)準(zhǔn)。

ThePharmacopoeiaofthePeople'sRepublicofChinaandtheDrug

StandardsissuedbythedrugregulatoryagencyoftheStateCouncil

shallserveastheNationalDrugStandards.

73.國務(wù)院藥品監(jiān)督管理部門組織藥典委員會，負(fù)責(zé)國家藥品標(biāo)準(zhǔn)的制定和

修訂。

ThedrugregulatoryagencyoftheStateCouncilshallorganizea

pharmacopoeiacommission,whichshallberesponsiblefor

formulatingandrevisingtheNationalDrugStandards.

74.國務(wù)院藥品監(jiān)督管理部門的藥品檢驗機構(gòu)負(fù)責(zé)標(biāo)定國家藥品標(biāo)準(zhǔn)品、對

照品。

Thedrugcontrolinstitutionaffiliatedtothedrugregulatoryagency

oftheStateCouncilisresponsibleforstandardizingtheNational

DrugStandardSubstanceandReferenceSubstance.

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(jìn)藥品；但是，購進(jìn)沒有實施批準(zhǔn)文號管理的中藥材除外。

Drugmanufacturers,drugdistributorsandmedicalinstitutionsshall

purchasedrugsfrompharmaceuticalenterprises,whicharequalified

forproductionanddistribution,withtheexceptionoftheChinese

crudedrugsinwhichnocontrolbyapprovalnumberisexercised.

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,psychotropic

substances,toxicdrugsformedicaluseandradioactive

pharmaceuticals.

77.國家實行中藥品種保護(hù)制度。

TheStateadoptsaprotectionsystemforcertaintraditionalChinese

medicines.

78.國家對藥品實行處方藥與非處方藥分類管理制度。

TheStateadoptsasystemofclassifiedmanagementforprescription

andnon-prescriptiondrugs.

79.藥品進(jìn)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(rèn)符合質(zhì)

量標(biāo)準(zhǔn)、安全有效的，方可批準(zhǔn)進(jìn)口，并發(fā)給進(jìn)口藥品注冊證書。

Reviewingthedrugstobeimportedshallcomeofthejurisdictionof

thedrugregulatoryagencyoftheStateCouncil.Adrugispermitted

tobeimportedonlyuponapprovalgrantedafterconfirmingthatit

conformstothequality,safelyandefficiencythroughexamination,

andadrugimportationlicenseshallbeissued.

80.國家實行藥品儲備制度。

TheStateadoptsapolicyfordrugstorageforfutureuse.

81.國內(nèi)發(fā)生重大災(zāi)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,epidemicsituationsorotheremergencies

occurinthecountry,thedepartmentdesignatedbytheStateCouncil

mayallocatedrugsfromtheenterprisestomeettheurgentneed.

82.禁止生產(chǎn)（包括配制］銷售假藥。

Production(includingdispensing)anddistributionofcounterfeit

drugsareprohibited.

83有下列情形之一的，為假藥：

Adrugfallingintothefollowingcategoriesisdeemedasa

counterfeitdrug:

（-）藥品所含成份與國家藥品標(biāo)準(zhǔn)規(guī)定的成份不符的；

Theingredientsinthedrugaredifferentfromthosespecifiedbythe

NationalDrugStandards;

（二）以非藥品冒充藥品或者以他種藥品冒充此種藥品的。

Itisnotthesamedrugwhichisclaimedbyitsnameorinrealityitis

notadrugatall.

84有下列情形之一的藥品，按假藥論處:

Adrugfallingintothefollowingcategoriesshallbedeemedasa

counterfeitdrug:

（-）國務(wù)院藥品監(jiān)督管理部門規(guī)定禁止使用的；

It'suseisprohibitedbytheprovisionsofthedrugregulatory

agencyoftheStateCouncil;

（二）依照本法必須批準(zhǔn)而未經(jīng)批準(zhǔn)生產(chǎn)、進(jìn)口，或者依照本法必須檢驗而

未經(jīng)檢驗即銷售的；

Itisproducedorimportedwithoutapproval,ormarketedwithout

beingtested,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(zhǔn)文號而未取得批準(zhǔn)文號的原料藥生產(chǎn)的；

Itisproducedbyusingactivepharmaceuticalingredientswithout

approvalnumberasrequiredbythisLaw;

（六）所標(biāo)明的適應(yīng)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(biāo)準(zhǔn)的，為劣藥。

AdrugwithcontentnotuptotheNationalDrugStandardsisadrug

ofinferiorquality.

87有下列情形之一的藥品，按劣藥論處：

Adrugfallingintothefollowingcategoriesshallbedeemedasa

drugofinferiorquality:

（-）未標(biāo)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(zhǔn)的；

Noapprovalcertificateisobtainedfortheimmediatepackaging

materialorcontainer;

（五）擅自添加著色劑、防腐劑、香料、矯味劑及輔料的；

Colorants,preservatives,spices,flavorings,orotherrecipientshave

beenaddedwithoutauthorization;or

（六）其他不符合藥品標(biāo)準(zhǔn)規(guī)定的。

Othercaseswherethedrugstandardsarenotcompliedwith.

88.列入國家藥品標(biāo)準(zhǔn)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(biāo)使用。

AdrugnamelistedintheNationalDrugStandardsisanadopted

nameinChina.Suchanadoptednameisnotpermittedtobeusedas

atrademark.

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(jìn)行健康檢查。

Staffmembersofdrugmanufacturers,drugdistributorsandmedical

institutionswhomakeadirectcontactwithdrugsshallreceive

physicalexaminationannually.

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。

Thosewhosufferfrominfectiousdiseasesoranyotherdiseasesthat

maycausedrugcontaminationarenotpermittedtoundertakeany

jobindirectcontactwithdrugs.

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(biāo)準(zhǔn)，并由藥品監(jiān)督管理部門在審批藥品時一并審批。

Immediatepackagingmaterialsandcontainersshallmeetthe

requirementsformedicinaluseandcomplywiththestandardsfor

ensuringhumanhealthandsafety.Theyalongwiththedrugsshallbe

subjecttoreviewingandapprovalbythedrugregulatoryagency.

92.藥品包裝必須按照規(guī)定印有或者貼有標(biāo)簽并附有說明書。

Alabelshallbeprintedorstuckonthedrugpackagewithaninsert

sheetattachedasrequiredbyregulations.

93.標(biāo)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(zhǔn)文號、產(chǎn)品批號、生產(chǎn)日期、有效期、適應(yīng)癥或者功能主治、用法、用

量、禁忌、不良反應(yīng)和注意事項。

Inthelabelorinsertsheetshallbeindicatedtheadoptednameof

thedrug,itsingredients,strength,manufacturer,approvalnumber,

productbatchnumber,productiondate,dateofexpiry,indicationsor

functions,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(biāo)簽，必須印有規(guī)定的標(biāo)志。

Specifiedmarksshallbeprintedinthelabelofnarcoticdrugs,

psychotropicsubstances,toxicdrugsformedicaluse,radioactive

pharmaceuticals,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(dǎo)價，

不得以任］可形式擅自提高價格。

Drugmanufacturers,drugdistributorsandmedicalinstitutionsshall

complywiththepricesfixedorguidedbythegovernment.Nooneis

permittedtoraisepricesinanymannerwithoutauthorization.

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,drugdistributorsandmedicalinstitutionsare

prohibitedfromsecretofferingoracceptingrake-offsorother

benefits(notshownintheaccountbook)inthecourseofpurchasing

andsellingdrugs.

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(fù)責(zé)人、藥品采購人員、醫(yī)師等有關(guān)人員以財物或者其他利

Drugmanufacturers,drugdistributorsortheiragentsareprohibited

fromoffering,underanypretence,moneyorgoodsofvalueorother

benefitstoleadingpeople,drugpurchasers,physicians,orother

relatedpersonsofthemedicalinstitutionswheretheirdrugsare

purchased.

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(zhǔn)，并發(fā)給藥品廣告批準(zhǔn)文號；未取得藥品廣告批準(zhǔn)文號的，不得發(fā)布。

Drugadvertisementshallbesubjecttoapprovalbythedrug

regulatoryagenciesofthegovernmentoftheprovince,autonomous

regionormunicipalitydirectlyundertheCentralGovernmentwhere

theenterpriseislocatedandanapprovalnumberofdrug

advertisementshallheissued.Nooneispermittedtorelease

advertisementwithouttheapprovalnumber.

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(xué)、藥學(xué)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(jìn)行以公眾為對象的廣告宣傳。

Prescriptiondrugsmaybeintroducedinthemedicalor

pharmaceuticalprofessionaljournalsjointlydesignatedbythe

administrativeagencyofhealthandthedrugregulatoryagencyof

theStateCouncil,buttheiradvertisementsarenotpermittedtobe

releasedbymassmediaordisseminatedtothegeneralpublicby

othermeans.

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(zhǔn)的說

明書為準(zhǔn)，不得含有虛假的內(nèi)容。

Thecontentofdrugadvertisementshallbetruthfulandlawful,and

shallbebasedontheinsertsheetapprovedbythedrugregulatory

agencyoftheStateCouncil.Thefalsecontentshallnotbecontained

inadvertisement.

10L藥品廣告不得含有不科學(xué)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(xué)術(shù)機構(gòu)或者專家、學(xué)者、醫(yī)師、患者的名義和形象作

證明。

Nounscientificconclusionorguaranteeondrugefficacyispermitted

tobeincludedindrugadvertisement;namesorimagesof

governmentagencies,medicalorpharmaceuticalresearch

institutions,academicinstitutions,orexperts,scholars,physiciansand

patientsareprohibitedfrombeingusedasevidencefordrug

advertising.

102.非藥品廣告不得有涉及藥品的宣傳。

Non-drugadvertisementsnotpermittedtoinvolvewithdrug

promotion.

103.藥品監(jiān)督管理部門進(jìn)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(yīng)當(dāng)保密。

Whenpeoplefromdrugregulatoryagenciesconductsupervisionand

inspection,theyshallshowtheiridentificationdocuments,andshall

keepconfidentialthetechnicalandbusinesssecretsofthepersonsor

theinstitutionsunderinspectionthathavebeeninformedinthe

courseofsupervisionandinspection.

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(jìn)行抽查檢驗。

Drugregulatoryagenciesmayconductselectivetestingofdrug

qualityinlightoftheneedofsupervisionandinspection.

105.抽查檢驗應(yīng)當(dāng)按照規(guī)定抽樣，并不得收取任何費用。

Samplingforselectivetestingshallbecarriedoutaccordingto

relevantregulations,andnofeesarepermittedtobechargedfor

samplingortesting.

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。

Thedrugregulatoryagencyshalltakeadministrativeenforcementto

sealorseizethedrugsandrelatedmaterialsprovedtobepotentially

harmfultohumanhealthandshall.

107.藥品監(jiān)督管理部門應(yīng)當(dāng)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(rèn)證合格的藥品生產(chǎn)企業(yè)、藥品經(jīng)營企業(yè)進(jìn)行

認(rèn)證后的跟蹤檢

Drugregulatoryagenciesshall,inaccordancewithregulationsandon

thebasisoftheGMPandGSP,makethefollow-upinspectiononthe

certifieddrugmanufacturersanddistributors.

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(jìn)入本地區(qū)。

Withregardtothedrugsproducedaccordingtotheprovisionsof

thisLawbydrugmanufacturersnotlocatedintheregion,thelocal

governmentanddrugregulatoryagencyarenotpermittedtorestrict

orrefusetheiraccesstotheregion.

109.國家實行藥品不良反應(yīng)報告制度。

TheStatehasestablishedandexercisedthereportingsystemon

adversedrugreaction(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,DrugSupplyCertificateor

PharmaceuticalPreparationCertificateforMedicalInstitution,the

manufacturerordistributorofdrugormedicalinstitutionshallbe

bannedtoproduceordistributedrugs.

lll.Q)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,thedrugsillegally

producedorsoldandtheillegalincomeshallbeconfiscated,anda

finenotlessthantwotimesbutnotmorethanfivetimesthevalueof

thesaiddrugsshallbecollected.

(2)有藥品批準(zhǔn)證明文件的予以撤銷，并責(zé)令停產(chǎn)、停業(yè)整頓；

Theapprovaldocuments,ifany,shallbewithdrawnandanorder

shallbegiventosuspendproductionorbusinessoperationfor

rectification.

⑶情節(jié)嚴(yán)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)

制并旃可證》；構(gòu)成罪的，依法追究刑事責(zé)任。

Ifthecircumstancesareserious,theDrugManufacturingCertificate,

DrugSupplyCertificateorPharmaceuticalPreparationCertificatefor

MedicalInstitutionshallberevoked.Ifacrimeisconstituted,criminal

liabilitiesshallbeinvestigatedunderthelaw.

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,thedrugsillegally

producedorsoldandtheillegalincomeshallbeconfiscated,anda

finenotlessthanbutnotmorethanthreetimesthevalueofthesaid

drugsshallalsobecollected.

(2)情節(jié)嚴(yán)重的，責(zé)令停產(chǎn)、停業(yè)整頓或者撤銷藥品批準(zhǔn)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,anordershallbegiventosuspend

productionorbusinessoperationforrectification,orthedrug

approvaldocumentsshallbewithdrawnandtheDrugManufacturing

Certificate,theDrugSupplyCertificate,orthePharmaceutical

PreparationCertificateforMedicalInstitutionshallberevoked.

(3)構(gòu)成犯罪的，依法追究刑事責(zé)任。

Ifacrimeisconstituted,criminalliabilitiesshallbeinvestigatedunder

thelaw.

113.藥品，是指用于預(yù)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(yīng)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(xué)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,

treatmentanddiagnosisofhumandiseasesandintendedforthe

regulationofthephysiologicalfunctionsofhumanbeings,with

specificationsofindications,usageanddosage.TheyincludeChinese

crudedrugs,preparedslicesofChinesecrudedrugs,traditional

Chinesemedicines,chemicaldrugsubstances(API)andtheir

preparations,antibiotics,biochemicaldrugs,radioactive

pharmaceuticals,serum,vaccines,bloodproducts,anddiagnostic

agents.

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。

Excipientsrefertothevehiclesandadditivesintendedfor

manufacturingdrugdosageformsandprescriptiondispensing.

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)。

Drugmanufacturersrefertoenterprisesexclusivelyorpartlyengaged

indrugproduction.

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)。

Drugdistributorsrefertoenterprisesexclusivelyorpartlyengagedin

drugdistribution.

117.國務(wù)院藥品監(jiān)督管理部門負(fù)責(zé)全國的醫(yī)療器械監(jiān)督管理工作。

ThedrugregulatoryagencyoftheStateCouncilisresponsiblefor

supervisionanda