藥學(xué)專業(yè)英語

1、精選文檔medicine；drug；remedy藥sleepingpill安息藥contraceptivedrugs避孕藥tonic補(bǔ)藥amedicineforcolds感冒藥expectorant化痰藥anti-cancerdrugs；cancer-fightingdrugs抗癌藥anti-tuberculousdrug抗結(jié)核藥oralcontraceptive；pill口服避孕藥goodmedicine；agoodremedy良藥laxative輕瀉藥antipyretic退熱藥fororaladministration內(nèi)服藥specificmedicine；specific殊效藥fore

2、xternaluse外用藥preventivemedicine；prophylactic預(yù)防藥sedative冷靜藥takemedicine服藥changedressings換藥decoctherbalmedicine煎藥fillaprescription配藥haveaprescriptionmadeup（filled）（患者）抓藥medicinalmaterials；crudedrugs藥材medicinalherbs藥草tablet藥片medicinesandchemicalreagents藥品medicinebottle藥瓶remedies藥石.精選文檔liquidmedicine；me

3、dicinalliquid藥水lotion洗液pill藥丸bolus大藥丸herbalmedicinesinaprescription藥味（中藥方中的藥）flavorofadrug藥味（藥的滋味或氣味）medicines；pharmaceuticals；medicaments藥物healwithdrugs藥物醫(yī)治drugallergy藥物過敏materiamedica藥物學(xué)drugpoisoning藥物中毒medicinal）powder藥粉ointment；salve藥膏applyaplaster上藥膏medicalapparatusandinstruments：醫(yī)療器材pharmaceut

4、icalfactory：藥廠drugstore；chemistsshop；pharmacy：藥店pharmacopeia：藥典prescription：藥方writeoutaprescription：開藥方drugstore；chemistsshop；pharmacy：醫(yī)藥商店hospitalpharmacy；dispensary：醫(yī)院或診所里的藥房expensesformedicine；chargesformedicine：藥費(fèi)apotfordecoctingherbalmedicine：藥罐子chronicinvalid：藥罐子（常常生病的人）apothecariesmeasureorwe

5、ight：藥衡medicinalherbcollector；herbalist：藥農(nóng)herbalmedicineshop：藥鋪.精選文檔asthma哮喘pneumonia肺炎heartdisease心臟病arrhythmia心律不齊indigestion消化不良gastritis胃炎appendicitis盲腸炎hepatitis肝炎dermatitis皮炎freckle/ephelis痣，斑點acne粉刺flu流感diarrhoea痢疾quarantine檢疫vaccinate打疫苗endemic不服水土relapse復(fù)發(fā)癥casualty急癥stupor昏迷sprain扭傷scalding

6、燙傷graze擦傷scratch搔撓trauma外傷bruise淤傷fracture骨折dislocation脫臼tinnitus耳鳴.精選文檔trachoma沙眼colourblindness色盲nearsightedness/myopia近視astigmatism散光gingivitis牙齦炎cavity蛀牙fever發(fā)熱discomfort/disorder不適malnutrition營養(yǎng)不良incubation隱藏期asthenia虛弱poisoning中毒fatigue疲憊heatstroke中暑itching發(fā)癢ache/pain痛tetanus破傷風(fēng)nightsweat盜汗chi

7、ll打冷戰(zhàn)pale神色發(fā)白shuddering發(fā)抖inflammation炎癥acute急癥chronic慢性病congenital先本性病nausea惡心vomit嘔吐.精選文檔常用藥品看守英語與縮略語浙江省藥品督查管理局政策法規(guī)處一、看守英語中華人民共和國藥品管理法DrugControlLawofthePeoplesRepublicofChina藥品生產(chǎn)企業(yè)管理controloverdrugmanufacturers藥品經(jīng)營企業(yè)管理controloverdrugdistributors醫(yī)療機(jī)構(gòu)的藥劑管理controlovermedicinesinmedicalinstitutions藥品管

8、理controloverdrugs藥品包裝的管理.精選文檔controloverdrugpackaging藥品價格和廣告的管理controloverdrugpriceandadvertisement藥品督查inspectionofdrugs法律責(zé)任legalliabilities藥品表記labelsormarksofthedrugs假藥counterfeitdrugs劣藥inferiordrugs.精選文檔藥品檢驗機(jī)構(gòu)drugqualitycontrollaboratory藥品的生產(chǎn)企業(yè)drugmanufacturers經(jīng)營企業(yè)drugdistributors醫(yī)療機(jī)構(gòu)medicalinstit

9、utions藥品督查管理部門drugregulatoryagency藥品贊同證明文件drugapprovaldocuments行政處罰administrativesanctions.精選文檔刑事責(zé)任criminalliabilities藥品生產(chǎn)質(zhì)量管理規(guī)范GoodManufacturingPracticeforPharmaceuticalProducts(GMP)藥品經(jīng)營質(zhì)量管理規(guī)范GoodSupplyPracticeforPharmaceuticalProducts(GSP)藥品生產(chǎn)允許證DrugManufacturingCertificate藥品經(jīng)營允許證DrugSupplyCertifi

10、cate醫(yī)療機(jī)構(gòu)制劑允許證PharmaceuticalPreparationCertificateforMedicalInstitution進(jìn)口藥品注冊證書.精選文檔ImportDrugLicense臨床試驗clinicaltrial新藥證書NewDrugCertificate藥品贊同文號DrugApprovalNumber30.在中華人民共和國境內(nèi)從事藥品的研制、生產(chǎn)、經(jīng)營、使用和督查管理的單位也許個人，一定遵守中華人民共和國藥品管理法Allinstitutionsorindividualsengagedinresearch,production,distribution,use,andad

11、ministrationandsupervisionofdrugsinthePeoplesRepublicofChinashallabidebydrugcontrollawofthepeoplesrepublicofChina.國務(wù)院藥品督查管理部門主管全國藥品督查管理工作。ThedrugregulatoryagencyoftheStateCouncilshallberesponsiblefordrugadministrationandsupervisionnationwide.精選文檔省、自治區(qū)、直轄市人民政府藥品督查管理部門負(fù)責(zé)本行政地區(qū)內(nèi)的藥品督查管理工作。Thedrugregulato

12、ryagenciesofthegovernmentsofprovinces,autonomousregions,andmunicipalitiesdirectlyundertheCentralGovernmentshallberesponsiblefordrugregulationintheiradministrativeareas.藥品督查管理部門設(shè)置也許確立的藥品檢驗機(jī)構(gòu)，擔(dān)當(dāng)依法實行藥品審批和藥質(zhì)量量督查檢查所需的藥品檢驗工作。Thedrugqualitycontrollaboratoriesestablishedordesignatedbydrugregulatoryagenciess

13、hallundertaketheresponsibilityfordrugtestingrequiredforconductingdrugreviewandapprovalandcontrollingdrugqualitypursuanttothelaw.創(chuàng)立藥品生產(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督查管理部門贊同并發(fā)給藥品生產(chǎn)允許證，憑藥品生產(chǎn)允許證到工商行政管理部門辦理登記注冊。Anynewlyestablishedpharmaceuticalmanufacturershallbesubjecttoapprovalbythelocaldrugregulatoryagenc

14、yofthegovernmentoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernmentandbegrantedtheDrugManufacturingCertificate,and,withthecertificate,themanufacturershallberegisteredwiththeadministrativeagencyforindustryandcommerce.精選文檔藥品生產(chǎn)允許證應(yīng)當(dāng)注明有效期和生產(chǎn)范圍，到期重新審察發(fā)證。Thetermofvalidationandthe

15、scopeofmanufacturingshallbenotedintheDrugManufacturingCertificate.Forrenewalofthecertificateonexpiration,reviewingandapprovalagainisrequired.藥品督查管理部門贊同創(chuàng)立藥品生產(chǎn)企業(yè)，應(yīng)當(dāng)切合國家擬訂的藥道德業(yè)發(fā)展規(guī)劃和家產(chǎn)政策，防范重復(fù)建設(shè)。Whengivingapprovaltothenewly-establishedmanufacturer,thedrugregulatoryagencyshallseetoitthatthedevelopmentprog

16、ramsandpoliciessetbytheStateforthepharmaceuticalindustryshallbecompliedwithsoastopreventduplicateconstruction.37.創(chuàng)立藥品生產(chǎn)企業(yè)，一定具備以下條件：（一）擁有依法經(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）擁有與其藥品生產(chǎn)相適應(yīng)的廠房、設(shè)施和衛(wèi)生環(huán)境；（三）擁有能對所生產(chǎn)藥品進(jìn)行質(zhì)量管理和質(zhì)量檢驗的機(jī)構(gòu)、人員以及必需的儀器設(shè)施；（四）擁有保證藥質(zhì)量量的規(guī)章制度。Anydrugmanufacturertobeestablishedshallmeetthefollo

17、wingrequirements:stuffedwithlegallyqualifiedpharmaceuticalandengineeringprofessionalsandthenecessarytechnicalworkers;(2)providedwiththepremises,facilities,andclearenvironmentrequiredfordrugmanufacturing;(3)havingqualitymanagementandcontrolunitsandpersonnelcapableofqualitymanagementofandtestingfordru

18、gstobeproducedandthenecessaryinstrumentsandequipment;and(4)establishingrulesandregulationstogovernthequalityofdrugs.精選文檔藥品生產(chǎn)企業(yè)一定依照國務(wù)院藥品督查管理部門依照本法擬訂的藥品生產(chǎn)質(zhì)量管理規(guī)范組織生產(chǎn)。藥品督查管理部門依照規(guī)定對藥品生產(chǎn)企業(yè)能否切合藥品生產(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。DrugmanufacturersshallconductproductionaccordingtotheGoodManufacturingPracticeProd

19、ucts(GMP)formulatedbythedrugregulatoryagencyoftheStateCouncilbasedonthisLaw.ThedrugregulatoryagencyshallinspectadrugmanufacturerastoitscompliancewiththeGMPrequirementsandissueacertificatetothemanufacturerpassingtheinspection.除中藥飲片的炮制外，藥品一定依照國家藥品標(biāo)準(zhǔn)和國務(wù)院藥品督查管理部門贊同的生產(chǎn)工藝進(jìn)行生產(chǎn)，生產(chǎn)記錄一定完好正確。Withtheexceptionof

20、theprocessingofpreparedslicesofChinesecrudedrugs,adrugshallbeproducedinconformitywiththeNationalDrugStandardandwiththeproductionprocessesapprovedbythedrugregulatoryagencyoftheStateCouncil,andtheproductionrecordsshallbecompleteandaccurate.藥品生產(chǎn)企業(yè)改變影響藥質(zhì)量量的生產(chǎn)工藝的，一定報原贊同部門審察贊同。Whendrugmanufacturersmakeany

21、changeintheproductionprocessthatmayaffectthedrugquality,theyshallsubmitthechangetotheoriginalauthorityforreviewingandapproval.精選文檔生產(chǎn)藥品所需的原料、輔料，一定切合藥用要求。Activepharmaceuticalingredients(API)andrecipientsforthemanufactureofpharmaceuticalproductsshallmeettherequirementsformedicinaluse.藥品生產(chǎn)企業(yè)一定對其生產(chǎn)的藥品進(jìn)行質(zhì)

22、量檢驗。Drugmanufacturersshallperformqualitytestoftheirproducts.不切合國家藥品標(biāo)準(zhǔn)也許不依照省、自治區(qū)、直轄市人民政府藥品督查管理部門擬訂的中藥飲片炮制規(guī)范炮制的，不得出廠。NoproductsthatdonotmeettheNationalDrugStandardsorthatarenotproducedaccordingtotheprocessingproceduresforthepreparedslicesofChinesecrudedrugsformulatedbythedrugregulatoryagencyofthegover

23、nmentofaprovince,autonomousregion,ormunicipalitydirectlyundertheCentralGovernmentmaybereleased.經(jīng)國務(wù)院藥品督查管理部門也許國務(wù)院藥品督查管理部門受權(quán)的省、自治區(qū)、直轄市人民政府藥品督查管理部門贊同，藥品生產(chǎn)企業(yè)可以接受拜托生產(chǎn)藥品。AdrugmanufacturermaynotacceptanycontractproductionofdrugsunlessitisapprovedbythedrugregulatoryagencyoftheStateCouncil,orbythedrugregulat

24、oryagencyofthegovernmentofaprovince,autonomousregion,ormunicip.精選文檔alitydirectlyundertheCentralGovernmentauthorizedbythedrugregulatoryagencyoftheStateCouncil.創(chuàng)立藥品批發(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督查管理部門贊同并發(fā)給藥品經(jīng)營允許證.Anynewlyestablisheddrugwholesalershallbesubjecttoapprovalofthelocaldrugagencyofthegovernment

25、oftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernmentandbegrantedtheDrugSupplyCertificate.創(chuàng)立藥品零售企業(yè)，須經(jīng)企業(yè)所在地縣級以上地方藥品督查管理部門贊同并發(fā)給藥品經(jīng)營允許證。Anynewlyestablisheddrugretailershallbesubjecttoapprovalandbegrantedtheabovecertificatebythelocaldrugregulatoryagencyatorabovethecountylevel.藥品批

26、發(fā)、零售企業(yè)憑藥品經(jīng)營允許證到工商行政管理部門辦理登記注冊。WiththeDrugSupplyCertificate,thewholesalerandtheretailershallberegisteredwiththeadministrativeagencyforindustryandcommerce.無藥品經(jīng)營允許證的，不得經(jīng)營藥品。.精選文檔Nooneispermittedtodistributedrugswithoutthecertificate.藥品經(jīng)營允許證應(yīng)當(dāng)注明有效期和經(jīng)營范圍，到期重新審察發(fā)證。Thevalidperiodandthescopeofbusinessshallb

27、eindicatedintheDrugSupplyCertificate.Forrenewalofthecertificateuponexpiration,reviewingandapprovalagainisrequired.49.創(chuàng)立藥品經(jīng)營企業(yè)一定具備以下條件：（一）擁有依法經(jīng)過資格認(rèn)定的藥學(xué)技術(shù)人員；（二）擁有與所經(jīng)營藥品相適應(yīng)的營業(yè)場所、設(shè)施、倉儲設(shè)施、衛(wèi)生環(huán)境；（三）擁有與所經(jīng)營藥品相適應(yīng)的質(zhì)量管理機(jī)構(gòu)也許人員；（四）擁有保證所經(jīng)營藥質(zhì)量量的規(guī)章制度。Adrugdistributortobeestablishedshallmeetthefollowingrequirements:(

28、1)staffedwithlegallyqualifiedpharmaceuticalprofessionals;(2)providedwiththebusinessoperationpremises,equipment,warehouses,andclearenvironmentrequiredfordrugdistribution;(3)havingthequalitycontrolunitsorpersonneladaptablethedrugstobedistributed;and(4)establishingrulesandregulationstogovernthequalityo

29、fthedrugstobedistributed.藥品經(jīng)營企業(yè)一定依照國務(wù)院藥品督查管理部門依照本法擬訂的藥品經(jīng)營質(zhì)量管理規(guī)范經(jīng)營藥品。DrugdistributorsshallconductbusinessaccordingtotheGoodSupplyPracticeforPharmaceuticalProducts(GSP)setbythedrugregulatoryagencyoftheStateCouncilbasedonthisLaw.精選文檔藥品督查管理部門依照規(guī)定對藥品經(jīng)營企業(yè)能否切合藥品經(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。Thedrugregulato

30、ryagencyinspectadrugdistributorastoitscompliancewiththeGSPrequirements,andissueacertificatetothedistributorpassingtheinspection.藥品經(jīng)營企業(yè)購進(jìn)藥品，一定建立并履行進(jìn)貨檢查查收制度，驗明藥品合格證明和其余表記；不切合規(guī)定要求的，不得購進(jìn)。Afterreceivingthedrugpurchased,drugdistributorsshallpasstheestablishedexaminationandacceptancesystem,andcheckthecerti

31、ficateofdrugquality,labelsandothersmarks;nodrugsthatfailtomeettherequirementsarepermittedtobepurchased.藥品經(jīng)營企業(yè)購銷藥品，一定有真實完好的購銷記錄。Drugdistributorsshallkeeparealandperfectrecordsofpurchasingandsellingdrugs.購銷記錄一定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)目、購銷價格、購（銷）貨日期及國務(wù)院藥品督查管理部門規(guī)定的其余內(nèi)容。.精選文檔Intherecord

32、shallbeindicatedtheadoptednameofdrugs,dosageform,strengthorsize,batchnumber,dateofexpiry,manufacturer,purchaser(orseller),amountofthedrugpurchased(orsold),purchaseorsellingprice,dateofpurchase(orsale),andotheritemsspecifiedbythedrugregulatoryagencyoftheStateCouncil.藥品經(jīng)營企業(yè)銷售中藥材，一定注明產(chǎn)地。Drugdistributor

33、sshallindicatethehabitatofChinesecrudedrugstobesold.藥品經(jīng)營企業(yè)一定擬訂和執(zhí)行藥品保留束度，采納必需的冷藏、防凍、防潮、防蟲、防鼠等措施，保證藥質(zhì)量量。Adrugdistributorshallpasstheestablishedsystemfordrugstorage,andtakenecessarymeasurestoensuredrugquality,suchascoldstoring,protectingfrombeingfrozenandmoistureandguardingagainstinsectsandrodents.藥品入庫

34、和出庫一定執(zhí)行檢查制度。Anexaminationsystemshallbefollowedforstoringdrugsinwarehouseandreleasingthemfromwarehouse.城鄉(xiāng)市集貿(mào)易市場可以銷售中藥材，國務(wù)院還有規(guī)定的除外。.精選文檔Chinesecrudedrugsmaybesoldatfairsinurbanandruralareas,exceptthoseotherwisespecifiedbytheStateCouncil.城鄉(xiāng)市集貿(mào)易市場不得銷售中藥材之外的藥品，但擁有藥品經(jīng)營允許證的藥品零售企業(yè)在規(guī)定的范圍內(nèi)可以在城鄉(xiāng)市集貿(mào)易市場設(shè)點銷售中藥材之外

35、的藥品。NodrugsotherthantheChinesecrudedrugsmaybesoldatfairsinurbanandruralareas,butdrugretailersholdingtheDrugSupplyCertificatemay,withinthespecifiedbusinessscope,sellsuchdrugsatthestorestheysetupatthefairs.醫(yī)療機(jī)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)生行政部門審察贊同，由省、自治區(qū)、直轄市人民政府藥品督查管理部門贊同，發(fā)給醫(yī)療機(jī)構(gòu)制劑允許證。Dispensingpharmaceuti

36、calpreparationsbyamedicalinstitutionshallbesubjecttoreviewingandpermissionbythehealthadministrationagencyofthegovernmentoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernment,anduponapprovalbythedrugregulatoryagencyofthegovernment.APharmaceuticalPreparationCertificateforMedica

37、lInstitutionshallbeissuedbytheabovedrugregulatoryagency.無醫(yī)療機(jī)構(gòu)制劑允許證的醫(yī)療機(jī)構(gòu)，不得配制制劑。NomedicalinstitutionispermittedtodispensepharmaceuticalpreparationswithoutthePharmaceuticalPreparationCertificateforMedicalInstitution.精選文檔醫(yī)療機(jī)構(gòu)制劑允許證應(yīng)當(dāng)注明有效期，到期重新審察發(fā)證。ThetermofvalidationshallbenotedinthePharmaceuticalPrepar

38、ationCertificateforMedicalInstitution.Forrenewalofthecertificateuponexpiration,reviewingandapprovalagainisrequired.醫(yī)療機(jī)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督查管理部門贊同后方可配制。Thepharmaceuticalpreparationstobedispensedbythemedicalinstitutionshallbethosesatisfyingtheclinicneedoftheinstitutionbu

39、tnotavailableonthemarket.Itshallbesubjecttoapprovalinadvancebythelocaldrugregulatoryagencyofthegovernmentoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernment.醫(yī)療機(jī)構(gòu)配制的制劑，不得在市場銷售。Nopharmaceuticalpreparationsdispensedbymedicalinstitutionsarepermittedtobemarketed.研制新藥，一定依照國務(wù)院藥品督查

40、管理部門的規(guī)定照實報送研制方法、質(zhì)量指標(biāo)、藥理及毒理試驗結(jié)果等相關(guān)資料和樣品，經(jīng)國務(wù)院藥品督查管理部門贊同后，方可進(jìn)行臨床試驗。.精選文檔Afulldescriptionofanewdrugresearchanddevelopmentincludingthemanufacturingprocess,qualityspecifications,resultsofpharmacologicalandtoxicologicalstudy,andtherelateddataaswellasthesamplesshall,inaccordancewiththeregulationsofthedrugre

41、gulatoryagencyoftheStateCouncil,betruthfullysubmittedtotheaboveagencyforreviewingandapproval.完成臨床試驗并經(jīng)過審批的新藥，由國務(wù)院藥品督查管理部門贊同，發(fā)給新藥證書。Whenanewdrughasgonethroughclinicaltrialsandpassedthereviewing,aNewDrugCertificateshallbeissueduponapprovalbythedrugregulatoryagencyoftheStateCouncil.藥物的非臨床安全性議論研究機(jī)構(gòu)和臨床試驗機(jī)

42、構(gòu)一定分別執(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).生產(chǎn)新藥也許已有國家標(biāo)準(zhǔn)的藥品的，須經(jīng)國務(wù)院藥品督查管理部門贊同，并發(fā)給藥品贊同文號；但是，生產(chǎn)沒有實行贊同文號管理的中藥材和中藥飲片

43、除外。ProductionofanewdrugorproductionofadrugcomplyingwithNationalDrugStandardsshallbesubjecttotheapprovalbythedrugregulatoryagencyoftheStateCouncil,andadrugapprovalnumbershallbeissuedforit,withtheexce.精選文檔ptionoftheChinesecrudedrugsandthepreparedslicesofChinesecrudedrugsinwhichnocontrolbyapprovalnumbe

44、risexercised.實行贊同文號管理的中藥材、中藥飲片品種目錄由國務(wù)院藥品督查管理部門會同國務(wù)院中醫(yī)藥管理部門擬訂。ThelistoftheChinesecrudedrugsandthepreparedslicesoftheChinesecrudedrugstobecontrolledbytheapprovalnumbershallbecompiledbythedrugregulatoryagencyoftheStateCouncil,jointlywiththeadministrativeagencyfortraditionalChinesemedicinesoftheStateCou

45、ncil.藥品生產(chǎn)企業(yè)在獲得藥品贊同文號后，方可生產(chǎn)該藥品。Adrugmanufacturerispermittedtoproducethedrugonlyafteranapprovalnumberhasbeengrantedtoit.藥品一定切合國家藥品標(biāo)準(zhǔn)。DrugsshallcomplywiththeNationalDrugStandards.國務(wù)院藥品督查管理部門宣告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)。ThePharmacopoeiaofthePeoplesRepublicofChinaandtheDrugStandardsissuedbythedrugregulatorya

46、gencyoftheStateCouncilshallserveastheNationalDrugStandards.精選文檔國務(wù)院藥品督查管理部門組織藥典委員會，負(fù)責(zé)國家藥品標(biāo)準(zhǔn)的擬訂和訂正。ThedrugregulatoryagencyoftheStateCouncilshallorganizeapharmacopoeiacommission,whichshallberesponsibleforformulatingandrevisingtheNationalDrugStandards.國務(wù)院藥品督查管理部門的藥品檢驗機(jī)構(gòu)負(fù)責(zé)標(biāo)定國家藥品標(biāo)準(zhǔn)品、比較品。Thedrugcontrolinst

47、itutionaffiliatedtothedrugregulatoryagencyoftheStateCouncilisresponsibleforstandardizingtheNationalDrugStandardSubstanceandReferenceSubstance.藥品生產(chǎn)企業(yè)、藥品經(jīng)營企業(yè)、醫(yī)療機(jī)構(gòu)一定從擁有藥品生產(chǎn)、經(jīng)營資格的企業(yè)購進(jìn)藥品；但是，購進(jìn)沒有實行贊同文號管理的中藥材除外。Drugmanufacturers,drugdistributorsandmedicalinstitutionsshallpurchasedrugsfrompharmaceuticalente

48、rprises,whicharequalifiedforproductionanddistribution,withtheexceptionoftheChinesecrudedrugsinwhichnocontrolbyapprovalnumberisexercised.國家對麻醉藥品、精神藥品、醫(yī)療用毒性藥品、放射性藥品，實行特別管理。TheStateexercisesspecialcontrolovernarcoticdrugs,psychotropicsubstances,toxicdrugsformedicaluseandradioactivepharmaceuticals.精選文檔國

49、家實行中藥品種保護(hù)制度。TheStateadoptsaprotectionsystemforcertaintraditionalChinesemedicines.國家對藥品實行處方藥與非處方藥分類管理制度。TheStateadoptsasystemofclassifiedmanagementforprescriptionandnon-prescriptiondrugs.藥品進(jìn)口，須經(jīng)國務(wù)院藥品督查管理部門組織審察，經(jīng)審察確認(rèn)切合質(zhì)量標(biāo)準(zhǔn)、安全有效的，方可贊同進(jìn)口，并發(fā)給進(jìn)口藥品注冊證書。Reviewingthedrugstobeimportedshallcomeofthejurisdictio

50、nofthedrugregulatoryagencyoftheStateCouncil.Adrugispermittedtobeimportedonlyuponapprovalgrantedafterconfirmingthatitconformstothequality,safelyandefficiencythroughexamination,andadrugimportationlicenseshallbeissued.國家實行藥品貯備制度。TheStateadoptsapolicyfordrugstorageforfutureuse.81.國內(nèi)發(fā)生重要災(zāi)情、疫情及其余突發(fā)事件時，國務(wù)院

51、規(guī)定的部門可以緊急調(diào)用企業(yè)藥品。.精選文檔Whenmajordisasters,epidemicsituationsorotheremergenciesoccurinthecountry,thedepartmentdesignatedbytheStateCouncilmayallocatedrugsfromtheenterprisestomeettheurgentneed.嚴(yán)禁生產(chǎn)（包含配制）、銷售假藥。Production(includingdispensing)anddistributionofcounterfeitdrugsareprohibited.有以下情況之一的，為假藥：Adrug

52、fallingintothefollowingcategoriesisdeemedasacounterfeitdrug:（一）藥品所含成份與國家藥品標(biāo)準(zhǔn)規(guī)定的成份不符的；TheingredientsinthedrugaredifferentfromthosespecifiedbytheNationalDrugStandards;（二）以非藥品冒充藥品也許以他種藥品冒充此種藥品的。Itisnotthesamedrugwhichisclaimedbyitsnameorinrealityitisnotadrugatall.有以下情況之一的藥品，按假藥論處：Adrugfallingintothefol

53、lowingcategoriesshallbedeemedasacounterfeitdrug:（一）國務(wù)院藥品督查管理部門規(guī)定嚴(yán)禁使用的；.精選文檔ItsuseisprohibitedbytheprovisionsofthedrugregulatoryagencyoftheStateCouncil;（二）依照本法一定贊同而未經(jīng)贊同生產(chǎn)、進(jìn)口，也許依照本法一定檢驗而未經(jīng)檢驗即銷售的；Itisproducedorimportedwithoutapproval,ormarketedwithoutbeingtested,asrequiredbytheLaw;（三）變質(zhì)的；Itisdeteriorat

54、ed;（四）被污染的；Itiscontaminated;（五）使用依照本法一定獲得贊同文號而未獲得贊同文號的原料藥生產(chǎn)的；ItisproducedbyusingactivepharmaceuticalingredientswithoutapprovalnumberasrequiredbythisLaw;（六）所注明的適應(yīng)癥也許功能主治超出規(guī)定范圍的。Theindicationsorfunctionsindicatedarebeyondthespecifiedscope.嚴(yán)禁生產(chǎn)、銷售劣藥。Productionanddistributionofdrugsofinferiorqualityarep

55、rohibited.藥品成份的含量不切合國家藥品標(biāo)準(zhǔn)的，為劣藥。.精選文檔AdrugwithcontentnotuptotheNationalDrugStandardsisadrugofinferiorquality.有以下情況之一的藥品，按劣藥論處：Adrugfallingintothefollowingcategoriesshallbedeemedasadrugofinferiorquality:（一）未注明有效期也許改正有效期的；Thedateofexpiryisnotindicatedorisaltered;（二）不注明也許改正生產(chǎn)批號的；Thebatchnumberisnotindi

56、catedorisaltered;（三）超出有效期的；Itisbeyondthedateofexpiry;（四）直接接觸藥品的包裝資料和容器未經(jīng)贊同的；Noapprovalcertificateisobtainedfortheimmediatepackagingmaterialorcontainer;（五）擅自增加著色劑、防腐劑、香料、矯味劑及輔料的；Colorants,preservatives,spices,flavorings,orotherrecipientshavebeenaddedwithoutauthorization;or（六）其余不切合藥品標(biāo)準(zhǔn)規(guī)定的。Othercaseswh

57、erethedrugstandardsarenotcompliedwith.精選文檔列入國家藥品標(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。AdrugnamelistedintheNationalDrugStandardsisanadoptednameinChina.Suchanadoptednameisnotpermittedtobeusedasatrademark.藥品生產(chǎn)企業(yè)、藥品經(jīng)營企業(yè)和醫(yī)療機(jī)構(gòu)直接接觸藥品的工作人員，一定每年進(jìn)行健康檢查。Staffmembersofdrugmanufacturers,drugdistributorsandmed

58、icalinstitutionswhomakeadirectcontactwithdrugsshallreceivephysicalexaminationannually.患有傳得病也許其余可能污染藥品的疾病的，不得從事直接接觸藥品的工作。Thosewhosufferfrominfectiousdiseasesoranyotherdiseasesthatmaycausedrugcontaminationarenotpermittedtoundertakeanyjobindirectcontactwithdrugs.直接接觸藥品的包裝資料和容器，一定切合藥用要求，切合保障人體健康、安全的標(biāo)準(zhǔn)，并

59、由藥品督查管理部門在審批藥品時一并審批。Immediatepackagingmaterialsandcontainersshallmeettherequirementsformedicinaluseandcomplywiththestandardsforensuringhumanhealthandsafety.精選文檔Theyalongwiththedrugsshallbesubjecttoreviewingandapprovalbythedrugregulatoryagency.藥品包裝一定依照規(guī)定印有也許貼有標(biāo)簽并附有說明書。Alabelshallbeprintedorstuckonthe

60、drugpackagewithaninsertsheetattachedasrequiredbyregulations.標(biāo)簽也許說明書上一定注明藥品的通用名稱、成份、規(guī)格、生產(chǎn)企業(yè)、贊同文號、產(chǎn)品批號、生產(chǎn)日期、有效期、適應(yīng)癥也許功能主治、用法、用量、禁忌、不良反響和注意事項。Inthelabelorinsertsheetshallbeindicatedtheadoptednameofthedrug,itsingredients,strength,manufacturer,approvalnumber,productbatchnumber,productiondate,dateofexpiry