常用藥品監(jiān)管詞匯中英文

1、1.《中華人民共和國藥品管理法》DrugControlLawofthePeoplesRepublicofChina2.藥品生產(chǎn)企業(yè)管理controloverdrugmanufacturers3.藥品經(jīng)營企業(yè)管理controloverdrugdistributs4.醫(yī)療機構(gòu)的藥劑管理controlovermedicinesinmedicalinstitutions5.藥品管理controloverdrugs6.藥品包裝的管理control

2、overdrugpackaging7.藥品價格和廣告的管理controloverdrugpriceadvertisement8.藥品監(jiān)督inspectionofdrugs9.法律責(zé)任legalliabilities10.藥品標識labelsmarksofthedrugs11.假藥counterfeitdrugs12.劣藥inferidrugs13.藥品檢驗機構(gòu)drugqualitycontrollabaty14.藥品的生產(chǎn)企業(yè)drugm

3、anufacturers15.經(jīng)營企業(yè)drugdistributs必須遵守《中華人民共和國藥品管理法》AllinstitutionsindividualsengagedinresearchproductiondistributionuseadministrationsupervisionofdrugsinthePeoplesRepublicofChinashallabidebydrugcontrollawofthepeoplesrepu

4、blicofChina.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。ThedrugregulatyagencyoftheStateCouncilshallberesponsiblefdrugadministrationsupervisionnationwide.32.省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門負責(zé)本行政區(qū)域內(nèi)的藥品監(jiān)督管理工作。Thedrugregulatyagenciesofthegovernmentsofp

5、rovincesautonomousregionsmunicipalitiesdirectlyundertheCentralGovernmentshallberesponsiblefdrugregulationintheiradministrativeareas.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。Thedrugqualitycontrollabatiesestab

6、lisheddesignatedbydrugregulatyagenciesshallundertaketheresponsibilityfdrugtestingrequiredfconductingdrugreviewapprovalcontrollingdrugqualitypursuanttothelaw.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

7、證》到工商行政管理部門辦理登記注冊。AnynewlyestablishedpharmaceuticalmanufacturershallbesubjecttoapprovalbythelocaldrugregulatyagencyofthegovernmentoftheprovinceautonomousregionmunicipalitydirectlyundertheCentralGovernmentbegrantedtheDrug

8、ManufacturingCertificatewiththecertificatethemanufacturershallberegisteredwiththeadministrativeagencyfindustrycommerce.35.《藥品生產(chǎn)許可證》應(yīng)當標明有效期和生產(chǎn)范圍，到期重新審查發(fā)證。ThetermofvalidationthescopeofmanufacturingshallbenotedintheDrugManu

9、facturingCertificate.Frenewalofthecertificateonexpirationreviewingapprovalagainisrequired.36.藥品監(jiān)督管理部門批準開辦藥品生產(chǎn)企業(yè)，應(yīng)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(fù)建設(shè)。Whengivingapprovaltothenewlyestablishedmanufacturerthedrugregulatyagencyshalls

10、eetoitthatthedevelopmentprogramspoliciessetbytheStatefthepharmaceuticalindustryshallbecompliedwithsoastopreventduplicateconstruction.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(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