食品藥品管理法規(guī)中英文對照在全球化日益加深的今天，食品藥品的安全與質(zhì)量不僅關(guān)乎公眾健康福祉，亦是國際貿(mào)易與經(jīng)濟合作的重要基石。各國均致力于構(gòu)建完善的食品藥品管理法規(guī)體系，以實現(xiàn)有效監(jiān)管、風險防控及權(quán)益保障。本文旨在梳理食品藥品管理領(lǐng)域內(nèi)若干核心法規(guī)概念與要求的中英文對照，為相關(guān)從業(yè)者、研究者及關(guān)注者提供一份實用的參考。一、食品管理法規(guī)核心要點(CorePointsofFoodRegulatoryFramework)食品管理法規(guī)旨在確保食品從生產(chǎn)、加工、儲存、運輸?shù)戒N售的整個鏈條安全可控，適合人類消費，并如實標簽。1.1通用原則與定義(GeneralPrinciplesandDefinitions)*食品安全(FoodSafety)*中文釋義：指食品無毒、無害，符合應(yīng)當有的營養(yǎng)要求，對人體健康不造成任何急性、亞急性或者慢性危害。*EnglishInterpretation:Referstofoodbeingnon-toxicandharmless,meetingtherequirednutritionalstandards,andnotcausinganyacute,subacute,orchronicharmtohumanhealth.*食品生產(chǎn)經(jīng)營者(FoodProducersandOperators)*中文釋義：指從事食品生產(chǎn)、加工、銷售、運輸、儲存等活動的單位和個人。*EnglishInterpretation:Entitiesandindividualsengagedinfoodproduction,processing,distribution,transportation,storage,andotherrelatedactivities.*良好生產(chǎn)規(guī)范(GoodManufacturingPractice-GMP)*中文釋義：是為保障食品安全、質(zhì)量而制定的貫穿食品生產(chǎn)全過程的一系列控制措施、技術(shù)要求和管理規(guī)范。*EnglishInterpretation:Asetofcontrolmeasures,technicalrequirements,andmanagementnorms貫穿theentirefoodproductionprocesstoensurefoodsafetyandquality.1.2具體監(jiān)管要求(SpecificRegulatoryRequirements)*食品標簽(FoodLabeling)*中文要求：食品標簽應(yīng)當標明食品名稱、規(guī)格、凈含量、生產(chǎn)日期、成分或者配料表、生產(chǎn)者的名稱、地址、聯(lián)系方式、保質(zhì)期、產(chǎn)品標準代號、貯存條件、所使用的食品添加劑在國家標準中的通用名稱、生產(chǎn)許可證編號等。*EnglishRequirements:Foodlabelsshallindicatethefoodname,specification,netcontent,productiondate,ingredientslist,nameandaddressoftheproducer,contactinformation,shelflife,productstandardcode,storageconditions,genericnamesoffoodadditivesusedinaccordancewithnationalstandards,productionlicensenumber,etc.*食品召回(FoodRecall)*中文釋義：指食品生產(chǎn)者發(fā)現(xiàn)其生產(chǎn)的食品不符合食品安全標準或者有證據(jù)證明可能危害人體健康的，應(yīng)當立即停止生產(chǎn)，召回已經(jīng)上市銷售的食品，通知相關(guān)生產(chǎn)經(jīng)營者和消費者，并記錄召回和通知情況。*EnglishInterpretation:Whenafoodproducerdiscoversthatthefooditproducesdoesnotmeetfoodsafetystandardsorthereisevidenceprovingitmaybeharmfultohumanhealth,itshallimmediatelystopproduction,recallthefoodthathasbeenputonthemarket,notifyrelevantproducers,operators,andconsumers,andrecordtherecallandnotificationdetails.*食品安全風險評估(FoodSafetyRiskAssessment)*中文釋義：指對食品、食品添加劑、食品相關(guān)產(chǎn)品中的生物性、化學性和物理性危害對人體健康可能造成的不良影響所進行的科學評估。*EnglishInterpretation:Thescientificevaluationofpotentialadverseeffectsonhumanhealthcausedbybiological,chemical,andphysicalhazardsinfood,foodadditives,andfood-relatedproducts.二、藥品管理法規(guī)核心要點(CorePointsofPharmaceuticalRegulatoryFramework)藥品管理法規(guī)聚焦于藥品的研發(fā)、生產(chǎn)、流通、使用等環(huán)節(jié)的質(zhì)量控制、有效性和安全性保障，以及對藥品上市許可持有人、生產(chǎn)企業(yè)、經(jīng)營企業(yè)和醫(yī)療機構(gòu)的監(jiān)管。2.1通用原則與定義(GeneralPrinciplesandDefinitions)*藥品(PharmaceuticalProduct/Drug)*中文釋義：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(yīng)癥或者功能主治、用法和用量的物質(zhì)，包括中藥、化學藥和生物制品等。*EnglishInterpretation:Substancesusedfortheprevention,treatment,ordiagnosisofhumandiseases,purposefullyregulatinghumanphysiologicalfunctions,withspecifiedindications,functions,maintreatments,usage,anddosage,includingtraditionalChinesemedicines,chemicalmedicines,andbiologicalproducts.*藥品上市許可持有人(MarketingAuthorizationHolder-MAH)*中文釋義：指取得藥品注冊證書的企業(yè)或者藥品研制機構(gòu)等。藥品上市許可持有人對藥品的安全性、有效性和質(zhì)量可控性負主體責任。*EnglishInterpretation:Anenterpriseordrugresearchanddevelopmentinstitutionthathasobtainedadrugregistrationcertificate.TheMAHbearsprimaryresponsibilityforthesafety,efficacy,andqualitycontrollabilityofthedrug.*藥品生產(chǎn)質(zhì)量管理規(guī)范(GoodManufacturingPracticeforDrugs-GMP)*中文釋義：是藥品生產(chǎn)和質(zhì)量管理的基本準則，適用于藥品制劑生產(chǎn)的全過程和原料藥生產(chǎn)中影響成品質(zhì)量的關(guān)鍵工序。*EnglishInterpretation:Basicguidelinesforpharmaceuticalproductionandqualitymanagement,applicabletotheentireprocessofpharmaceuticalpreparationproductionandkeyprocessesinactivepharmaceuticalingredient(API)productionthataffectthequalityoffinishedproducts.2.2具體監(jiān)管要求(SpecificRegulatoryRequirements)*藥品注冊(DrugRegistration)*中文釋義：指國家藥品監(jiān)督管理局根據(jù)藥品注冊申請人的申請，依照法定程序，對擬上市銷售藥品的安全性、有效性、質(zhì)量可控性等進行審查，并決定是否同意其申請的審批過程。*EnglishInterpretation:TheapprovalprocesswherebytheNationalMedicalProductsAdministration(NMPA)reviewsthesafety,efficacy,andqualitycontrollabilityofdrugsintendedformarketingbasedonapplicationsfromdrugregistrationapplicants,anddecideswhethertoapprovetheapplicationinaccordancewithlegalprocedures.*藥品不良反應(yīng)(AdverseDrugReaction-ADR)*中文釋義：指合格藥品在正常用法用量下出現(xiàn)的與用藥目的無關(guān)的有害反應(yīng)。*EnglishInterpretation:Harmfulreactionsthatoccurundernormalusageanddosageofqualifieddrugs,whichareunrelatedtotheintendedtherapeuticeffect.*藥品經(jīng)營質(zhì)量管理規(guī)范(GoodSupplyPracticeforDrugs-GSP)*中文釋義：是為加強藥品經(jīng)營質(zhì)量管理，規(guī)范藥品經(jīng)營行為，保障藥品質(zhì)量，根據(jù)《中華人民共和國藥品管理法》等法律、法規(guī)而制定。其核心要求包括對藥品采購、驗收、儲存、養(yǎng)護、銷售、運輸?shù)拳h(huán)節(jié)的管理。*EnglishInterpretation:Formulatedtostrengthenthequalitymanagementofpharmaceuticaldistribution,standardizepharmaceuticaldistributionbehaviors,andensuredrugquality,inaccordancewiththe"DrugAdministrationLawofthePeople'sRepublicofChina"andotherlawsandregulations.Itscorerequirementsincludethemanagementofdrugprocur