摘要药品作为一种特殊的商品，既有治病救人的功能，也有致病害人的潜在风险。近些年，我国药品安全事故频发，给我国公民的健康和生命带来了越来越大的威胁，我们不得不对药品安全监管进行反思。本文第一部分概述了政策工具的内涵、分类等相关概念；第二部分对当前我国的药品安全监管的现状和问题进行了剖析，着重指出了这些的问题：一是药品安全监管存在监管力度不足。二是药品市场主体责任意识不强。三是公众对药品安全认知不足；第三部分对日本在药品监管方面的优秀经验和做法作了概述，并提出了几点启示，例如完善的法律法规体系、上市后监管系统、独立行政公法人机构等政策工具运用等；作为文章的重点，第四部分从强制性工具、自愿性工具、混合性工具这三类政策治理工具方面论述了我国药品安全监管的政策工具选择：从强制性政策工具方面提出政府要加强药品安全的监管并且完善政府购买服务；从混合性政策工具方面提出了创新药品批准文号申请与转让管理，政府补贴及税收减免激励医药企业发展；从自愿性政策工具方面提出利用市场监管强化企业自律建设，发挥医药行业协会协助作用。总之，通过形成多元工具协同监管，逐步实现我国药品安全长效监管机制。关键词药品安全；政策工具；多元监管DrugsafetysupervisioninChinafromtheperspectiveofpolicytoolsAuthor:WuSujieTutor:ZhaoZhanjunLecturerAbstractAsaspecialcommodity,medicinehasboththefunctionofsavingthediseaseandthepotentialrisksofthedisease.Inrecentyears,thefrequentoccurrenceofdrugsafetyaccidentsinChinahasbroughtmoreandmorethreatstothehealthandlifeofourcitizens,andwehavetorethinkthedrugsafetysupervision.Thefirstpartofthispaperoutlinestheconnotation,classificationandotherrelatedconceptsofpolicytools;thesecondpartanalysesthecurrentsituationandproblemsofdrugsafetysupervisioninChina,andpointsouttheseproblems.First,thereisinsufficientsupervisionindrugsafetysupervision.Second,theresponsibilityconsciousnessofthemainbodyofthedrugmarketisnotstrong.Threeisthelackofpublicawarenessofdrugsafety;ThethirdpartgivesanoverviewoftheexcellentexperienceandpracticeofJapanesedrugregulation,andputsforwardsomesuggestions,suchastheperfectlegalsystem,thepostmarketsupervisionsystem,theapplicationofthepolicytools,suchastheindependentadministrativepubliclaw,andsoon.Asthekeypointofthearticle,thefourthpartdiscussesthechoiceofthepolicytoolsofChina'sdrugsafetysupervisionfromthethreekindsofpolicytools:compulsorytools,voluntarytoolsandmixedtools.Fromtheperspectiveofcompulsorypolicytools,thegovernmentshouldstrengthendrugsafetysupervisionandimprovegovernmentprocurementservices.Fromtheperspectiveofmixedpolicytools,theapplicationandtransfermanagementofinnovativedrugapprovalnumberisproposed,andthedevelopmentofpharmaceuticalenterprisesisencouragedbygovernmentsubsidiesandtaxrelief.Fromtheperspectiveofvoluntarypolicytools,itissuggestedthatmarketsupervisionbeusedtostrengthentheself-disciplineofenterprisesandgivefullplaytotheroleofpharmaceuticalindustryassociations.Inshort,throughtheformationofmultitoolscollaborativesupervision,wewillgraduallyrealizethelong-termsupervisionmechanismofdrugsafetyinChina.KeywordsDrugsafety;Policytools;Multiplesupervision目录一、公共政策工具相关理论概述..............................1(一）政策工具的概念....................................1(二）政策工具的分类....................................1二、药品安全监管的现状与问题..............................3(一)药品安全监管的的现状..............................3(二)药品安全监管存在的问题............................3三、日本药品安全监管的实践探索............................5(一)日本药品安...
