《中华人民共和国药品管理法》考点考试试题及答案

《中华人民共和国药品管理法》考点考试试题及答案一、单项选择题（每题1分，共30分。每题只有一个正确答案，请将正确选项字母填入括号内）1.根据《药品管理法》，国家对药品管理实行的首要原则是（）。A.安全有效B.风险管理C.全程管控D.社会共治答案：A2.药品上市许可持有人应当建立并实施的质量管理体系覆盖范围是（）。A.仅生产环节B.仅流通环节C.药品全生命周期D.仅研发环节答案：C3.药品上市许可持有人委托生产药品，应当向哪个部门备案（）。A.国家卫生健康委员会B.国家药品监督管理局C.省级药品监督管理部门D.设区的市级药品监督管理部门答案：C4.药品上市许可持有人应当每年向所在地省级药监部门提交的报告是（）。A.药品再注册申请B.药品年度报告C.药品质量回顾D.药品不良反应汇总答案：B5.下列属于假药的情形是（）。A.未标明有效期的药品B.擅自添加防腐剂的药品C.以非药品冒充药品D.超过有效期的药品答案：C6.下列属于劣药的情形是（）。A.药品所含成分与国家药品标准不符B.被污染的药品C.擅自添加着色剂的药品D.以他种药品冒充此种药品答案：C7.对生产、销售假药的单位，药品监督管理部门应当给予的行政处罚不包括（）。A.没收违法生产、销售的药品B.吊销药品生产许可证C.十年内不受理其药品上市许可申请D.对法定代表人处五日以下拘留答案：D8.药品上市许可持有人发现药品存在质量问题或者其他安全隐患，应当采取的强制措施是（）。A.主动召回B.责令召回C.评价召回D.二级召回答案：A9.药品网络交易第三方平台提供者应当对入驻的药品上市许可持有人或者药品经营企业进行的审核属于（）。A.形式审查B.实质审查C.备案管理D.事后抽查答案：B10.药品零售企业违反规定销售第二类精神药品，情节严重的，药品监督管理部门可以给予的处罚是（）。A.警告B.罚款五万元C.吊销药品经营许可证D.限制其法定代表人三年不得从事药品经营活动答案：C11.国家建立药品追溯制度，药品上市许可持有人应当建立并实施药品追溯体系，追溯体系应当实现的功能是（）。A.来源可查、去向可追B.风险可控、责任可究C.来源可查、去向可追、风险可控、责任可究D.来源可查、去向可追、价格可控答案：C12.药品上市许可持有人委托销售药品的，应当与受托方签订的书面合同应当报哪个部门备案（）。A.国家药监局B.省级药监局C.设区的市级药监局D.县级市场监管局答案：B13.药品注册分类中，中药创新药属于（）。A.中药1类B.中药2类C.中药3类D.中药5类答案：A14.药品上市许可持有人应当按照规定开展药品上市后研究，其中属于必须开展的是（）。A.Ⅳ期临床试验B.真实世界研究C.药品上市后安全性研究D.药品经济学评价答案：C15.药品生产企业变更生产地址，应当向哪个部门提出补充申请（）。A.国家药监局B.省级药监局C.设区的市级药监局D.原发证机关答案：D16.药品上市许可持有人应当建立药品不良反应报告和监测制度，其中应当报告所有不良反应的药品是（）。A.中药B.化学药品C.创新药D.仿制药答案：C17.药品上市许可持有人未按照规定提交年度报告，逾期不改正的，可以处以的罚款幅度为（）。A.一万元以上三万元以下B.五万元以上十万元以下C.十万元以上五十万元以下D.五十万元以上二百万元以下答案：C18.药品上市许可持有人、生产企业、经营企业、医疗机构应当建立并实施药品质量安全事件报告制度，事件发生后报告的时限为（）。A.24小时内B.48小时内C.72小时内D.7日内答案：A19.药品上市许可持有人应当制定药品召回计划，召回计划应当包括的内容不包括（）。A.召回药品的名称、批次B.召回原因C.召回分级D.召回药品的再销售方案答案：D20.药品网络销售不得经营的药品是（）。A.处方药B.非处方药C.医疗机构制剂D.中药饮片答案：C21.药品上市许可持有人应当建立药品质量档案，保存期限不得少于药品有效期后（）。A.1年B.2年C.3年D.5年答案：D22.药品上市许可持有人委托储存运输药品的，应当对受托方进行的质量审计周期为（）。A.每年至少一次B.每两年至少一次C.每三年至少一次D.每五年至少一次答案：A23.药品上市许可持有人应当建立药物警戒体系，药物警戒体系的核心是（）。A.药品不良反应收集B.药品风险评估C.药品风险管理D.药品风险沟通答案：C24.药品上市许可持有人应当建立药品安全委员会，药品安全委员会负责人应当由谁担任（）。A.质量负责人B.生产负责人C.企业负责人D.药物警戒负责人答案：C25.药品上市许可持有人应当建立药品追溯码，追溯码应当标识在药品最小销售单元以及其各级包装上的层级为（）。A.一级B.二级C.三级D.所有层级答案：D26.药品上市许可持有人应当建立药品短缺报告制度，其中应当向国家药监局报告的短缺药品是（）。A.所有药品B.国家短缺药品清单中的药品C.处方药D.创新药答案：B27.药品上市许可持有人应当建立药品年度报告制度，年度报告应当包括的内容不包括（）。A.药品生产、销售情况B.药品不良反应报告情况C.药品广告发布情况D.药品再注册申请情况答案：D28.药品上市许可持有人应当建立药品质量投诉管理制度，投诉处理记录保存期限不得少于（）。A.1年B.2年C.3年D.5年答案：D29.药品上市许可持有人应当建立药品召回制度，召回决定作出后应当通知相关经营企业和医疗机构的时限为（）。A.24小时内B.48小时内C.72小时内D.7日内答案：A30.药品上市许可持有人应当建立药品安全信息沟通制度，应当主动向社会公开的信息不包括（）。A.药品说明书修订内容B.药品召回信息C.药品生产批件D.药品不良反应评估结果答案：C二、多项选择题（每题2分，共20分。每题有两个或两个以上正确答案，多选、少选、错选均不得分）31.药品上市许可持有人应当履行的义务包括（）。A.药品全生命周期管理B.药品不良反应报告C.药品追溯体系建设D.药品广告审批答案：A、B、C32.下列属于药品上市许可持有人应当建立的制度有（）。A.药物警戒制度B.药品追溯制度C.药品召回制度D.药品价格谈判制度答案：A、B、C33.药品上市许可持有人委托生产药品，应当符合的要求包括（）。A.委托方和受托方签订质量协议B.受托方具有相应生产范围的生产许可证C.委托方向省级药监部门备案D.委托方可以委托任何企业生产答案：A、B、C34.药品上市许可持有人应当建立的药品追溯体系应当实现的功能包括（）。A.来源可查B.去向可追C.风险可控D.价格可降答案：A、B、C35.药品上市许可持有人应当报告的药品不良反应类型包括（）。A.新的不良反应B.严重不良反应C.群体不良事件D.所有不良反应答案：A、B、C36.药品上市许可持有人应当建立药品短缺报告制度，其中应当向国家药监局报告的情形包括（）。A.预计短缺B.已经短缺C.国家短缺药品清单中的药品D.所有药品答案：A、B、C37.药品上市许可持有人应当建立药品召回制度，召回分级包括（）。A.一级召回B.二级召回C.三级召回D.四级召回答案：A、B、C38.药品上市许可持有人应当建立药品质量投诉管理制度，投诉处理应当遵循的原则包括（）。A.及时B.准确C.公正D.保密答案：A、B、C、D39.药品上市许可持有人应当建立药品安全信息沟通制度，应当主动向社会公开的信息包括（）。A.药品说明书修订内容B.药品召回信息C.药品不良反应评估结果D.药品生产批件答案：A、B、C40.药品上市许可持有人应当建立药品年度报告制度，年度报告应当包括的内容有（）。A.药品生产、销售情况B.药品不良反应报告情况C.药品追溯体系建设情况D.药品广告发布情况答案：A、B、C三、填空题（每空1分，共20分）41.国家对药品管理实行________、________、________、________的原则。答案：安全有效、风险管理、全程管控、社会共治42.药品上市许可持有人应当建立并实施________管理体系，对药品的________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、________、______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