[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"$fWtin9IWKXGj3VAChYNtcwd80FVwf5TOYT3EDTv5Te04":3},{"answer":4,"createTime":5,"id":6,"options":7,"origin":12,"question":19,"related":20,"source":24,"type":25},[],"2025-06-18 01:20:44",203201330,[8,9,10,11],"价格昂贵","药品可及性低","不同于原研药的给药途径","与原研药药具有相同的活性成分",{"count":13,"courseId":14,"courseImg":15,"courseName":16,"workId":17,"workName":18},337,"8e09f928906fdbfdc2fd50c78559fb3f","https:\u002F\u002Ftihai-oss-cloud.itihey.com\u002Fimg\u002F77e9e8ab3c7c2edfe53fbb2acf1fa6de.png","药事管理与法规","exam_162494545","项目八药品注册管理题库","仿制药的特点是",[21,26,36,45,50,58,67,73,82,91],{"answer":22,"createTime":5,"id":6,"options":23,"question":19,"source":24,"type":25},[],[8,9,10,11],"v1",0,{"answer":27,"createTime":28,"id":29,"options":30,"question":35,"source":24,"type":25},[],"2025-06-18 01:20:45",203201337,[31,32,33,34],"2年","10年","5年","1年","新药监测期的设立最长不得超过( )年",{"answer":37,"createTime":28,"id":38,"options":39,"question":44,"source":24,"type":25},[],203201343,[40,41,42,43],"20","15","60","30","国务院药品监督管理部门应当自受理临床试验申请之日起多少个工作日内决定是否同意并通知临床试验申 办者,途期未通知的,视为同意,申请人可按照提交的方案开展药物临床试验( )",{"answer":46,"createTime":28,"id":47,"options":48,"question":49,"source":24,"type":25},[],203201353,[33,31,34,32],"新药批准文号的有效期为",{"answer":51,"createTime":28,"id":52,"options":53,"question":57,"source":24,"type":25},[],203201359,[54,33,55,56],"6年","4年","3年","新药的临床监测期自该新药批准生产之日起计算不超过( )",{"answer":59,"createTime":28,"id":60,"options":61,"question":66,"source":24,"type":25},[],203201366,[62,63,64,65],"作者身份不明的作品著作权不受《著作权法》保护","保护期为作者终生加死后50年,截止于作者死亡后第50年的12月31日","作品自创作完成后50年内未发表的,仍受《著作权法》保护","作者的署名权.修改权.保护作品完整权受到保护期限限制","关于著作权保护,以下哪个选项是正确的( )",{"answer":68,"createTime":69,"id":70,"options":71,"question":72,"source":24,"type":25},[],"2025-06-18 01:20:53",203201378,[54,33,31,56],"药品注册证书有效期为",{"answer":74,"createTime":28,"id":75,"options":76,"question":81,"source":24,"type":25},[],203201396,[77,78,79,80],"国家药品监督管理局主管全国药品注册管理工作","国家药品监督管理局负责建立药品注册管理工作体系和制度,制定药品注册管理规范","药品审评中心负责药物临床试验申请.药品上市许可申请.补充申请和境外生产药品再注册申请等的审评","药品审评中心依法组织药品注册审评审批以及相关的监督管理工作","以下说法错误的是",{"answer":83,"createTime":28,"id":84,"options":85,"question":90,"source":24,"type":25},[],203201403,[86,87,88,89],"药品生产过程中的中等变更","药品说明书中所有内容的变更","药品生产过程中","药品生产过程中的微小变更","持有人应当在年度报告中报告的变更是( )",{"answer":92,"createTime":28,"id":93,"options":94,"question":99,"source":24,"type":25},[],203201410,[95,96,97,98],"4","3","5","6","含基本药物品种在内的仿制药,自首家品种通过一致性评价后,其他药品生产企业的相同品种原则上应在 几年内完成一致性评价( )"]