一次性使用无菌手术包类产品注册技术审查指导原则

一次性使用无菌手术包类产品注册技术审查指导原则 附件13 一次性使用无菌手术包类产品注册技术审查指导原则 本指导原则旨在指导和规范一次性使用无菌手术包类产品的技术审评工作～帮助审评人员理解和掌握该类产品原理/机理、结构、性能、预期用途等内容～把握技术审评工作基本要求和尺度～对产品安全性、有效性作出系统评价。 本指导原则所确定的核心内容是在目前的科技认识水平和现有产品技术基础上形成的～因此～审评人员应注意其适宜性～密切关注适用及相关技术的最新进展～考虑产品的更新和变化。 本指导原则不作为法规强制执行～不包括行政审批要求。但是～审评人员需密切关注相关法规的变化～以确认申报产品是否符合法规要求。 一、适用范围 本指导原则适用于根据临床需求～将医疗器械产品包装在一起的一次性使用无菌器械包类产品,以下简称手术包,。 本指导原则不适用于含有?类医疗器械产品的手术包。 二、技术审查要点 ,一,产品名称的要求 产品的名称应以体现产品组成、功能用途为基本原则。手术包是根据临床需求将不同的医疗器械产品组成医疗器械包～包内的组件可以由不同生产制造商提供～并且组件名称也不同～但组 1 成手术包后就只能有一个产品名称～一般应以其主要预期用途来命名～如:用于外科手术的包就称作手术包～用于产科手术的包就称为产包～用于导尿的包就称作导尿包。 手术包类产品均为一次性使用～产品名称中应加入“一次性使用”字样～是无菌级别的应加入“无菌”字样～如“一次性使用无菌手术包”、“一次性使用无菌产包”。 ,二,产品的结构和组成 手术包组成,一般以组件形式体现,应满足以下条件: 第一～组件不应含有药物,如酒精、灌洗创口用生理盐水等,。手术包组件管理类别最高为二类。 第二～组件可以是外购具有医疗器械注册证的产品～如外购的外科手术口罩、手套等。作为手术包的组件其预期用途不应改变～应与审批通过的预期用途一致。 第三～组件可以是尚未注册的医疗器械产品。作为手术包的组件时其安全有效性要求应与单独注册该组件基本一致～如导尿包中的导尿管～应符合单独注册导尿管的技术审评要求。 第四～手术包必须包含在其申报的生产地址所生产的二类组件～如手术包企业生产的手术衣等。 常见的手术包组件有:手术衣、帽子、口罩、洞巾、大单、中单、小单、手套、脱脂纱布等。 依据临床用途的不同～不同注册单元的手术包配臵也不同～如一次性使用无菌产包可配臵产垫等,一次性使用无菌导尿包可 2 配臵导尿管等。 ,三,产品工作原理 手术包由多种组件组成～每种组件有各自的工作原理～故不在此分别描述。 ,四,产品作用机理 因该产品为非治疗类医疗器械～故本指导原则不包含产品作用机理的内容。 ,五,产品适用的相关标准 表1 相关产品标准 GB/T 191-2008 包装储运图示标志 GB 7543-2006 一次性使用灭菌橡胶外科手套 GB/T 14233.1-2008 医用输血、输液、注射器具检测方法 第1部分:化学方 法 GB/T 14233.2-2008 医用输血、输液、注射器具检测方法 第2部分:生物试验方 法 GB 15980,1995 一次性使用医疗用品卫生标准 GB/T 16886.1-2011 医疗器械生物学评价 第1部分:评价与试验 GB/T 16886.7-2001 医疗器械生物学评价 第7部分:环氧乙烷灭菌残留量 GB/T 16886.10-2005 医疗器械生物学评价 第10部分:刺激与迟发型超敏反应试 验 GB 18278-2000 医疗保健产品灭菌确认和常规控制要求 工业湿热灭菌 GB 18279-2000 医疗器械 环氧乙烷灭菌确认和常规控制 GB 18280-2000 医疗保健产品灭菌确认和常规控制要求 辐射灭菌 GB/T 19633-2005 最终灭菌医疗器械的包装 YY 0043-2005 医用缝合针 YY 0166-2002 医用带线缝合针 3 YY 0167-2005 非吸收性外科缝线 YY 0174-2005 手术刀片 YY 0175-2005 手术刀柄 YY/T 0313-1998 医用高分子制品包装、标志、运输和贮存 YY 0330-2002 医用脱脂棉 YY 0331-2006 医用脱脂纱布、脱脂棉粘胶混纺纱布的性能要求和试验方法 YY/T 0454-2008 无菌塑柄手术刀 YY/T 0466.1-2009 医疗器械 用于医疗器械标签、标记和提供信息的符号 YY 0469-2004 医用外科口罩技术要求 YY/T 0506.1-2005 病人、医护人员和器械用手术单、手术衣和洁净服第1部分: 制造厂、处理厂和产品的通用要求 YY/T 0506.2-2009 病人、医护人员和器械用手术单、手术衣和洁净服第2部分: 性能要求和性能水平 YY/T 0506.3-2005 病人、医护人员和器械用手术单、手术衣和洁净服第3部分: 试验方法 YY/T 0506.4-2005 病人、医护人员和器械用手术单、手术衣和洁净服第4部分: 干态落絮试验方法(ISO 9073-10:2003,IDT) YY/T 0 506.5-2009 病人、医护人员和器械用手术单、手术衣和洁净服第5部分: 阻干态微生物穿透试验方法 YY/T 0506.6-2009 病人、医护人员和器械用手术单、手术衣和洁净服第6部分: 阻湿态微生物穿透试验方法 YY 0594-2006 外科纱布敷料通用要求 YY/T 0720-2009 一次性使用产包 自然分娩用 YY/T 0615.1-2007 标示“无菌”医疗器械的要求 第1部分:最终灭菌医疗器械 的要求 中华人民共和国药典,2010版, 注:手术包组件范围可能不局限于上述标准范围～故应引用手术包内所有组件相关的标准。 产品适用及引用标准的审查可以分两步来进行。首先对引用标准的齐全性和适宜性进行审查～也就是在编写注册产品标准时 4 是否引用与产品相关的国家标准、行业标准～以及引用是否准确。可以通过对注册产品标准中“规范性引用文件”是否引用了相关标准～以及所引用的标准是否适宜来进行审查。此时～应注意标准编号、标准名称是否完整规范～年代号是否有效。 其次对引用标准的采纳情况进行审查。即所引用标准中的条款～是否在注册产品标准中进行了实质性的条款引用。这种引用通常采用两种方式～内容繁多的、复杂的可以直接引用标准及条文号～比较简单的也可以直接引述具体要求。 如有新版强制性国家标准、行业标准发布实施～应执行最新版本的国家标准、行业标准。 ,六,产品的预期用途 用于实现特定的临床目的。如:手术包用于临床手术防护～导尿包用于临床导尿使用。 ,七,产品的主要风险 1.风险分析方法 ,1,在对风险的判定及分析中～要考虑合理的可预见的情况～包括:正常使用条件下和非正常使用条件下。 ,2,风险判定及分析应包括:对于患者的危害、对于操作者的危害和对于环境的危害。 ,3,风险形成的初始原因应包括:人为因素～产品结构的危害～原危害～综合危害～环境条件。 ,4,风险判定及分析考虑的问题包括:手术包原材料生物学危害,产品质量是否会导致使用中出现不正常结果,操作信息～包括警示性语言、注意事项以及使用方法的准确性,使用过程可 5 能存在的危害等。 2.风险分析清单 手术包产品的风险管理应符合YY/T 0316-2008《医疗器械 风险管理对医疗器械的应用》的有关要求～审查要点包括: ,1,产品定性定量分析是否准确,依据YY/T 0316-2008 附录C,, ,2,危害分析是否全面,依据YY/T 0316-2008附录E,, ,3,风险可接收准则～降低风险的措施及采取措施后风险的可接收程度～是否有新的风险产生。 根据YY/T 0316-2008《医疗器械 风险管理对医疗器械的应用》附录E对该产品已知或可预见的风险进行判定～手术包产品在进行风险分析时至少应包括对以下的主要危害～企业还应根据自身产品特点确定其他危害。针对产品的各项风险～企业应采取应对措施～确保风险降到可接受的程度。 表2 产品主要危害 产生的后果 危害类型 可预见的事件及事件序列 危害处境 或损害 中毒、刺激过敏等产品材料的选择未经生物学生物不相容的症状～损害患者健生物学危害 评价或使用生物不相容的材材料与患者接康～严重时危及患料 触 者生命 患者被细菌感染～灭菌工艺未确认～或未按已患者使用了有生物学危害 严重时导致发热、确认的工艺实施灭菌 菌的产品 休克 对环氧乙烷残留量的控制未 能按标准确认～或未能按确超量的环氧乙化学危害 认的结果实施控制～解析不损害患者健康 烷输入人体 彻底～致使环氧乙烷残留量 超标 6 未能按运输、储存要求对产患者被细菌感染～患者使用了有生物学危害 品防护～造成产品包装破损～严重时导致发热、菌的产品 产品被污染 休克 患者被细菌感染～患者使用了有生物学危害 超过灭菌有效期的产品带菌 严重时导致发热、菌的产品 休克 在标识的灭菌有效期到期患者被细菌感染～患者使用了有生物学危害 前～包装材料老化已不能保严重时导致发热、菌的产品 持无菌 休克 患者被细菌感染～患者使用了有生物学危害 产品被重复使用 严重时导致发热、菌的产品 休克 造成人员感染,有产品使用后～未按医疗垃圾有害有毒物质生物学危害 时是大面积,～或处理 影响环境 环境被破坏 患者被细菌感染～产品的使用人员未接受培训 患者使用了有运行危害 严重时导致发热、使用产品时操作不当 菌的产品 休克 使用了不符合 产品标识和说明书不符合规要求的产品或人员感染、 信息危害 定 产品使用处臵破坏环境 不当 生产环境未按《无菌医疗器 械生产质量管理规范》中的患者被细菌感染～生物或化学患者使用了有要求进行控制～或环氧乙烷严重时导致发热、危害 菌的产品 灭菌器未按要求验证～或解休克 析时间未达到要求 ,八,产品的主要技术指标 本章给出手术包产品需要考虑的基本技术性能指标～企业可参考相应的标准～根据企业自身产品的技术特点和用途制定相应的性能指标。如国家标准中有不适用条款～企业在标准的编制说明中必须说明理由。 1. 无菌要求 每个经单包装的手术包应通过一灭菌确认的过程和常规控制使产品无菌。,注:按《中华人民共和国药典》,2010年版,“无 7 菌检查法”规定执行,。 2. 残留量要求 若产品经环氧乙烷灭菌～环氧乙烷残留量应不大于10μg/g。 3. 生物性能要求 应根据组件接触人体的部位和时间～依据GB/T 16886.1标准进行评价。一般要求至少包括对皮肤应无刺激、迟发型超敏反应、细胞毒性。 4. 组件要求 ,1,手术单、手术衣和洁净服应符合YY/T 0506.2-2009标准的相关规定。 ,2,一次性使用灭菌橡胶外科手套应符合GB 7543-2006标准的相关规定。 ,3,医用脱脂纱布辅料应符合YY 0594-2006标准的相关规定。 ,4,医用脱脂棉应符合YY 0330-2006标准的相关规定。 ,5,医用缝合针应符合YY 0043-2005标准的相关规定。 ,6,医用带线缝合针应符合YY 0166-2002标准的相关规定。 ,7,医用外科口罩应符合YY 0469-2004标准的相关规定。 ,8,其他组件应符合其适用的国家标准或行业标准。 5. 其他说明 若组件为外购件～在审查其技术要求时需要考虑生产过程对组件性能的影响～一般分两种情况: ,1,未经二次灭菌的组件～性能要求可为“具有医疗器械注册证产品”～试验方法可采用“提供产品注册证及由具有资质检验机构出具的效期内检验报告”。 ,2,经二次灭菌的组件～考虑到二次灭菌对产品性能可能造 8 成的影响～性能要求应在注册产品标准中规定～试验方法可采用“按照标准的规定进行检验”。 ,九,产品的检验要求 产品的检验包括出厂检验和型式检验。 出厂检验应至少包括环氧乙烷残留量,若采用环氧乙烷灭菌,、无菌。 外购件的检验方式如果是以供方提供资质证明和有效期内的检验报告方式提供～则检验机构在核准确认后应将供方提供资质证明和有效期内的检验报告附于注册检验报告之后。 ,十,产品的临床要求 手术包产品的临床要求应以其中的组件组成情况来确定～一般分两种情况。 若手术包中的二类医疗器械组件均在《豁免提交临床试验资料的第二类医疗器械目录,试行,》范围内～生产企业在申报以上组件的手术包时～可以书面申请免于提交临床试验资料～但应同时提交申报产品与已上市同类产品的对比说明。对比说明应当包括产品材质、结构组成、主要技术性能指标、灭菌方法、预期用途等内容。 若手术包中的二类医疗器械组件有不在《豁免提交临床试验资料的第二类医疗器械目录,试行,》范围内～则手术包需要按照《医疗器械注册管理办法》中的相关规定提交临床试验资料。 ,十一,产品的不良事件历史 暂未见相关报道。 ,十二,产品说明书、标签和包装标识 9 手术包的说明书、标签和包装标识应符合《医疗器械说明书、标签和包装标识管理规定》和YY/T 0466.1《医疗器械 用于医疗器械标签、标记和提供信息的符号》的要求。同时应注意根据手术包中不同的组件审查是否有相应的内容。 1.说明书的内容 手术包的说明书应包括产品名称、商品名称,若有,、规格、型号、组件的组成与数量及与人体接触组件的原材料、性能指标、适用范围、使用方法、注意事项、标签和包装标识、医疗器械生产企业名称、注册地址、生产地址、联系方式、售后服务方式、医疗器械生产企业许可证号、医疗器械注册证号、产品标准号、产品有效期限、医疗器械标签所用的图形和符号的解释、产品维护和保养方法以及储存条件。 2. 说明书审查关注点 说明书应审查其内容与注册产品标准及其他申报材料中内容是否一致: ,1,手术包的名称、规格、型号、组件的组成与数量、性能指标应与注册产品标准内容一致。 ,2,所有组件必要说明的信息。如含外购组件～应公布外购组件的制造商信息及其说明书的全部信息。 ,3,手术包的适用范围应与注册申请表、注册产品标准一致。 ,4,生产企业名称、注册地址、生产地址、联系方式及售 10 后服务方式应真实并与《医疗器械生产企业许可证》、《企业法人营业执照》一致。 ,5,说明书文字表述应容易理解、简明扼要且无广告性语言。图形符号的说明符合YY/T 0466.1中的规定。 ,6, 说明书的注意事项应包括以下内容: 产品的使用方法按手术室无菌操作规定使用,包装破损切勿使用,一次性产品切勿再次使用,使用后处理方式。 3. 产品的标签、包装标识应审查以下内容: ,1,产品名称、规格、型号、内部组件的组成与数量, ,2,生产日期及批次代码, ,3,生产企业名称、注册地址、生产地址、联系方式, ,4,医疗器械注册证号、产品标准号, ,5,产品的有效期限, ,6,包装破损切勿使用, ,7,文字标明产品为“一次性使用无菌产品”～或符号标明“切勿再次使用”与“无菌”, ,8,产品使用后的处理方式, ,9,产品灭菌方式～若经环氧乙烷灭菌～应标明残留量限度, ,10,依据产品组件的特性应当标注的图形、符号以及其他相关内容。 ,十三,注册单元划分的原则和实例 11 注册单元划分应按照医疗器械注册管理办法第二十七条要求～“医疗器械产品的注册单元原则上以产品组成、性能指标和预期用途为划分依据”实施。 手术包注册单元的划分应首先考虑预期用途。预期用途不同的手术包不作为同一单元～例如“一次性使用无菌产包”和“一次性使用无菌导尿包”。 其次考虑包内组件。组件种类、主要原材料、主要性能相同～仅规格或数量不同～则可以作为一个注册单元。 ,十四,同一注册单元中典型产品的确定原则和实例 1(同一注册单元中典型产品是指能够代表本注册单元内其他产品安全性和有效性的产品～其功能最齐全～结构最复杂～风险最高。 2(典型产品的确定可以通过比较同一注册单元内所有产品的技术结构、性能指标和预期用途等相应资料～说明能够代表本注册单元内其他产品的安全性和有效性。 3(举例 ,1,包含高性能手术单的一次性使用无菌手术包与包含标准性能手术单的一次性使用无菌手术包相比～高性能手术衣性能指标要求更高。所以包含高性能手术单的一次性使用无菌手术包应作为这个注册单元中的典型产品。 ,2,同一单元中～组件多的手术包覆盖组件少的手术包～故选择组件多的手术包作为典型产品。 三、审查关注点 手术包根据其产品特点和生产过程,如下图,～应在审评时重点把握三个要素～即组件、生产过程和说明书。 12 ,一,产品组件 手术包的安全、有效～主要取决于其组件是否安全、有效～故审查时应重点审查手术包组件清单。在清单中～重点把握组件来源,标明是否本企业生产或者外购,、外购组件状态,产品性能是否完整、是否有包装及标志、是否灭菌、是否有上市信息,、组件生产过程,加工、灭菌、包装,～可参考附件《手术包组件清单》。 对于未经批准上市的组件～其审查与该组件单独申报注册的要求基本一致。对已有医疗器械注册证的产品若产品经再处理有改变原批准性能要求的情况应对其风险进行控制。 ,二,生产过程 应审查手术包工艺流程～重点把握特殊过程如灭菌和包装。 1.灭菌过程 审查手术包采取的灭菌方法是否适用于其组件～例如:一般认为环氧乙烷灭菌不适用于纱布敷料～因为环氧乙烷残留在纱布中难以解析到安全水平。 同时可审查主要灭菌过程参数。如～环氧乙烷灭菌参数包括预真空压力、温度、湿度、压力、环氧乙烷纯度及浓度、灭菌时间、解析时间和温度、装载模式,钴-60Υ射线辐照灭菌参数包括辐照剂量、辐照时间、装载模式。必要时可审查灭菌过程确认 13 报告。 2.包装过程 审查包装材料的选择～应考虑材料的理化性能、毒性、微生物阻隔性能、与灭菌过程的适应性、灭菌后的效期。技术报告中应提供无菌有效期验证资料。 应在技术报告中提供运输、存储中产品无菌包装是否完好的验证情况,参考YY/T 0681《无菌医疗器械包装材料试验方法》,。 3.二次灭菌的影响 二次灭菌是指手术包组件经同一灭菌方式或不同灭菌方式的再次灭菌～这是由于手术包组件多数为外购产品～部分外购产品出厂前本身已经经过灭菌。 因二次灭菌可能影响组件的外观、形态及性能～如钴-60Υ射线辐照灭菌致高分子材料组件的力学性能下降。故审查时应评价二次灭菌后的组件性能是否符合相关标准要求及临床需求。 4.效期 手术包的有效期以组件中最短有效期为最终产品有效期。对于外购件～需要考虑组件购买时的剩余效期及影响效期主要因素～如材料老化、灭菌有效期等～应审评技术报告中的效期验证相关资料。 ,三,说明书和标签 审查时主要遵循“信息量”原则～即手术包说明书和标签的提示信息不得少于其所有组件原包装提供的提示信息。如～导尿 14 包的说明书至少应包括导尿管的提示信息～如结构组成、性能指标、使用方法、注意事项等。手术包中如有特殊运输贮存要求的组件～应对运输贮存条件进行说明。 15 附件 手术包组件清单 外购组件状态 组件生产过程及该过 程对组件安全有效的组件名称 组件来源 是否 包装、效批准上影响 灭菌 标志 期 市信息 16 一次性使用无菌手术包类产品注册技术审查指导原则 编制说明 一、指导原则编写的原则 ,一,本指导原则编写的目的是用于指导和规范一次性使用无菌手术包类产品注册申报过程中审查人员对注册材料的技术审评。 ,二,本指导原则旨在让初次接触该类产品的注册审查人员对产品机理、结构、主要性能、预期用途等各个方面有个基本了解～同时让技术审查人员在产品注册技术审评时把握基本的尺度～对产品安全性、有效性作出系统评价。 二、指导原则编写的依据 ,一,《医疗器械监督管理条例》 ,二,《医疗器械注册管理办法》,国家食品药品监督管理局令第16号, ,三,《医疗器械临床试验规定》,国家食品药品监督管理局令第5号, ,四,《医疗器械说明书、标签和包装标志管理规定》,国家食品药品监督管理局令第10号, ,五,《医疗器械标准管理办法》,国家药品监督管理局令第31号, ,六,关于印发豁免提交临床试验资料的第二类医疗器械目录,试行,的通知,国食药监械„2011?475号, ,七,国家食品药品监督管理部门发布的其他规范性文件 17 三、指导原则中部分具体内容的编写考虑 ,一,指导原则的范围 本指导原则虽然名称仅体现手术包～但实际在编写中考虑的是全部与手术包具有相同特征的产品。因此～我国临床中使用的手术包、产包、导尿包、备皮包等都是本指导原则的编写范围。这种编写方式参考了美国食品药品管理局对这类产品的管理～其出发点是这类产品都有共同的特征～即都是根据临床需求～将两种以上医疗器械产品包装在一起的“器械包”。 综上～在“一、适用范围”中未规定类代号～因为具体类别代号应依据包内起到预期用途的主要组件的管理类代号。 ,二,产品组件 在全文中多次使用的“组件”～是指手术包内的医疗器械产品。美国食品药品管理局允许全部组件都是外购产品～而且组件可以是上市最终包装形式或者未经最终灭菌包装的“批发”形式。但考虑到我国实际情况以及由此带来的风险～综合考虑审校会上各省代表意见～在编写时定为“必须包含在其申报的生产地址所生产的二类组件”～即至少有一个二类组件是由企业生产。同时～不主张组件中包含“不是医疗器械产品”的组件～如刷子。 ,三,产品生产过程 手术包的生产过程～尤其灭菌、残留量解析、包装、效期是影响产品安全、有效的重要因素～在审查时应了解和评价。考虑到我国已经实施医疗器械生产质量管理规范～上述生产过程的验证和确认主要在质量体系考核中进行～故编写时未进行深入阐述。 18 ,四,产品说明书和标签 正文中提到审查时主要遵循“信息量”原则～在实际审评工作中可能不易操作～但从控制产品使用风险角度是十分必要的。可以考虑要求申报企业提交其外购组件的原说明书～作为审查依据。 四、相关参考资料 本指导原则在编写过程中主要研究和参考了美国食品药品管理局的相关指导原则～主要有1997年发布《Convenience Kits - Interim Regulatory Guidance》～2002年发布《Sterilized Convenience Kits for Clinical and Surgical Use - Final Guidance for Industry》。同时也借鉴了原北京药品监督管理局发布的《一次性使用器械包类产品技术审评规范,2009版,》～在此表示感谢。 五、指导原则编写人员 本指导原则的编写成员由辽宁省食品药品监督管理局医疗器械产品注册技术审评人员和行政审批人员、国家食品药品监督管理局沈阳医疗器械质量监督检验中心人员组成～以充分利用各方面的信息和资源～综合考虑指导原则中各个方面的内容～尽量保证指导原则正确、全面、实用。 19 (英文版 ) Two regulations promulgated for implementation is in the party in power for a long time and the rule of law conditions, the implementation of comprehensive strictly strategic plan, implementation in accordance with the rules and discipline to manage the party, strengthen inner-party supervision of major initiatives. The two regulations supporting each other, the < code > adhere to a positive advocate, focusing on morality is of Party members and Party leading cadres can see, enough to get a high standard; < rule > around the party discipline, disciplinary ruler requirements, listed as "negative list, focusing on vertical gauge, draw the party organizations and Party members do not touch the" bottom line ". Here, the main from four square face two party rules of interpretation: the first part introduces two party Revised regulations the necessity and the revision process; the second part is the interpretation of the two fundamental principles of the revision of laws and regulations in the party; the third part introduces two party regulations modified the main changes and needs to grasp several key problems; the fourth part on how to grasp the implementation of the two regulations of the party. < code > and < Regulations > revised the necessity and revised history of the CPC Central Committee the amendment to the Chinese Communist Party members and leading cadres honest politics several guidelines > and < Chinese Communist Party discipline and Punishment Regulations > column 1 by 2015 to strengthen 20 party laws and regulations focus. Two party regulations revision work lasted a Years, pooling the wisdom of the whole party, ideological consensus, draw historical experience, respect for the wisdom of our predecessors, which reflects the unity of inheritance and innovation; follow the correct direction, grasp the limited goals, adhere to the party's leadership, to solve the masses of the people reflect a focus on the problem. The new revision of the < code > and < rule >, reflects the party's 18 and the eighth session of the third, the spirit of the fourth plenary session, reflecting the experience of studying and implementing the General Secretary Xi Jinping series of important speech, reflects the party's eighteen years comprehensive strictly practice. (a) revised two regulations of the party need of < the ICAC guidelines > in < in 1997 Leaders as members of the Communist Party of China clean politics certain criteria (Trial) > based on revised, the promulgation and implementation of January 2010, to strengthen the construction of the contingent of leading cadres play an important role. But with the party to manage the party strictly administering the deepening, has not been able to fully meet the actual needs. Content is too complicated, "eight prohibition, 52 are not allowed to" hard to remember, and also difficult to put into practice; the second is concisely positive advocated by the lack of prohibited provisions excessive, no autonomy requirements; the third is banned terms and discipline law, both with the party discipline, disciplinary regulations 21 repeat and Criminal law and other laws and regulations repeat; the fourth is to "clean" the theme is not prominent, not for the existing problems, and is narrow, only needle of county-level leading cadres above. < rule > is in 1997 < Chinese Communist Party disciplinary cases (Trial) > based on revision, in December 2003 the promulgation and implementation, to strengthen the construction of the party play very important role. Along with the development of the situation, which many provisions have been unable to fully meet the comprehensive strictly administering the practice needs. One is Ji law, more than half of the provisions and criminal law and other countries laws and regulations Repetition; two is the political discipline regulations is not prominent, not specific, for violation of the party constitution, damage the authority of Party Constitution of misconduct lack necessary and serious responsibility to pursue; third is the main discipline for the leading cadres, does not cover all Party members. Based on the above situation, need to < the criterion of a clean and honest administration > and < rule > the two is likely to be more relevant regulations first amendment. By revising, really put the authority of Party discipline, the seriousness in the party tree and call up the majority of Party members and cadres of the party constitution of party compasses party consciousness. (II) two party regulations revision process the Central Committee of the Communist Party of China attaches great importance to two regulations revision . Xi Jinping, general books recorded in the Fifth 22 Plenary Session of the eighth session of the Central Commission for Discipline Inspection, on the revised regulations < > made clear instructions. According to the central deployment, the Central Commission for Discipline Inspection from 2014 under six months begin study two regulations revision. The Standing Committee of the Central Commission for Discipline Inspection 4 review revised. Comrade Wang Qishan 14 times held a special meeting to study two regulations revision, amendment clarifies the direction, major issues of principle, path and target, respectively held a forum will listen to part of the province (area) secretary of the Party committee, Secretary of the Discipline Inspection Commission, part of the central ministries and state organs Department The first party committee is mainly responsible for people, views of experts and scholars and grassroots party organizations and Party members. Approved by the Central Committee of the Communist Party of China, on 7 September 2015, the general office of the Central Committee of the Party issued a notice to solicit the provinces (autonomous regions, municipalities) Party, the central ministries and commissions, state ministries and commissions of the Party (party), the General Political Department of the military, every 3 people organization of Party of two regulations revision opinion. Central Commission for Discipline Inspection of extensive solicitation of opinions, careful study, attracting, formed a revised sent reviewers. In October 8 and October 12, Central Committee Political 23 Bureau Standing Committee and the Political Bureau of the Central Committee After consideration of the two regulations revised draft. On October 18, the Central Committee of the Communist Party of China formally issued two regulations. Can say, two laws amendment concentrated the wisdom of the whole party, embodies the party. Second, < code > and < Regulations > revision of the basic principles of two party regulations revision work and implement the party's eighteen, ten eight plenary, the spirit of the Fourth Plenary Session of the Eleventh Central Committee and General Secretary Xi Jinping important instructions on the revised < low political criterion > and < Regulations >, highlighting the ruling party characteristics, serious discipline, the discipline quite in front of the law, based on the current, a long-term, advance as a whole, with Bu Xiuding independent < rule > and < rule >. Main principle is: first, adhere to the party constitution to follow. The constitution about discipline and self-discipline required specific, awaken the party constitution of party compasses party consciousness, maintaining the authority of the constitution. General Secretary Xi Jinping pointed out that "no rules, no side round. Party constitution is the fundamental law, the party must follow the general rules. In early 2015 held the eighth session of the Central Commission for Discipline Inspection Fifth Plenary Session of the 16th Central Committee, Xi Jinping again pointed out that constitution is the party must follow the general rules, but also the general rules." the revision 24 of the < code > and < rule > is Method in adhere to the regulations established for the purpose of combining rule of virtue is to adhere to the party constitution as a fundamental to follow, the constitution authority set up, wake up the party constitution and party rules the sense of discipline, the party constitution about discipline and self-discipline specific requirements. 4 second is to adhere to in accordance with the regulations governing the party and the party. The Party of rule of virtue "de", mainly refers to the party's ideals and beliefs, excellent traditional style. The revised the < code > closely linked to the "self-discipline", insisting on the positive initiative, for all members, highlight the "vital few", emphasized self-discipline, focusing on the morality, and the majority of Party members and the ideological and moral standards. The revised < > Ji method separately, Ji, Ji Yan to Method, as a "negative list", emphasizing the heteronomy, focusing on vertical gauge. Is this one high and one low, a positive reaction, the strict party discipline and practice results transformation for the integration of the whole party to observe moral and discipline requirements, for the majority of Party members and cadres provides benchmarking and ruler. Third, insist on to. In view of the problems existing in the party at the present stage, the main problems of Party members and cadres in the aspect of self-discipline and abide by the discipline to make clearly defined, especially the party's eighteen years strict political discipline and political rules, organization and discipline and 25 to implement the central eight provisions of the spirit against the four winds and other requirements into Disciplinary provisions. Not one pace reachs the designated position, focusing on in line with reality, pragmatic and effective. After the revision of major changes, major changes in the < code > and < rule > modified and needs to grasp several key problems (a) < code > < code > adhere to according to regulations governing the party and party with morals in combination, for at the present stage, the leadership of the party members and cadres and Party members in existing main problems of self-discipline, put forward principles, requirements and specifications, showing Communists noble moral pursuit, reflected at all times and in all over the world ethics from high from low 5 common requirements. One is closely linked to the "self-discipline", removal and no direct relation to the provisions of . the second is adhere to a positive advocate, "eight prohibition" 52 are not allowed to "about the content of the" negative list moved into synchronization amendment < cases >. Three is for all the party members, will apply object from the leadership of the party members and cadres to expand to all Party members, fully embodies the comprehensive strictly required. The fourth is prominent key minority, seize the leadership of the party members and cadres is the key, and put forward higher requirements than the ordinary Party members. Five is to simplify, and strive to achieve concise, easy to understand, easy to remember. The revised < code > is the ruling Party since the first insists on 26 a positive advocate forAll Party members and the self-discipline norms, moral declaration issued to all members of the party and the National People's solemn commitment. > < criterion of a clean and honest administration consists of 4 parts, 18, more than 3600 words. After the revision of the < code >, a total of eight, 281 words, including lead, specification and Party member cadre clean fingered self-discipline norms, etc. Part 3 members low-cost clean and self-discipline, the main contents can be summarized as "four must" "eight code". Lead part, reiterated on ideal and faith, fundamental purpose, the fine traditions and work style, noble sentiments, such as "four must" the principle of requirements, strong tone of self-discipline, The higher request for 6 and supervised tenet, the foothold in permanent Bao the party's advanced nature and purity, to reflect the revised standards requirements. Members of self-discipline norms around the party members how to correctly treat and deal with the "public and private", "cheap and rot" thrifty and extravagance "bitter music", put forward the "four norms". Party leader cadre clean fingered self-discipline norms for the leadership of the party members and cadres of the "vital few", around the "clean politics", from civil servant of the color, the exercise of power, moral integrity, a good family tradition and other aspects of the leadership of the party members and cadres of the "four norms" < > < norm norm. "The Party member's self-discipline norms" and "party members and leading cadre clean fingered self-discipline norms," a 27 total of eight, collectively referred to as the "eight". "Four must" and "eight" of the content from the party constitution and Party's several generation of leaders, especially Xi Jinping, general secretary of the important discussion, refer to the "three discipline and eight points for attention" statements, and reference some embody the Chinese nation excellent traditional culture essence of epigrams. (2) the revised regulations, the main changes in the revised Regulations > to fully adapt to the strictly requirements, reflects the according to the regulations governing the law of recognition of deepening, the realization of the discipline construction and Jin Ju. < rule > is party a ruler, members of the basic line and follow. And the majority of Party members and cadres of Party organizations at all levels should adhere to the bottom line of thinking, fear discipline, hold the bottom line, as a preventive measure, to keep the party's advanced nature and purity. 1, respect for the constitution, refinement and discipline. Revised < rule > from comprehensive comb physical constitution began, the party constitution and other regulations of the Party of Party organizations and Party discipline requirements refinement, clearly defined in violation of the party constitution will be in accordance with regulations to give the corresponding disciplinary action. The original 10 categories of misconduct, integration specification for political discipline, discipline, honesty and discipline masses Ji Law and discipline and discipline and other six categories, the content of < rule > 28 real return to Party discipline, for the majority of Party members and listed a "negative list. 7 2, highlighting the political discipline and political rules. > < Regulations according to the stage of the discipline of outstanding performance, emphasizing political discipline and political rules, organization and discipline, in opposition to the party's leadership and the party's basic theory, basic line, basic program and basic experience, the basic requirement of behavior made prescribed punishment, increase the cliques, against the organization such as violation of the provisions, to ensure that the central government decrees and the Party of centralized and unified. 3, adhere to strict discipline in the law and discipline In front, Ji separated. Revised < Regulations > adhere to the problem oriented, do Ji separated. Any national law existing content, will not repeat the provisions, the total removal of 79 and criminal law, repeat the content of the public security management punishment law, and other laws and regulations. In the general reiterated that party organizations and Party members must conscientiously accept the party's discipline, die van comply with national laws and regulations; at the same time, to investigate violations of Party members and even criminal behavior of Party discipline and responsibility, > < Regulations distinguish five different conditions, with special provisions were made provisions, so as to realize the connection of Party discipline and state law. 4, reflect Wind building and anti-corruption struggle of the latest achievements. < rule > the party's eighteen years 29 implement the spirit of the central provisions of the eight, against the requirements of the "four winds" and transformation for disciplinary provisions, reflecting the style construction is always on the road, not a gust of wind. In the fight against corruption out of new problems, increase the trading rights, the use of authority relatives profit and other disciplinary terms. Prominent discipline of the masses, the new against the interests of the masses and ignore the demands of the masses and other disciplinary terms and make provisions of the disposition and the destruction of the party's close ties with the masses. Discipline to protect the party's purpose. 8 of these regulations, a total of three series, Chapter 15, 178, more than 24000 words, after the revision of the regulations a total of 3 series, Chapter 11, 133, 17000 words, divided into "general" and "special provisions" and "Supplementary Provisions" Part 3. Among them, add, delete, modify the provisions of the proportion of up to nearly 90%. 1, the general general is divided into five chapters. The first chapter to the regulations of the guiding ideology, principles and scope of application of the provisions, highlight the strengthening of the party constitution consciousness, maintenance the authority of Party Constitution, increase the party organizations and Party members must abide by the party constitution, Yan Centralized centralized, would examine at all levels of the amended provisions implementing and maintaining Party discipline, and consciously accept the party discipline, 30 exemplary compliance with national laws and regulations. The second chapter of discipline concept, disciplinary action types and effects of the regulations, will be a serious warning from the original a year for a year and a half; increase the Party Congress representative, by leaving the party above (including leave probation) punishment, the party organization should be terminated its representative qualification provisions. The third chapter of the disciplinary rules of use prescribed in the discipline rectifying process, non convergence, not close hand classified as severely or heavier punishment. "Discipline straighten "At least eighteen years of five years, these five years is to pay close attention to the provisions of the central eight implementation and anti -" four winds ". The fourth chapter on suspicion of illegal party disciplinary distinguish five different conditions, with special provisions were made provisions, to achieve effective convergence of Party and country 9 method. < rule > the provisions of Article 27, Party organizations in the disciplinary review found that party members have committed embezzlement, bribery, dereliction of duty dereliction of duty and other criminal law act is suspected of committing a crime shall give cancel party posts, probation or expelled from the party. The second is < Regulations > Article 28 the provisions of Party organizations in the disciplinary review But found that party members are stipulated in the criminal law, although not involved in a crime shall be investigated for Party discipline and responsibility should 31 be depending on the specific circumstances shall be given a warning until expelled punishment. This situation and a difference is that the former regulation behavior has been suspected of a crime, the feeling is quite strict, and the latter for the behavior not involving crime, only the objective performance of the provisions of the criminal code of behavior, but the plot is a crime to slightly. < Regulations > the 29 provisions, Party organizations in the discipline review found that party members and other illegal behavior, affect the party's image, the damage to the party, the state and the people's interests, we should depend on the situation Seriousness given disciplinary action. The loss of Party members, seriously damaging the party's image of behavior, should be given expelled from the party. At this article is party member is in violation of the criminal law outside the other illegal acts, such as violates the public security administration punishment law, customs law, financial laws and regulations behavior. The fourth is < cases > Article 32 stipulates, minor party members and the circumstances of the crime, the people's Procuratorate shall make a decision not to initiate a prosecution, or the people's court shall make a conviction and exempted from criminal punishment shall be given within the party is removed from his post, probation or expelled from the party. Party members and crime, sheets were fined in accordance with For acts; the principal Ordinance amended the provisions of the preceding paragraph. This is the new content, in order to achieve Ji method effective 32 convergence. Five is < > the thirty third article 10 of the provisions, the Party member due to an intentional crime is sentenced to criminal law (including probation) sheets or additional deprivation of political rights; due to negligence crime and was sentenced to three years or more (excluding three years) a penalty, shall give expelled punishment. Due to negligence crime is convicted and sentenced to three years (including three years) in prison or be sentenced to public surveillance, detention, shall in general be expelled from the party. For the individual may not be expelled from the party, should control Approval. This is followed and retained the original > < Regulations the provisions of punishment party authorization rules and report to a level party organizations. For is "party members with criminal acts, and by the criminal punishment, generally should be expelled from the party". The fifth chapter of probationary Party member of the discipline and discipline after missing members of the treatment and punishment decisions, such as the implementation of the provisions, clear the related party discipline and punishment decision made after, for duties, wages and other relevant alteration formalities for the longest time. 2, sub sub section will the original regulations of 10 categories of acts of violation of discipline integration revised into 6 categories, respectively, in violation of the punishments for acts of political discipline "in violation of discipline behavior of punishment" in violation of integrity of disciplinary action points "of violation punishments for acts 33 of mass discipline" "the violation of work discipline, punishment" in violation of discipline of life behavior punishment "6 chapters. 3, annex" Supplementary Provisions "clear authority making supplementary provisions of, cases of interpretative organ, as well as regulations implementation time and retroactivity etc.. 11 (3) learning understanding > < regulations needs to grasp several key problems The first problem -- about the violation of political discipline behavior > < new ordinance chapter 6 the political discipline column for the six disciplines, that is the main opposition to Party leadership and the opposition of the basic theory, basic line, basic program and basic experience, basic requirements of misconduct made provisions of the disposition, especially the eighteen since the CPC Central Committee put forward the Yan Mingzheng treatment of discipline and political rules requirements and practical achievements transformation for Discipline article, increase the false debate central policies, cliques, against the organization review, make no discipline of the principle of harmony terms. These are the party's eighteen years in comprehensive strictly Process combined with the practice of rich content. (1) false debate the central policies and undermine the Party of centralized and unified the problem is made in accordance with the provisions of the party constitution. Constitution in general programme requirements adhere to democratic centralism is one of the requirements of the construction of the party must adhere to the four cardinal. Application 34 of this principle is not only the party the basic organization principle and is also the mass line in party life, it requires that we must fully develop inner-party democracy, respect for the dominant position of Party members, safeguarding the Party member democratic rights, give full play to the enthusiasm and creativity of the party organizations at all levels and Party members, at the same time, also must implement the right concentration, ensure the party's mission < the chaos in unity and concerted action to ensure that the party's decision to get quickly and effectively implementing. The Party Central Committee formulated the major principles and policies, through different channels and ways, fully listen to the party organizations and Party members of the opinions and suggestions, but 12 is some people face to face not to say back blather "" will not say, after the meeting said, "" Taiwan does not say, and nonsense ", in fact, not only disrupt the people thought, some causing serious consequences, the damage to the Party of the centralized and unified, hinder the central policy implementation, but also a serious violation of the democratic system of principles. There is no doubt that shall, in accordance with the Regulations > 4 Specified in Article 6 to give the appropriate punishment. For did not cause serious consequences, to give criticism and education or the corresponding tissue processing. (2) about the destruction of the party's unity < New Regulations > the forty eighth to fifty second article, to damage Party's unity unified and violation of political discipline, punishment situation 35 made explicit provisions. Article 52 of the new "in the party get round group, gangs seek private gain, cliques, cultivate private forces or through the exchange of interests, for their own to create momentum and other activities to gain political capital, given a serious warning or withdraw from their party posts disposition; if the circumstances are serious, to give Leave a party to observation or expelled from the party. (3) on against the organization review of the provisions of the constitution, party loyalty honesty is party members must comply with the obligations. Members must obey the organization decision, shall not violate the organization decided encounters by asking questions to find organization, rely on the organization, shall not deceive the organization, against the organization. For example, after the investigation does not take the initiative to explain the situation, but to engage in offensive and defensive alliance, hiding the stolen money is against survey organization, is a violation of the behavior of political discipline. Article 24 of the original > < Regulations, although the provisions of the interference, hinder group review the behavior of the fabric can be severely or 13 Aggravated punishment, but did not put this kind of behavior alone as a discipline for qualitative amount of discipline. > < new regulations increase the Article 57, "anti organization review, one of the following acts, given a warning or serious warning; if the circumstances are relatively serious, giving removed from or placed on probation within the party post; if the circumstances are serious, give 36 expelled from the party: (a) on supply or forged, destroyed, transfer, conceal evidence; (II) to prevent others expose, providing evidence Material; (III) harboring co personnel; (4) to the organization to provide false information, to hide the fact; (5) the him against the acts of the organization review. "< rule > add this clause to the Constitution requires more specific, the previous no punishment in accordance with the definite list and put forward clear punishment in accordance with. (4) about organizing or participating in superstitious activities as < Regulations > about engage in activities of feudal superstition obstruction of social management order" violations of Article 164 the provisions, but according to the original < rule > only in disrupting production, work, social life order The case to be disciplinary treatment, in other words, alone make the feudal superstition, organize or participate in the activities of feudal superstition of, does not constitute a violation. Which is not consistent with the requirements of our party's political party. > < new regulations in this change is, superstitious activities on the political discipline, increase the Article 58, is the organization of Party members, in superstitious activities included in violation of the negative list of political discipline deserves punishment, which and Party members should adhere to the correct political principle, political standpoint and viewpoint is consistent. 14 the second question about organization and discipline violation behavior of democratic centralism is our The party's fundamental 37 organizational system. < New Regulations > Chapter 7 "in violation of the behavior of organizational discipline punishment" mainly for violation of democratic centralism, contrary to the "four obey the discipline behavior for source classification rules. Increased not in accordance with the relevant provisions or requirements to the organization for instructions to report on major issues; do not report truthfully report about personal matters; falsify personal archives; hide before joining the party serious mistakes; leading cadres in violation of the relevant provisions of the organization, will participate in the spontaneous formation of the old Xiang, Alumni Association, comrades in arms; to obtain illegal country residence abroad or foreign nationality, illegal for private frontier Documents such as discipline terms. (1) on the report truthfully report personal matters in 2010 the Central Committee of the Communist Party of China office, office of the State Council introduced < provisions on issues related to the leading cadres to report personal >, is clear about the request, deputy division level and above leading cadres should truthfully report changes in my marriage and spouse, children, moved to the country (territory), practitioners, income, real estate, investment and other matters, for failing to report, do not report, concealed and unreported, according to the seriousness of the case, giving criticism and education, and to make a correction within a time limit, shall be ordered to make a check, the commandment Jiemian conversation, informed criticism or jobs, free Post 38 processing, constitute violations, in accordance with the relevant provisions shall be given a disciplinary sanction. But since the original < Regulations > and there is no corresponding specific terms, the violation of the regulations, do not report, as a false report about personal matters, there is no corresponding disciplinary action terms, in practice it is difficult to operate. In this regard, in order to solve is not reported, as a false report about personal matters 15 asked censure, the new < Regulations > add the Article 67 of violation of personal matters related to reporting requirements, report truthfully report the clear punishment basis, making this kind of violation behavior is no longer free drilling for Exhibition on matters of personal checks to verify and supervision of cadres, discipline review provides a powerful discipline guarantee. (2) about the illegal organization, to fellow, alumni, friends of the war will < regulations stipulated in Article 68 of >, leading cadres of the party in violation of relevant provisions of the organization, will participate in the spontaneous formation of fellow, Alumni Association, comrade in arms to give the punishment according to the seriousness of the case. Here special needs note is three points: this provision for only the leading cadres ", reflecting the high requirements of leading cadres; second violation in 2002, the Central Commission for Discipline Inspection, the central Organization Department and the The relevant provisions of the General Political Department jointly issued the < off in leading cadres not to participate in 39 the initiative to set up "the villagers would be" alumni "" comrades in arms organization notice >. That is to say, to the spontaneous formation of fellow, Alumni Association, comrades in arms will constitute the premise of discipline is a violation of the provisions of this. The notification specified, leading cadres are not allowed to participate in the spontaneous incorporation of fellow, alumni, between comrades association would like the organization and shall not bear the sorority Human and the organizer shall not hold the corresponding position in the sorority; shall not borrow machine woven "network" and engage in kiss sparsely, round and round the gangs, but not "align" "Jieyi Gold Orchid" behavior. The third is to emphasize here that shall be organized to participate in the initiative to set up the villager, Alumni Association, comrades in arms. The so-called 16 spontaneous was established mainly means without registration. Therefore, Party members include leading cadres in the normal range of fellow, alumni, comrades in the party is not a violation of the rules of Party discipline. The three problem about integrity violations discipline Lian Jie discipline has been eighteen years clean government and anti The focus of the work of corruption. This Ordinance to amend, honesty and discipline this biggest adjustment, the new content, most of which prescribed by the original < criterion of a clean and honest administration > 8 ban and 52 are not allowed into the basic this part. (1) the central eight provisions of the spirit and requirements into < New > in 40 the regulations of the party's eighteen years, central resolutely implement the provisions of the eight and pay close attention to the node and intensive briefing, on public funds, private bus, public funds tourism, gifts of public funds, the big parade and lavish weddings and festive, illegal payment allowances and subsidies, illegal construction of buildings such as the original masses reflects the relatively strong, "four winds" problem of the Resolute rectification. But original < Regulations > to eat and drink, super standard reception and no clear and specific expression, new < rule > will implement eight Central provisions of the spirit of the problem increased to "clean cheap self-discipline" chapter, clear to exceed the standard, beyond the scope of the reception or borrow machine eating and drinking etc. some in violation of the provisions of the spirit of the eight central relevant persons responsible for punishment, once the violation will be according to the < rule > severely punished, binding, enhanced significantly. One is to add Article 87, about to obtain illegal, hold, and the actual use of the sports card, golf ball cards and other consumer card. Illegal access to private clubs made the punishment provisions. The second is increase the Article 97, has made provisions of the disposition of illegal self pay or 17 spamming allowances, subsidies and bonuses. The third is added to the Article 99, on violation of super standard, beyond the scope of the reception or borrow machine eat and drink to make the provisions of punishment. The fourth is to increase the Article 101, on the management 41 of conference activities in violation of the provisions made sanctions regulations. The fifth is the increased Article 102, for violation of office space management provisions made the punishment provisions. Six is to split the original < rule > Article 78, formed article 98, Article 100 of public Models of tourism, violate the provisions on the administration of the use of discipline of the bus through the list of made a more detailed provisions, apply more operational. Seven is increased the article 96, in violation of the relevant provisions of the, to participate in public funds to pay for dinner, high consumption of entertainment, fitness activities and public funds to buy gift, send gifts to make the provisions of the disposition. On the violation of the central provisions of the spirit of the eight, in addition to > < new regulations into "violation of honesty and self-discipline" misconduct outside, is different with the original < Regulations >, revised < rule > clearly defined not only to disposition of the directly responsible persons, but also dispose of collar Guide responsibilities. (2) increased trading rights, use of authority or position influence as relatives and close to profit violation of the terms of the < New Regulations > absorption < clean politics several guidelines > the relevant provisions spirit, increase the "negative list, including trading rights, the functions and powers or duties of influence as relatives and staff around profit. Increase Article 81" mutual use of office or authority ring for each other and their spouses, children and their spouses and other relatives, 42 around 18 personnel and other specific relationship between the people to seek benefits engage in trading rights, given a warning or serious warning Sanctions; if the circumstances are relatively serious, giving removed from or placed on probation within the party post; if the circumstances are serious, shall be expelled from the party. Increase Article 82 "connivance, acquiescence to the spouse, children and spouse etc. relatives and staff around the effect of Party members and cadres personal authority or position for personal gain, if the circumstances are relatively minor, given a warning or a serious warning; if the circumstances are relatively serious, giving removed from or placed on probation within the party post; if the circumstances are serious, the given Expelled from the party. Party members and cadres of the spouses, children and their spouses does the actual work and get salary or although the actual work but to receive significantly beyond the same rank salary standard, Party members and cadres informed fails to correct, in accordance with the provisions of the preceding paragraph. "(3) about the gifts, gifts misconduct from handling practices in recent years, engaged in official cadres received gifts, gifts problems more prominent. This has seriously affected the image of Party members and cadres, damaged the relations between the party and the masses, and is a hotbed of corruption, is really necessary for this kind of behavior to be disciplined. < rule > no on accepting gifts, gifts, Card consumption behavior to engage in simple "one 43 size fits all", but the difference between the different separately. One is in accordance with the provisions of Article 83, accepting may affect the impartial enforcement of the official gifts, gifts, consumer cards to depending on the seriousness of the case shall be given disciplinary sanctions. That is to say, for may affect the fair execution of business gifts, gifts, consumer cards are not allowed to accept. 19 is in accordance with the provisions of Article 83, accepting was significantly higher than normal ceremony is still exchanges of gifts, gifts, consumer card to disciplinary action. This is new regulations that daily life is purely reciprocity, accepting the same thing, boys , fellow friends gifts, gifts, shopping cards, although and fair execution of business has nothing to do, also want to as the case shall be dealt with, the situation is obviously beyond normal reciprocity ". The so-called" reciprocity ", one is emphasizes the reciprocal in protocol. In other words is you to me how, I to you how, not only does not go. The second is to significantly exceeded the normal local economy level, customs and habits, economic capacity of individual gifts, gift value. Specific sanctions to according to the processing of a variety of factors to consider, as appropriate. The third is the root according to the provisions of Article 84," to Engaged in public service personnel and their spouses and children, children's spouses and other relatives and other specific relationship presented Ming Xianchao normal reciprocity of gifts, gifts, consumer card, if the circumstances are 44 relatively serious, given a warning until probation. "In accordance with the above provisions, gift giving significantly beyond the normal reciprocity, giver constitute the discipline. (4) on illegal trading of stocks or of other regulations of securities investment < > Article 88 is engaged in punishment regulation of camp and activity in violation of the relevant provisions on. Among them, 3 will" buying and selling stocks or in other securities investment "column as one of disciplinary cases Out. First need to be clear, > < regulations did not change the provisions of the Ordinance. The ordinance of the provisions of the second paragraph of Article 77 provisions "who, in violation of the provisions of the sale of stocks" is one of the violation, and at the beginning of the first paragraph of this article "violation of 20 against the relevant provisions of the" textual representation of the repeat revision. In, just from the legislative technique removed the "personal" in violation of the provisions, content and not to change the original provisions. Need to clear is, "buy or sell a stock or of other securities investment" refers to violation of the relevant provisions refers to in April 2001, the Party Central Committee, the State Council promulgated the On the work of the party and government organs staff's personal investment in securities if dry provisions >. According to the provisions of Article 3, use of work time, office facilities, the sale of stocks and securities investment fund belongs to illegal behavior. The fourth question, about the violation of the masses of the disciplinary actions < 45 new regulations > would violate public discipline behavior of a single set of a class of restored "three rules of discipline and eight note" in the discipline of the masses of excellent traditional. < New Regulations > Chapter 9 "to violate the masses of disciplinary action", mainly the destruction of the party's close ties with the masses of misconduct made provisions on disciplinary; enrich and perfect the super standard, beyond the scope of Xiang Qun < All to raise fund and labor, in for involving the public affairs deliberately, chinakayao, in social security, policy support, disaster relief funds and materials and other matters assigned any kind and affectionate friends, obviously unfair acts against the interests of the masses of the disciplinary terms; increase the terms not in accordance with the provisions of the public party provided, government, factory and village (neighborhood) provided etc. violation of the people's right to know the behavior of the discipline. The fifth issue, on the violation of work discipline violation of work discipline added "negative list, including Party organizations carry out strictly Main responsibility for poor discipline terms. (1) the new party organization comprehensive strictly the main responsibility of the party does not fulfill the 21 or perform poor disciplinary terms < New Regulations > has a lead people to pay attention to the new terms, that is, in chapter ten "on the violation of work discipline behavior punishment" increase in the one hundred and fourteenth "party fail to perform 46 comprehensive strictly the main responsibility of the party or to perform comprehensive strictly the main responsibility for administering the ineffective, resulting in serious damage or serious adverse effects, to the person directly responsible and the responsibility of leadership and give a warning or serious warning. The situation is serious, giving removed from their party posts or on probation Punishment. "Here the changes. For the first time, the main responsibility write < rule >. (2) new shall report does not report or false reporting discipline shall increase the 117 bar" in the higher level units to check to inspect the work or report to the parent unit, work report of shall report the matters do not report or do not report, cause serious damage or serious adverse effects of, to the person directly responsible and the responsibility of leadership, to give warning or a serious warning; if the circumstances are serious, giving removed from their party posts or placed on probation. "For example, during the tour visits to the region, the unit Members the obligation to the inspection teams to reflect the true situation, to conceal not reported or intentionally to the inspection teams to provide false information, causing serious damage or serious adverse effects of, the person directly responsible and the responsibility of leadership should be in accordance with the provisions of < rule > Article 117 to give the appropriate punishment. (3) the new not granted in accordance with the provisions of punishment, not according to the provisions of the implementation of disciplinary measures 22 violation 47 of the provisions of Article 115 "Party organizations have one of the following circumstances, the direct leadership responsibility. Probation: members were sentenced punished, in accordance with the provisions give disciplinary action or in violation of state law Rules of behavior should be given disciplinary punishment and dispose of; disciplinary punishment by decision or complaint review the decision made, not in accordance with the provisions of the implementation decisions on punishment of the party, position, rank, and the treatment of the matters; Party members subject to disciplinary action, not in accordance with the cadre management authority and organizational relationships of by dispose of Party members to carry out education and supervision of daily management. "What needs to be pointed out is," cliff "demoted with cars, housing, secretary problem, implementation is not a discipline and party posts and ranks treatment by the organization department is responsible for the implementation, with cars, housing by the logistics department is responsible for the implementation of, Ji Commission responsible oversight responsibilities. The six questions, about the acts violating the discipline of life "in violation of discipline of life behavior punishment", mainly to "four winds" problems and a serious violation of social morality, family virtue acts of misconduct made provisions on disciplinary, an increase of extravagant life, contrary to the social public order and good customs disciplinary terms. Worth mentioning is, > < Regulations in Article 150 48 about "adultery" "mistress (Cardiff) formulation in the new < rule > is removed, to expand the scope of Article 127 provisions" and others hair improper sexual relations, let face disciplinary action Wider more strict. Four, and earnestly do a good job in the < code > and < rule > implement system of life lies in execution. < code > and < Regulations > is 23 Party organizations at all levels of a strong constraint and all Party members follow. Learning and implementing the < code > and < rule > is party committees (party), commission for discipline, discipline inspection group), the majority of Party members and cadres of the common responsibility, must party caught together, the party one execution. () Party committees (party) and play and implement comprehensive strictly the main responsibility, pays special attention to the two party regulations learning cross penetration. One is to Adhere to the party constitution is fundamental to follow, and resolutely safeguard the authority of the Party Chapter. The second is to adhere to the problem oriented, to strictly political discipline and political rule moments in the first place. The third is to adhere to the discipline and rules quite in front must not allow the bottom line to break the discipline. The fourth is to seriously organize the study of propaganda and education, in the city party members to create a disciplined, about the rules of the strong atmosphere. (II) Commission for Discipline Inspection at all levels (Discipline Inspection Group) to an important basis for the revised two party regulations as, adhere to easily 49 blame, strengthen supervision and enforcement And early method in combining Ji, increase accountability efforts. One is to two regulations within the party important basis, adhere to the party constitution duties, with strict discipline to maintain the constitution authority. The second is to adhere to high standards and keep the bottom line, adhere to Ji Yan in law and discipline, the discipline and rules quite in front, grasping grasping small, easily blame, comprehensive use of supervision and discipline of "four kinds of form" in the discipline embodies the strict requirements and care for the discipline, tighten up, Yan. According to discipline in accordance with regulations to carry out disciplinary review. Increase the violations punishment, clues can initiate an investigation on the trial of cases According to the discipline on the provisions of the proportion of processing and control manager maintains discipline. To focus on investigating non convergence, don't accept hand serious disciplinary violations at the same time, pay more attention to the general review of discipline 24 behavior, and gradually increase the lighter punishment. Four is to illuminate two party regulations, combined with the local district of the Department of party conduct Lianzheng to relevant laws and regulations system clean, timely research proposes to establish, change, waste release opinion, avoid conflict, and the fasten system of cage, and gradually formed not rot, not rot, not want to rot system and working mechanism. (3) the leadership of the party members and cadres 50 should play an exemplary role. The rate of higher consciousness of the front of the Ordinance to lead practice self-discipline norms, leading to maintain discipline of seriousness and authority. One is the above rate, demonstration and guidance, take the lead in learning and mastering the < code > and < > the requirements and regulations, do the deep understanding, learning to use. The second is to play an exemplary role in abiding by discipline rate, take the lead in practicing self-discipline norms, firmly establish before the discipline are equal, the system has no privilege, discipline is no exception, and consciously do standards, require more strict measures more practical. Third is to consciously accept supervision, conscientiously participate in the democratic life and debriefing honesty responsibility, such as Real to the party organization to report personal matters, and to accept the supervision of the work and life of the normal, habits under the supervision of the exercise of power, to carry out the work. The fourth is to set an example for the strict enforcement of discipline. Leading cadres should take the lead in the maintenance of discipline of seriousness and authority, to dare to seriously, dare to struggle, dare to offend people, for misconduct not laissez faire, but do not indulge, not tolerate to ensure the party constitution of party compasses party put in place. (4) the majority of Party members and cadres to set high standards and hold the bottom line, consciously abide by the < code > and < rule >. One is to control the < standard > and < 25 cases >, tight Close connection 51 with their own thoughts, practical work and life, efforts to solve the problems, to enhance the study and implement of the effectiveness and pertinence. The second is to establish a high standard and hold the bottom line, consciously in the self-discipline pursuit of high standards, strictly in the party away from the red line discipline, discipline, about the rules and know fear, distrust, the formation of the honor system, comply with the system, safeguard system of good habits. Regulations and discipline regulations of < < New Revision of the Communist Party of China clean fingered self-discipline criterion > and < Chinese Communist Party Disciplinary Regulations > is the Party Central Committee in the new situation to promote the comprehensive strictly root of the lift, the regulations of the party construction of keeping pace with the times. We should study and implement the Standards > and < > as the primary political task, adhere to the party constitution duties, adhere to the discipline of, Ji Yan in law, the full implementation of supervision and discipline accountability responsibilities for coordination and promotion "four overall" strategic layout in XX District vivid practice to provide a strong guarantee. - Si Jian Wu, and effectively enhance the implementation of the implementation of the < code > < > The consciousness of General Secretary Xi pointed out that the party is in charge of the party, to manage the party; strictly, it can cure good party. Criterion > and < rule > keep pace 52 with the times is our party to form a new potential strictly rules, to deepen understanding of the ruling law, is a comprehensive strictly, and strengthen the supervision within the party important grasper. Criterion > closely linked to the theme of self-discipline, self-discipline intensity-modulated, focusing on morality, for the majority of Party members and cadres set to see, feel the high standard, show the Communists noble moral sentiment; District Ordinance < < rule > the constitution of discipline integration into a political discipline, organization and discipline, honesty and discipline, discipline of the masses, work discipline, discipline, emphasize discipline, focusing on established rules, to draw the party organizations and Party members do not touch the bottom line. Party committees (party) to effectively strengthen the study and publicize the implementation of the < code > and < rule > the organization and leadership of criterion > and < > a full range, multi angle, deep publicity, the formation of study and publicize and implement the boom, in order to consolidate the development of good political environment to create a positive environment and atmosphere. The majority of Party members and cadres to strict requirements, the < rule > and < Ordinance cases > as a guide to action and behavior criterion, adhere to the moral standards and discipline of the bottom line, to maintain the discipline of worship and awe, learning, compliance, and maintain party discipline and rules of the model. The discipline inspection and supervision organs and cadres to the < code > and < > as the deepening of 53 the "three", and strengthen supervision and discipline of accountability is important to follow correctly grasp the use of supervision and discipline of "four types", promote the comprehensive strictly in new roots. Strict discipline, adhere to the discipline and rules quite in front of the enterprise in the implementation of expensive to implement to execute. The discipline inspection and supervision organs to implement the < code > and < Efforts to investigate cases > as an opportunity, adhere to the party should manage the party strictly, serious performance of their duties to promote two regulations implementation. Change discipline concept. From the simple "investigation of illegal" to a comprehensive "stare at violate discipline"; from the business case to prosecute the big cases and timely solve the signs of tilt to. From the orientation to the normal supervision; from the tube "minority" to resist the "most". Guide Party members and cadres to seriously implement the < code > and < rule >, consciously abide by the political, organizational, honest people, work, life six discipline. Urge the leadership cadres sent to play an exemplary role, take the lead in strictly enforced. Relaxation and rest Strong wind is Su Ji, closely linked to the "four winds" prone to multiple, the masses reflect the strong important nodes and, glued to the four winds "new form, new trends, seriously investigate and deal with violations of the central eight provisions of the spirit, to increase the bulletin exposure intensity, the formation of Chajiu" four winds "loudly, continue to release and discipline 54 must be strict signal. At the same time, extended supervision tentacles, through the development of the rural and fishery party conduct Lianzheng construction inspection, issued in a timely manner, Chajiu occurred in grassroots side of corruption and unhealthy, and earnestly safeguard the interests of the masses and social stability. The creativity and discipline. Grasp and make good use of the supervision and discipline of" four types ", to ensure the Promoting clues to lots of discipline and the law of the vacuum tube, strict together. Not only to the "less" and "very few" thorough investigation severely punished, but also the "most" to maintain zero tolerance trend through layers of conductive pressure, let the discipline about the rules for each party members and cadres consciously follow. At present, it is necessary to implement the "list" management, strictly follow the clues to the disposal of five standards, make the classification of disposal, dynamic cleanup. Zadok Party committees at all levels to implement the main responsibility, comprehensive use of disciplinary action and tissue processing and other means to effectively curb the commonplace, used to see do not blame the "small problem", not because of "practice" and "exception". Prominent Discipline characteristics, the problems of violation of discipline and rules into the focus of supervision and discipline and disciplinary review. At the same time, increase case double check the intensity, the serious problems of discipline violations or "four winds" ban but not absolutely, not only to be 55 held directly responsible, but also held leadership responsibility; not only to pursue studies the main responsibility of the Party committee, and to pursue Commission for Discipline Inspection and supervision responsibilities and promote accountability to become the new norm. The implementation of supervisory responsibility. Maintain < code > and < rule > the seriousness and authority of the discipline and rules and truly become the party's ruler. Discipline as supervision within the party the specialized agency, we must strengthen the responsibility to act, adhere to the Impartial discipline accountability, earnestly will be strict discipline, discipline must be punished, and severely punish the acts in violation of rules and regulations. 56