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1、reform results, economy, and political system, and culture system, and social system, and discipline check system, and party of construction system reform solid advance, tax, and financial, and price, and administrative approval, and State-owned enterprises, and ecological civilization, important fi
2、eld and key link reform made major progress, market in resources configuration in the of decisive role significantly enhanced, Unprecedented burst of momentum and vitality of economic and social development. XI General Secretarys speech in this regard include the reform only when there is no complet
3、e, the notes on the 18 session of ideas into the partys spirit of the reforms more difficult to move forward, the increasing use of the Socialist system with Chinese characteristics such as the ability to run the country. 4. with regard to promoting sustained and healthy economic development. Face c
4、omplex changeable of international situation and difficult heavy of domestic reform development stable task, XI General Secretary made China economic development into new normal of science judge, proposed innovation, and coordination, and green, and open, and shared five big development concept, imp
5、lementation macro policy to stability, and industry policy to associate, and micro policy to live, and reform policy to real, and social policy to backing five big pillar sex policy, vigorously advance supply side structural reform, new concept, achieved has 2013 to 2015 during, Domestic production
6、total annual growth 7.3%, obviously fast Yu earlier world economic 2.3% of annual growth, on world economic growth of contribution over 25%, tertiary industry accounted for domestic production total share over 50%, eventually consumption on economic growth of contribution rate reached 66%, economic
7、structure adjustment made important progress, development of quality and benefits significantly upgrade, China economic show out huge of swing room and broad of development prospects. This aspects XI General Secretary of speech main including economic growth must is real and no water of growth impro
8、ve open type economic level see missing of hand and see have see of hand are to with good speed up from elements drive, and investment scale drive development mainly to to innovation drive development mainly of change active promoted China energy production and consumption revolution,. 5. with regar
9、d to building the rule of law in China. 18 big yilai, Central tightly around full advance law ruling, put party of led, and people masters, and law ruling organic unified up, insisted law ruling, and law ruling, and law administrative common advance, insisted rule of law national, and rule of law Go
10、vernment, and rule of law social one construction, full advance science legislation, and strictly law enforcement, and just judicial, and universal law-abiding, China features socialist legal system further sound perfect, leaders at all levels cadres using rule of law thinking and rule of law way de
11、epening reform, and附件3自体免疫细胞（T细胞、NK细胞）治疗技术管理规范（征求意见稿）为规范自体免疫细胞（T细胞、NK细胞）治疗技术临床应用，保证医疗质量和医疗安全，制定本规范。本规范为医疗机构及其医师开展自体免疫细胞（T细胞、NK细胞）治疗技术的最低要求。自体免疫细胞治疗技术是指从自体外周血中分离的单个核细胞经过体外激活和扩增后输入患者体内，直接杀伤肿瘤细胞或病毒感染细胞，或调节和增强机体的免疫功能。本管理规范适用于在临床上已完成安全性和有效性认证，并符合伦理要求，只涉及自体T细胞和NK细胞作为治疗手段的医疗技术。一、医疗机构基本要求（一）医疗机构开展自体免疫细胞（T细胞
12、、NK细胞）治疗技术，应当与其功能、任务相适应。（二）三级甲等医院，具有卫生行政部门核准登记的与应用自体免疫细胞（T细胞、NK细胞）治疗技术有关的诊疗科目。（三）具有与自体免疫细胞（T细胞、NK细胞）治疗相关的科室，科室人员组成包括有与开展人体免疫细胞（T细胞、NK细胞）治疗技术相适应的执业医师、执业护士、具有免疫学专业背景的专家和自体免疫细胞（T细胞、NK细胞）制剂制备技术人员；具备开展自体免疫细胞（T细胞、NK细胞）治疗技术的场地、设备和设施；具备从事自体免疫细胞（T细胞、NK细胞）治疗质量控制的专业检验科室和人员。（四）医院设有管理规范、运作正常的由医学、法学、伦理学等方面专家组成的自体
13、免疫细胞（T细胞、NK细胞）治疗技术临床应用与伦理委员会。（五）有至少2名具备自体免疫细胞（T细胞、NK细胞）治疗技术临床应用能力的本院在职医师，有经过自体免疫细胞（T细胞、NK细胞）治疗相关知识和技能培训的、与开展的自体免疫细胞（T细胞、NK细胞）治疗相适应的其他专业技术人员。二、人员基本要求（一）自体免疫细胞（T细胞、NK细胞）治疗医师1.取得医师执业证书，执业范围为开展本技术应用相关专业。2.有10年以上开展本技术临床应用相关专业临床诊疗经验，具有副主任医师及以上专业技术职务任职资格，在本医院连续工作不少于2年。3.经过卫生行政部门认可的自体免疫细胞（T细胞、NK细胞）治疗技术系统培训并
14、考核合格。（二）自体免疫细胞（T细胞、NK细胞）制备实验室人员1.制备自体免疫细胞（T细胞、NK细胞）实验室至少有1名副高级及以上专业技术职务任职资格的总体负责人，从事细胞制备的操作人员应具有相关专业（生物、免疫、检验和医学）大学（专）本科及以上学历，有不少于50例实验性免疫细胞制备经验，经专业技术培训并考试合格。2.从事质量检验的工作人员应具有相关专业大学（专）本科及以上学历，经专业技术培训并考试合格。（三）其他相关卫生专业技术人员经过自体免疫细胞（T细胞、NK细胞）治疗相关专业系统培训并考核合格。三、技术管理基本要求（一）细胞质量控制要求1.提供自体免疫细胞（T细胞、NK细胞）制剂制备的实
15、验室应具备省级以上药品监督管理部门和疾病预防控制中心认证的GMP制备室，有细胞采集、加工、检定、保存和临床应用全过程标准操作程序（SOP）和完整的质量管理记录。制定并遵循cGMP实验室维护标准操作程序（SOP）。2.自体免疫细胞（T细胞、NK细胞）制剂制备要求：体外操作过程的细胞培养成分和添加物（培养液、细胞因子、血清等）以及制备过程所用的耗材，其来源和质量认证，应符合临床使用的质量要求，原则上鼓励采用无血清培养基、自体血清或者自体血浆。不允许使用异种血清或者血浆。3.自体免疫细胞（T细胞、NK细胞）制剂制备质控标准：（1）细胞制品外源因子的检测包括：细菌、真菌、支原体和内毒素。参照现行版中国
16、药典生物制品相关规程进行。（2）细胞质量指标：每批细胞应注明来源并加以标记或确定批号；细胞数量应满足临床最低需求，存活率应不低于80%；纯度和均一性已达到临床应用水平；体外检测细胞具备正常功能和生物学效应，如细胞具有的某种生物学功能，分泌某种产物的能力，表达某种标志的水平等。无菌试验：每批培养的细胞在患者输注前均应进行无菌试验。建议在培养开始后34天起每间隔一定时间取培养液样品，包括患者回输前48小时取样，按现行版中国药典生物制品无菌试验规程进行。在患者使用前，取培养液及/或沉淀物用丫啶橙染色或革兰染色，追加一次污染检测。进行长期培养的细胞，应进行支原体检查。对每一批细胞终制剂应留样检测。如果留样发现阳性结果或发现几次阳性结果后，应及时对生产过程进行检查。如果在细胞
