《中国新药杂志》伴随改革开放的步伐已经走过了27年的历程，忠实记录了我国新药研发与注册审评的历史。自2014年起我们开始编纂《中国新药注册审评技术》，每两年出版一次，受到业界广泛欢迎。应广大读者要求，今年再次出版此书并更名为《中国新药注册审评双年鉴（2016-2017）》。本书汇集了2016-2017年中国新药杂志上发表的注册审评相关论文，包含了政策制定的思路、注册审评的指导原则、新药研发与注册审评的前沿技术。

本书的大多数作者来自国家食品药品监督管理总局药品审评中心的审评员，还有一部分来自中国食品药品检定研究院系统的研究人员，以及大学、科研单位、临床试验机构等作者。全书分为三章，第一章注册与审评管理，第二章 临床前研究审评技术，第三章 临床研究审评技术。本书最后的附录，列出了2016-2017年国家食品药品监督管理总局发布的新药注册审评相关政策，还收录了国家食品药品监督管理总局药品审评中心发布的“2016年药品审评年度报告”和“2017年药品审评年度报告”。本书具有专业性、政策性、时效性、实用性的特点，对新药研发、新药注册、新药审评、临床应用的专业人员具有一定的参考意义。

目  录

第1章　注册与审评管理

1．我国《药品注册管理办法》修订工作及有关思考····························· 张晓东，王庆利，周跃华，等

2．药品审评中心解决化学仿制药注册申请积压工作汇总及分析··················· 陈　新，黄清竹，温宝书

3．近年我国化药创新药注册申请情况分析·················································· 张晓东，王宏亮，杨志敏

4．化学仿制药新法规对研发及注册管理的影响分析································································ 蒋　煜

5．全球卫生治理下的《与贸易相关的知识产权协定》中弹性条款与药品可及性问题研究

··················································································································· 王　丹，赵英希，唐　昆

6．解决药物可及性的组合策略初探······················································ 耿文军，吴　斌，邓声菊，等

7．美国突破性治疗及其对我国新药审评的启示························································· 袁　林，邵明立

8．关于医疗机构中药制剂向中药新药转化的思考································· 李　灿，丁建华，刘　春，等

9．药品审评专家咨询制度研究与改革建议································································ 史继峰，陈韬卉

10．日本医药品医疗器械综合机构咨询制度及对我国的启示······································ 宋琳琳，邢　花

11．美国FDA药品审评保密政策及启示····································································· 袁　林，邵明立

12．药物临床试验数据公开制度研究及启示················································ 杨　莉，田丽娟，林　琳

13．我国新药优先审评模式研究··························································· 丁锦希，李苏菊，姚雪芳，等

14．欧盟的优先药物激励制度研究······················································· 邵　蓉，孙海顺，颜建周，等

15．美国药品审评正式争议解决程序评介及对我国的启示··························· 耿晓雅，魏天颖，马　坤

16．成人用药数据外推至儿科人群的技术要求及审评考虑···················· 孙艳喆，耿　莹，赵德恒，等

17．国外儿科药物研发的监管要求和研发策略································· 黄芳华，王庆利，Jim Ridings，等

第2章　临床前研究审评技术

2.1　非临床安全性评价

18．儿科用药非临床安全性评价中方案设计的策略···················································· 孙祖越，周　莉

19．对儿科药物开发的非临床安全性评价的考虑····························· 黄芳华，王庆利，Jim Ridings，等

20．非临床安全性评价中离乳前给药的幼龄动物分组设计········································· 周　莉，孙祖越

21．幼龄动物毒理学研究：试验设计、实施和结果分析·················· 黄芳华，王庆利，JIM Ridings，等

22．组织交叉反应试验在非临床安全性评价中的应用及案例分析·········· 余珊珊，王海学，胡晓敏，等

23．药物雄性生殖毒性评价考虑要点及FDA相关指导原则介绍············· 张立将，黄芳华，王庆利，等

24．对CFDA新版《药物刺激性研究技术指导原则》的解读及改进建议···································· 金　毅

25．心脏安全药理学评价新策略——CiPA·············································· 胡晓敏，张子腾，宗　英，等

26．直接抗丙肝病毒新药中的生殖毒性研究评价·································· 于春荣，笪红远，单晓蕾，等

27．直接抗丙肝病毒新药的致癌性研究评价················································ 于春荣，笪红远，王庆利

2.2　化学药物审评

28．关于我国化学药品技术指导原则体系有关问题的探讨······················································· 姜典卓

29．改良型新药非临床研究的一般考虑及需要关注的问题···················· 戴学栋，孙　涛，黄芳华，等

30．化学仿制药新申报资料要求简介······················································································· 黄晓龙

31．化学药品注册中对照品的技术要求······················································· 任连杰，张　宁，陈　震

32．关于化学药品注册批量问题的探讨····································································· 王宏亮，陈　震

33．对药用辅料与药品关联审评审批申报资料要求的解读与思考·········· 任连杰，马玉楠，蒋　煜，等

34．制备工艺和过程控制对合成多肽药物有关物质的影响································ 胡玉玺,蒋　煜,韩天娇

35．皮肤科药物研发中的若干问题解析····································································· 张星一，田　娜

36．皮肤外用半固体制剂体外透皮吸收对比试验常见问题分析················································ 田　洁

37．印度生物仿制药监管政策分析············································································ 刘　亮，楼铁柱

38．美国仿制药审评审批制度的经验分析与研究······················································· 雷继峰，杨建红

2.3　生物药物审评

39．生物制品质量标准研究与建立一般原则的探讨···················································· 李　敏，常卫红

40．从“质量源于设计”角度浅谈多糖-蛋白结合疫苗药学研发的考虑······················ 李　敏，许嘉齐

41．基因改构减毒活疫苗环境影响分析的考虑······································ 陈庆华，李　敏，罗建辉，等

42．双特异性抗体药物非临床研究的考虑要点······································ 闫莉萍，张　旻，王庆利，等

43．抗肿瘤抗体偶联药物非临床药理毒理研究的考虑要点··························· 闫莉萍，王海学，王庆利

44．微生物药物生产工艺研究的基本考虑·································································· 刘宗英，马　磊

45．欧盟生物类似药注册监管政策实施效果及启示···················································· 陈永法，伍　琳

46．FDA证明生物类似药与参照药可互换的考虑要点···························· 胡晓敏，宗　英，高晨燕，等

47．浅谈美国FDA有关疫苗的加速审批及动物法则······································ 陈庆华，罗建辉，王佑春

2.4　中药审评

48．中药新药研发策略分析·································································· 王　停，周　刚，赵保胜，等

49．试谈中药新药质量标准制定的整体思路············································································ 张永文

50．关于中成药说明书成份项表述的思考·································································· 韩　炜，周跃华

51．中药新药注册生产现场检查案例分析及建议········································· 贾　娜，曹　轶，李　乐

52．近年申请注册的中药新药生殖毒性研究情况及有关问题分析············································· 张晓东

第3章　临床研究审评技术

3.1　临床试验设计

53．药物临床试验中的安全评价 ·············································································· 曹　烨，万帮喜

54．我国药品监管中的生物统计学技术审评 ········································ 王　骏，曾　新，潘建红，等

55．新药临床开发过程中性别差异影响的考虑和研究策略 ··················· 魏敏吉，赵德恒，王水强，等

56．基于儿童用药供需平衡的儿科药物临床试验状况评价 ········································ 刘靖杰，杨　悦

57．浅谈新法规实施对疫苗临床试验的影响及挑战 ···································· 黎明强，吕榜军，覃彦香

58．人乳头瘤病毒疫苗国外注册的关键性临床试验简介························ 艾　星，王朝云，杨志敏，等

59．毒性中药复方临床安全性再评价的思考········································· 严　妍，吴　娟，焦月华，等

60．药物临床试验中疗效评价指标及常见评价方法·································································· 刘炳林

61．适应性设计在新药临床试验中的应用············································· 肖意可，胡飞芳，刘中强，等

62．《中药新药治疗恶性肿瘤临床研究技术指导原则》修订过程及解析······················ 李　杰，林洪生

63．对于《中药、天然药物治疗女性更年期综合征临床研究技术指导原则》的考虑和分析

································································································································· 裴小静，杨　娜

64．关注中药新药临床研究中的心脏安全性········································· 朱贤慧，刘炳林，唐健元，等

65．对《中药新药治疗中风临床研究技术指导原则》中疗效评估的解读···················· 石　进，王科花

66．中成药治疗功能性消化不良临床试验方案及研究病历设计和实施   李　博，赵迎盼，高　蕊，等

67．中药新药临床试验报告撰写常见问题分析········································································· 薛斐然

3.2　临床试验管理

68．我国药物临床试验监督和管理的方法探讨······································ 高建超，黄云虹，杨　焕，等

69．药物临床试验机构风险管理模式探讨············································· 黄一玲，许　莉，康　健，等

70．中药新药Ⅰ期临床试验病房管理及护理········································· 黄淑云，吴　萍，赵兰英，等

71．中药临床研究ARO-CRO项目管理运行模式探讨····························· 李　睿，唐旭东，陆　芳，等

72．对欧盟临床试验法规Reg.（EU）No 536/2014的解读与思考··········· 魏芬芳，孙宇昕，冷金诺，等

73．公众对临床研究认知的调查分析及培训方案探讨··························· 徐  岩，张晓方，李海燕，等

74．药物临床试验中的知情同意常见问题及分析·································· 赵淑华，刘晓红，傅志英，等

75．药物临床试验痴呆弱势群体与权益保障伦理学问题研究················· 曾令烽，刘　军，潘建科，等

76．临床研究中艾滋病受试者权益保护的主要问题和对策···················· 郑　君，杨志云，李　鑫，等

77．创新药物临床试验风险与受试者保护·································································· 钟　皎，王丽萍

78．关于在药物临床试验过程中保护精神类受试者权益的考虑············· 常麦会，耿　莹，赵德恒，等

79．专职药师在临床试验用药品管理中的重要作用······························· 唐铭婧，梅和坤，江学维，等

80．研究者发起的临床研究的风险评估及伦理审查······························· 江学维，曹　江，梁蓓蓓，等

81．《国家食品药品监督管理总局关于发布药物临床试验数据现场核查要点的公告》解读

············································································································ 彭　朋，元唯安，胡薏慧，等

82．美国FDCA框架下临床研究者造假的刑事责任研究·············································· 袁　丽，杨　悦

83．国际多中心临床试验监管指南研究报告········································· 张晓方，黄　丹，王翔宇，等

附　　录

2016年总局下发的注册审评文件目录

2017年总局下发的注册审评文件目录