中国制药工业发展报告（2019）
书 名： 中国制药工业发展报告（2019）
英 文 名： ANNUAL REPORT ON THE DEVELOPMENT OF CHINA’S PHARMACEUTICAL INDUSTRY （2019）
作 者： 佘鲁林 温再兴 主编; 潘广成 曲继广 执行主编
I S B N： 978-7-5201-5062-0
丛 书 名：
关 键 词： 制药工业 工业发展 研究报告 中国
出版时间： 2019年07月
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中文摘要
《中国制药工业发展报告（2019）》是“制药工业蓝皮书”的第二本。全书共12大篇章，分别为总报告、医药改革篇、政策法规篇、行业发展篇、专题报告篇、科技创新篇、质量标准篇、绿色制药篇、信用建设篇、区域发展篇、国际交流篇和附录，围绕制药行业的发展及相关热点问题进行重点分析和研究。总报告对中国医药工业70年的发展进行了回顾；对2018年中国医药工业经济运行进行了分析；提出了2019年中国医药工业八项主要任务，预计通过2019年的发展，中国医药工业的产业结构将进一步优化，创新能力、质量安全和保障能力将提高到一个新水平。
医药改革篇阐述新时代医保改革发展的逻辑方向及战略目标。政策法规篇叙述了中国加入ICH始末及其重要意义，介绍了上市许可持有人制度试点现状。行业发展篇介绍科创板对生物医药行业的影响，阐述了原料药全产业链要素。专题报告篇对中国抗艾滋病原料药产量及市场价格进行了调研，对国际抗感染药物和肝素市场现状与发展进行了分析，解析了2018年股市投资医药制造行业状况。科技创新篇阐明了“青蒿琥酯”为中国医药卫生领域的创新药代表，介绍了创新医药企业的案例，概述了当今世界研究开发产品最新进展和前景展望，介绍了科创板给制药行业带来的重大机会。质量标准篇介绍了我国开展注射剂一致性评价的情况。对药用辅料登记和关联审评审批进行了回顾和展望，阐述了其历程，概述了企业建立输液质量指标控制的质量管理体系；分析了企业质量管理模式的核心。绿色制药篇介绍了企业连续反应技术成功运用于商业化生产的经验，阐述了原料药制造污染控制与治理策略，建立企业环境管理体系，介绍了绿色制药及其实现的路径。信用建设篇分析了医药行业信用管理的形势与使命，对涉医涉药领域拖欠款失信问题及治理进行了初步研究探讨。区域发展篇主要对上海市、河北省、四川省制药工业的发展及2018年经济运行情况进行了分析。国际交流篇对2018～2019年中国医药产业国际化形势进行了分析，阐述了借鉴美国、日本仿制药的发展经验，寻找中国仿制药的出路，使我国药企产品、管理等向国际标准靠近。附录主要内容为2018年化学原料药和化学药制剂产量情况，中国化学制药工业协会2018年品牌榜，2018年化学药主要产品产量情况分析。
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总报告
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医药改革篇
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政策法规篇
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行业发展篇
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专题报告篇
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科技创新篇
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质量标准篇
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绿色制药篇
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信用建设篇
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区域发展篇
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国际交流篇
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