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中国制药工业发展报告(2020)

书 名: 中国制药工业发展报告(2020)
英 文 名: ANNUAL REPORT ON THE DEVELOPMENT OF CHINA’S PHARMACEUTICAL INDUSTRY (2020)
作 者:  温再兴 潘广成 曲继广
I S B N: 978-7-5201-7063-5
丛 书 名: 制药工业蓝皮书 订阅
关 键 词:  制药工业 工业发展 药品管理
出版日期: 2020-09-01

中文摘要

《中国制药工业发展报告(2020)》全书共分7个篇章26篇报告,分别为总报告、政策法规篇、专题报告篇、科技创新篇、绿色制药篇、区域发展篇和附录。

总报告对2019年经济运行情况进行了分析,阐述了颁布新修订的《药品管理法》的重要意义;论述了医保目录调整、“4+7”药品带量集中采购对医药产业发展战略的影响;提出了2020年中国医药工业发展的10项主要任务。“三医联动”改革逐步进入深水区,医药产业面临结构调整转型升级的巨大变革,“创新·质量+合规”将成为医药产业发展的主旋律。

政策法规篇介绍了2019年版国家医保药品目录调整情况、管理的政策背景、需要解决的问题和目录调整的范围、重点、程序、监督机制等;阐述了新版《药品管理法》对于鼓励研发创新、保障药品可及性方面的举措和以信用管理为核心的药品新型监管模式;通过对部分典型国家创新药品医保政策的分析,对我国本土创新药品医保政策的完善提出了政策建议;解读了中国医药产业的发展。专题报告篇梳理了2019年以来注射剂一致性评价相关政策信息;预测了世界各个主要治疗药物的医药市场未来发展前景;具体分析了糖尿病药物市场、维生素C市场及抗血栓药物市场的情况;介绍了国外新批准上市的新制剂。科技创新篇讲述了创新是企业的核心竞争力及离心机产品五十年制造发展过程;以仿制药一致性评价申报资料中的常见问题作为切入点,解读官方发布的申报要求,根据多年仿制药研发与审评经验,给出一些参考建议;探讨高端制剂药用辅料(高端辅料)的研发方式和质量提高关键点,并对高端辅料的创新进行展望;介绍了高通量筛选 与AI辅助进化平台。绿色制药篇阐述了制药工业废水处理技术与实践,本着高浓度及特殊废水车间预处理、再混合统一处理的原则,提出了制药工业废水通用的治理技术路线;在高浓度抗生素生产废水残留抗生素效价概念的基础上阐述了通过强化水解预处理的方法将废水中抗生素效价消除后再利用生物与物化组合的方法进行常规污染物的去除的思路;介绍了电离辐照无害化处理抗生素菌渣的示范工程,电离辐照既可以降解菌渣中残留的抗生素,又可以杀灭耐药菌并消除抗性基因污染,从而实现抗生素菌渣的无害化处理;论述了抗生素菌渣的污染问题、无害化与资源化技术研发以及资源化产品的安全利用;介绍了陶瓷膜在发酵液澄清、中药精制及制药废水处理中的应用,分子筛膜用于溶媒脱水以及PDMS复合膜用于VOCs回收的现状;总结了我国环境中痕量抗生素赋存现状,探讨膜分离技术在抗生素废水的应用,并对新型复合膜在抗生素废水应用领域的使用进行展望。区域发展篇介绍了2019年广东省医药制造业发展情况,重点介绍了广东省医药制造业规模以上企业和化学制药工业2019年经济运行状况;介绍了陕西医药工业的发展历程和取得的成就,总结了产业发展中存在的问题,分析了发展优势,展望了产业转型方向。附录主要内容为2019年化学原料药大类产量供应出口量情况及2019年化学药制剂重点剂型产量情况,中国化学制药工业协会2019年品牌榜。

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