中国制药工业发展报告（2021）
书 名： 中国制药工业发展报告（2021）
英 文 名： ANNUAL REPORT ON THE DEVELOPMENT OF CHINA’S PHARMACEUTICAL INDUSTRY （2021）
作 者： 刘敬桢 温再兴 潘广成 曲继广
I S B N： 978-7-5201-8743-5
丛 书 名：
制药工业蓝皮书
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关 键 词： 制药工业 工业发展 创新发展
出版日期： 2021-09-01
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中文摘要
本报告认为，中国制药工业“十四五”面临的任务主要是：推动行业向创新驱动发展转型，加强药品供应保障能力建设，推进企业重组整合，夯实原料药产业基础，提高医药先进制造水平，实施制剂国际化战略。
到2025年制药工业的发展目标是：创新能力显著增强，产品质量全面提高，供应保障体系更加完善，国际化步伐持续加快，化学制药工业整体素质大幅提高。
本报告认为，仿制药质量和疗效一致性评价与药品集中带量采购是医药行业和企业当前及今后一个时期关注的重点和焦点。盘点本年度影响医疗健康领域发展的十大关键词是：新冠肺炎疫情，医保改革，DRG/DIP，集采与国谈，医疗改革，医药改革，中医药，互联网医疗，商业健康险，资本市场改革。在此基础上本报告分析总结了医疗健康领域发生的几个重要变化和未来发展趋势——规模制胜、差异化创新和消费升级，这些变化将影响行业竞争格局发生快速、持续的分化。阐述了新药研发阶段的EHS管理要求，从产品、工艺开发源头注重环保和安全问题，树立清洁生产的理念，推动绿色化学技术的应用，降低从业人员的职业健康风险；论述了医药企业合规管理的重要性、必要性。
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