《中国医药产业高质量发展状况调研(2021-2023)》研究报告综述  

Research Overview of the High-Quality Development Status of the Pharmaceutical Industry in China(2021-2023)

作　　者：吴少祯 严文君 张燕玲 方剑春 马茗舒 方佳璇 茅宁莹[4] 李军[4] 陈秋佳 WU Shao-zhen;YAN Wen-jun;ZHANG Yan-ling;FANG Jian-chun;MA Ming-shu;FANG Jia-xuan;MAO Ning-ying;LI Jun;CHEN Qiu-jia(China Health Media Group;Healthy China Research Institute,China Health Media Group;Big Data Center,China Health Media Group;School of International Pharmaceutical Business,China Pharmaceutical University)

机构地区：[1]中国健康传媒集团 [2]中国健康传媒集团健康中国研究院 [3]中国健康传媒集团大数据中心 [4]中国药科大学国际医药商学院

出　　处：《中国食品药品监管》2024年第3期4-17,共14页China Food & Drug Administration Magazine

摘　　要：目的:了解“十四五”以来我国医药产业高质量发展转轨和运行状况,梳理监管政策在产业高质量发展转轨中的影响和作用,探讨医药产业迈向高质量发展进程中面临的挑战,对进一步深化医药产业高质量发展提出思考和策略建议。方法:通过文献研究、问卷调查、访谈、专家咨询等方式,获取相关政策信息、数据、业界观点等,同时组织专家研讨作为项目研究支撑。结果:我国医药产业积极应对经济下行压力,表现出了良好的产业发展韧性,新药审评上市数量、审评速度与新药临床价值都跃升到新高度,与此同时,中药行业发展表现相对突出,药品制造升级稳步推进,监管科学项目成果丰富。结论:我国医药产业正在以高质量发展转型为方向积极进行深度调整,目前已在研发创新、制造升级、中药守正创新等方面取得了积极进展,同时在研发策略与资金支持、中药传承创新、国际化发展、保障供应链稳定可控等方面仍然存在挑战,建议在进一步转变研发策略、建立多元化筹资体系、完善国际化配套政策、坚持中药特色监管、深化监管科学行动计划、强化监管能力建设、促进“三医”协同等方面发力,有效助推医药产业高质量发展。Objective:To understand the transition and operational status of China's pharmaceutical industry towards high-quality development since the 14th Five-Year Plan,analyze the influence and role of regulatory policies in this transition,discuss the challenges faced by the industry,and put forward strategic suggestions for further advancement.Methods:Through literature research,surveys,interviews,and expert consultations to obtain relevant policy information,data,industry views,etc.Expert discussion are organized to support the research.Results:China's pharmaceutical industry has actively responded to the economic downward pressure,showing a resilience in industrial development,with significant advancements in new drug evaluation and listing,traditional Chinese medicine development,and regulatory science projects.Conclusion:The pharmaceutical industry in China is actively adjusting deeply towards high-quality development and transformation.At present,positive progress has been made in research and development innovation,manufacturing upgrading and innovation of traditional Chinese medicine.However,there are still challenges in research and development strategy,funding,traditional Chinese medicine inheritance and innovation,internationalization,and supply chain stability.It is recommended to further transform research and development strategies,diversify financing system,improve international supporting policies,reinforce traditional Chinese medicine supervision,deepen regulatory science,strengthen the construction of regulatory capacity,and promote the Tripartite Cooperation of Medical Services to effectively promote the high-quality development of the pharmaceutical industry.

关 键 词：医药产业 高质量发展 创新 中药 药品制造 监管科学 

分 类 号：R95[医药卫生—药学]