在药品监管新要求下医疗机构中药新药开发的思考  

Considerations on Development of New Chinese Medicine Drug in Medical Institutions

作　　者：罗李娜[1] 陈更新[1] Luo Lina;Chen Gengxin(Guangdong Provincial Hospital of Chinese Medicine,Guangzhou 510120,China)

机构地区：[1]广东省中医院,广州510120

出　　处：《中国药事》2022年第3期251-255,共5页Chinese Pharmaceutical Affairs

摘　　要：目的:为推动医疗机构中药新药开发提供建议。方法:对近年来国家出台的一系列中药新药相关措施及指导原则进行总结,分析中药新药研发现状,探讨当前存在的问题。结果:医疗机构在中药新药开发中具有一定的优势,但在临床价值评估、收集人用经验证据等方面较欠缺。结论:应从完善临床疗效的指标评价体系、建立医疗机构中药制剂人用经验应用模式、有效利用真实世界证据、设计中药新药研发质量控制整体方法入手,才能加快医疗机构推进中药新药开发,促进中医药的创新发展。Objective:To provide recommendations for promoting the development of new Chinese medicine drug in medical institutions.Methods:A series of related measures and guiding principles of new Chinese medicine drug issued by the government in recent years were summarized.The present situation of development of new Chinese medicine drug was analyzed,the existing problems were discussed.Results:Medical institutions have certain advantages in the development of new Chinese medicine drug,but lack the clinical value evaluation,collection of empirical evidence for human use.Conclusion:In order to accelerate the development of new Chinese medicine and promote the innovative development of new Chinese medicine drug in medical institutions,we should improve the clinical curative effect of index evaluation system,establish human experience application mode of Traditional Chinese medicine preparation in medical institutions,effectively use real-world evidence and design overall methods of quality control on the development of new Chinese medicine drug.

关 键 词：中药新药 研究开发 医疗机构 中医药 创新发展 

分 类 号：R95[医药卫生—药学]