医疗机构制剂研制现状及创新发展路径分析  

Analysis on the Current Situation and Innovative Development Path of Pharmaceutical Preparations in Medical Institutions

作　　者：高敏洁 常云成 高静 Gao Minjie;Chang Yuncheng;Gao Jing(Shanghai Center for Drug Evaluation and Inspection,Shanghai 201203,China;Shanghai Medical Products Administration,Shanghai 200233,China)

机构地区：[1]上海药品审评核查中心,上海201203 [2]上海市药品监督管理局,上海200233

出　　处：《中国药事》2021年第9期1052-1059,共8页Chinese Pharmaceutical Affairs

摘　　要：目的:为推动医疗机构制剂创新发展提供建议。方法:通过问卷和现场调研,了解上海市医疗机构在医疗机构制剂研发和推动医疗机构制剂向市售药品转化方面的意愿,以及存在的困难和需求等。并以上海为例,分析医疗机构制剂创新发展路径。结果:上海市医疗机构研制医疗机构制剂的意愿不低,也有进一步开发新药的设想,但在人力、财力、能力等方面仍存在困难,需得到进一步的支持。结论:推动医疗机构制剂创新发展,需要多个部门给予鼓励、引导和服务。此外,可通过引导合理立项,加强一线医生教育,拓展开发模式,推动行业信息交流等,增强创新研究的动力,促进成果转化。Objective: To give recommendations for promoting the innovation and development of Pharmaceutical Preparations in Medical Institutions. Methods: Through questionnaire and on-site investigations,the willingness, existing difficulties and demands of medical institutions in Shanghai about developing new preparations in the medical institution and promoting them to the market were investigated. Then taking the situation in Shanghai as an example, the path of innovation and development of Pharmaceutical Preparations in Medical Institutions was analyzed. Results: The medical institutions in Shanghai are willing to develop new preparations, and also have the idea of further development of new drugs. But there are difficulties in the respects of human resources, financial resources and relevant capacities to conduct the research so that they need more supports. Conclusion: Promoting the innovation and development of Pharmaceutical Preparations in Medical Institutions requires encouragement, guidance and services from multiple departments. In addition, we could improve the motive force of innovative research and the transformation of achievements by guiding the rational establishment of projects, strengthening the education of front-line doctors, expanding the development mode and promoting the exchange of information in the industry.

关 键 词：医疗机构制剂 中医药 创新发展 药品注册 

分 类 号：R95[医药卫生—药学]