国内药政改革背景下中小型合同研究生产组织的发展战略探索  

Research on the development strategy of small and medium-sized contract development and manufacturing organization under the background of domestic pharmaceutical policy reform

作　　者：吴晓燕 黄哲[1] WU Xiao-yan;HUANG Zhe(Shenyang Pharmaceutical University,Shenyang 110179,China)

机构地区：[1]沈阳药科大学,沈阳110179

出　　处：《中国新药杂志》2024年第11期1089-1092,共4页Chinese Journal of New Drugs

摘　　要：通过研究当前国内药品管理相关制度,对国内合同研究生产组织(contract development manufacture organization,CDMO)的发展现状和问题进行分析,为中小型CDMO的发展战略提出建议。研究结果表明适合中小型CDMO的发展战略包括:选择特色化发展道路,打造高技术壁垒的平台;持续完善质量管理体系;引进和培养专业技术人才和管理人才;加强外部联盟与合作。Suggestions on development strategy are provided to small and medium-sized contract development manufacture organization(CDMO)by studying current domestic drug management regulations.The development status and problems of domestic CDMO are analyzed.The research results show that the development strategies suitable for small and medium-sized CDMO include:choosing a characteristic development path,creating a platform of high technical barriers;continuously improving the quality management system,introducing and training a professional and technical personnel and management personnel,and strengthening the external alliance and cooperation.

关 键 词：药品上市持有人制度 合同研究生产组织 发展战略 药品研发 药政改革 

分 类 号：R95[医药卫生—药学]