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 manu-facture 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.
Research on the development strategy of small and medium-sized contract development and manufacturing organization under the background of domestic pharmaceutical policy reform
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.
marketing authorization holdercontract development manufacture organizationdevelopment strategydrug developmentpolicy reform
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