Exploration and thinking on the cooperation process between MAH and CDMO in China
中国药品上市许可持有人制度（MAH）和合同研发生产组织（CDMO）合作流程探索及思考

摘要

通过介绍MAH和CDMO双方经历了初期、中期和上市三个合作阶段，开始于安全、质量审计，以及CDMO的研发能力和产能匹配，达成合作后，双方签订研发协议、生产协议和质量协议，建立各自健全的文件管理系统，并实施产品技术转移，后面产品获批上市后转入日常体系运行，正常生产供货需要安排驻厂监督，实行物料、产品出厂及上市放行。以期为中国MAH制度的持续完善，以及MAH和CDMO长久合作模式的探索提供思路和参考。

Abstract

Through the introduction of MAH and CDMO both experienced early, middle and listing three stages of cooperation, and began in safety, quality audit, and research and development capabilities and production capacity matching CDMO reached cooperation, the two sides signed the agreement on research and development, production and quality agreements, establish their improve the file management system, and implementation of product technology transfer, After the subsequent products are approved to be listed, they will be transferred to the daily system operation. The normal production and supply shall be supervised by on-site supervision, and the delivery and release of materials and products shall be carried out. It is expected to provide ideas and reference for the continuous improvement of Chinese MAH system and the exploration of long-term cooperation mode between MAH and CDMO.