通过分析中药制剂生产工艺变更特点，梳理中药制剂生产工艺变更研究管理历史，调研中药制剂生产工艺变更现状，分析中药制剂生产工艺变更原因，为中药制剂生产工艺变更研究管理提供参考。认为目前对已发生的生产工艺变更管理尚缺乏有效的方法和途径，生产企业对生产工艺变更申报存在观望现象。建议基于科学和风险控制原则，采用更加灵活的生产工艺变更监管方式以适应中药制剂生产工艺变更特点，完善符合中药制剂特点的生产工艺变更技术要求。提出中药制剂生产工艺变更研究管理应立足于鼓励药品上市许可持有人围绕质量的均一稳定开展研究，促进中药制剂生产工艺变更科学、合理及中药制剂质量均一稳定。

To analyze the characteristics and reasons of production process changes of Chinese materia medica (CMM) preparations, study the history and research status on production process changes of CMM preparations, and provide reference for the management of production process changes of CMM preparations. It is considered that there is no effective solution for the management of production process changes of CMM preparations in the current status, so manufacturing companies take a wait-and-see attitude toward these changes. It is suggested that we should apply the risk-based approach and more flexible regulation pattern on production process changes to substitute the present regulatory method, at the same time, improve the technical requirements of production process changes according with the preparations characteristics and development of CMM preparations, and encourage marketing authorization holder to carry out research on the quality uniformity of products to manage the production process changes of CMM preparations, thereby promoting more scientific and rational on production process changes and ensuring the uniformity and stability of CMM preparations.