福建省近10年中药上市后变更的典型问题分析

Analysis of typical problems in post-marketing changes of traditional Chinese medicine in Fujian Province in past 10 years

中药上市后变更是已上市中药持续管理的重要环节,直接关系到中药的安全性、有效性、质量可控性,但以往中药上市后变更存在管理路径不清晰、研究验证欠缺等问题,不利于提升已上市中药的质量。对福建省近10年中药上市后变更研究资料进行回顾性分析,结合沟通交流案例、审评检查经验,梳理出中药上市后变更研究中存在的典型问题,并针对典型问题提出了关注中药变更的必要性及合理性、系统全面开展中药变更研究、完善中药变更相关指导原则、加强中西药复方制剂变更管理等建议。以期为药品上市许可持有人开展中药上市后变更研究和药监部门实施中药上市后变更监管提供技术参考。

Post-marketing change of traditional Chinese medicine is an important part of the continuous management of already listed traditional Chinese medicine,which directly affects the safety,effectiveness,and quality controllability of traditional Chinese medicine.However,in the past,post-marketing change of traditional Chinese medicine had problems such as unclear management paths and lack of research and verification,which were not conducive to improving the quality of already listed traditional Chinese medicine.To retrospectively analyze the research data on post-marketing change of traditional Chinese medicines in Fujian Province in the past 10 years,combined with communication cases and review and inspection experiences to sort out the typical problems in the research on post-marketing changes of traditional Chinese medicines,and puts forward suggestions such as paying attention to the necessity and rationality of the changes of traditional Chinese medicines,carrying out the research on changes of traditional Chinese medicines systematically and comprehensively,perfecting the guiding principles related to the changes of traditional Chinese medicines,and strengthening the change management of Chinese and western medicine compound preparations.In order to provide technical reference for marketing authorization holder to carry out post-marketing change research of traditional Chinese medicine and drug supervision departments to implement post-marketing change supervision of traditional Chinese medicine.