变更制剂所用原料药供应商的相关要求及常见问题分析

Analysis on Relevant Requirements and Common Problems Related to Change of Suppliers of API Used in Pharmaceutical Preparations

目的 对变更制剂所用原料药的供应商申报事项的相关要求和常见问题进行分析,以期降低申请人研究过程中的风险,供申报参考。方法 依据相关法律法规及指导原则的要求,结合日常技术审评经验,从多个方面分别予以阐述分析。结果 申请人在证明性文件、原料药质量对比研究、制剂质量对比研究和稳定性对比研究等方面仍存在一些问题。结论 建议申请人不断完善相关研究工作,提供充足的支持数据,以证明变更制剂所用原料药的供应商前后药品质量的一致性。

Objective To analyze the correlated requirements and common problems related to the change of suppliers of API used in pharmaceutical preparations,to reduce the risk in the process of research and provide reference for the applicant.Methods According to the requirements of relevant laws,regulations,and guiding principles,combined with daily technical review experience,the correlated requirements and common problems of the change of API suppliers are analyzed from multiple aspects.Results Some problems still exist in supporting documents,comparative study on quality of APIs and pharmaceutical preparations,and comparative study on stability.Conclusion It is proposed that the applicant should continuously improve the research work and provide adequate supporting data to prove the consistency before and after the change.