已上市化学药品药学变更研究的基本技术考虑

Basic technical requirements for CMC changes of the post-approval chemical drugs

变更研究是药品全生命周期研究的重要内容,研究者应当参照相关技术指导原则,评估其变更对药品安全性、有效性和质量可控性的影响,进行相应的技术研究并按照《药品注册管理办法》的相关要求进行补充申请的申报。本文结合补充申请的审评情况,对已上市化学药品的药学变更研究的基本技术考虑进行了归纳,主要包括:立题合理性评估、变更事项及变更内容确定、变更风险分析、变更研究验证、结果评估等,供研究者从事变更研究参考。

Research on changes is the important content throughout the product lifecycle. The investigator should refer to the relevant technical guidelines, assess their changes on drug safety, efficacy and quality control of the impact, perform the corresponding technical research, and submit the supplementary application followed the ＂Drug Registration Regulation＂. In this article, based on the review of supplementary application, technical re- quirements for CMC changes of the post-approval chemical drugs were summarized providing references for indus- try, including drug reasonable assessment, changes in the content to determine, change risk assessment, change development and validation, evaluation results, etc.