药品(制剂)变更产地研究的关键问题

Key Issues on Study of Drug(Preparation) Production Site Alteration

目的介绍药品(制剂)变更产地研究的关键问题和一般方法。方法根据笔者在《已上市化学药品变更研究的技术指导原则(一)》起草过程中对产地变更的体会,结合实际工作经验,梳理变更产地研究和技术评价的总体思路,对药品获准上市后制剂产地变更的关键问题进行探讨并举实例说明。结果药品变更产地首先需要注意从安全性、有效性和质量可控性方面对品种进行审查和分析;注意变更产地前后药品处方及制备工艺的一致性、药品质量和疗效的一致性。结论全面和综合评价各类变更对药品质量、安全性、有效性的影响是产地变更研究的基本思路,也是技术审评的基本原则。

Objective To introduce the general method and key issues on the study of drug（preparation） production site alteration.Methods With the author＇s experience in the process of drafting guidelines for production site alteration and practical work,the general idea for research and technology assessment of the origin change was combed.The key issues of drug（preparation） production site alteration after the drug was approved for market were discussed and explained with specific examples.Results In the first place,it was necessary to study and examine the varieties from aspects of safety,efficacy and quality controllability in the changed origins.Besides,it needed to pay attention to the consistency of drug prescription and preparation process and the consistency of drug quality and efficacy.Conclusion It is a basic idea to comprehensively and synthetically evaluate the influences on drug quality,safety and efficacy exerted by drug production site alteration of all kinds,which is also a basic principle for the technical review and evaluation.