摘要
目的:为生产企业进行已上市化学合成原料药变更起始原料的风险评估及研究验证提供技术参考。方法:基于我国已上市化学药品变更相关法律法规、指导原则、技术指南等,结合日常药品审评工作经验及典型案例,对已上市化学合成原料药变更起始原料合成路线、供应商、质量标准等的相关技术要求及常见问题进行分析讨论,进一步梳理总结研究验证及风险评估的关注点。结果与结论:起始原料对原料药的质量有着直接且重要的影响,需要综合考虑多方面因素,如质量一致性、生产过程可控性、成本和供应链的稳定性等,并通过科学严谨的评估、研究和验证,确保变更不会对原料药的质量及对应制剂的安全性、有效性和质量可控性产生负面影响。
Objective:To provide technical reference for the risk assessment and research verification of the change of starting materials for chemical synthetic APIs.Methods:Based on the laws and regulations,guiding principles and technical guidelines related to the change of listed chemical drugs in China,combined with the daily drug evaluation experience and typical cases,the technical requirements and common problems related to the change of starting material synthesis route,suppliers and quality standards of listed chemical synthetic APIs were analyzed and discussed,and the concerns of research verification and risk assessment were further summarized.Results and conclusion:starting materials has a direct and important influence on the quality of active pharmaceutical ingredients,need to consider many factors,such as the quality consistency,production process control,cost,and the stability of the supply chain,etc.,and through scientific rigorous assessment,research,and validation,ensure that will not change the quality of active pharmaceutical ingredients and corresponding safety,efficacy and quality controllable preparation have a negative impact.
作者
侯瑾
刘福龙
李德宝
张平
徐晓娟
董爱梅
HOU Jin;LIU Fulong;LI Debao;ZHANG Ping;XU Xiaojuan;DONG Aimei(Shandong Center for Food and Drug Evaluation&Inspection,Jinan 250014,China)
出处
《山东化工》
2025年第3期125-127,共3页
Shandong Chemical Industry
