摘要
目的:为药品上市许可持有人实施药品生产技术转让提供参考。方法:分析归纳2015年-2019年河南省药品生产技术转让申报资料中存在的主要问题,依据分析结果探讨药品生产技术转让项目实施的关注要点。结果与结论:对河南省161个药品生产技术转让品种申报资料中存在的问题进行分析归纳,存在问题主要集中在转出方产品资料、生产工艺及工艺验证、质量研究及质量标准、稳定性研究、原辅料及药包材等方面,结合发现的问题并综合实践经验及文献资料探讨药品生产技术转让项目实施的关注要点。
Objective:To provide references for marketing authorization holders who intend to implement drug technology transfer.Methods:The main problems existing in the technology transfer in Henan Province from 2015 to 2019 were collected and analyzed,and the key points of implementing technology transfer of drug production were discussed and summarized based on the analysis results.Results and Conclusion:The existing problems in the application materials of 161 drug production technology transfer varieties in Henan Province were analyzed and summarized.The existing problems lay mainly in the transferer’s product information,production technology and process verification,quality research and quality standards,stability research,raw materials,medicine packaging materials,etc.Based on the experience and the existing problems,the key points of concern for drug production technology transfer are summarized.
作者
张培
秦战勇
Zhang Pei;Qin Zhanyong(Henan Provincial Food and Drug Evaluation and Inspection Center,Zhengzhou 450008,China)
出处
《中国药事》
CAS
2021年第2期144-148,共5页
Chinese Pharmaceutical Affairs
基金
河南省科学技术厅2018年度科技攻关项目(编号182102310762)。
关键词
药品技术转让
上市许可持有人
技术转让要点
drug technology transfer
marketing authorization holders
key points on drug technology transfer
