新法规下已上市化学药品生产批量变更政策解读及常见问题分析
Problems analysis and policy interpretation of changes to batch for chemical drug under the new regulations
周冲 1刘军田 1谢纪珍 1徐晓娟 1武海军 1马超2
作者信息
- 1. 山东省食品药品审评查验中心,山东 济南 250014
- 2. 山东省食品药品检验研究院,山东 济南 250101
- 折叠
摘要
目的 通过对已上市化学药品生产批量变更政策解读和山东省生产批量变更现状和常见问题进行分析,为相关单位开展生产批量变更研究工作提供参考.方法 对《已上市化学药品药学变更技术指导原则(试行)》中批量变更章节进行深入解读,对山东省已上市化学药品生产批量变更现状和常见问题进行汇总分析.结果 生产批量变更为《指导原则》实施后新增加的章节,且生产批量变更往往关联设备、工艺、参数、溶剂比例等生产过程中的各个方面,目前山东省生产批量变更的备案通过率有所改善,但申请人在对法规文件的理解上仍需提高.结论 新"两法"的实施,为申请人采用新技术、新设备,扩大产能,提高竞争优势提供了法规支持.药品上市许可持有人作为药品上市后变更管理的责任主体,应当全面关注批量变更中的关联变更,更科学的开展药品上市后变更研究.
Abstract
Objective This paper can provide reference for relative parties to carry out batch change research,based on analyzing the problems,the status quo and interpretating the policy in the process of batch change.Methods This paper deeply interpreted batch change of Technical Guideline for Making Post Approval Changes to Chemical Drug Products(Trial Implementation),and summarized the common problems and the status quo in the batch change of listed chemical drug in Shandong province.Results As the batch change added after the implementation of Technical Guideline for Making Post Approval Changes to Chemical Drug Products(Trial Implementation),batch change is usually relative to many aspects of the production process,such as equipment,process,parameters,solvent ratio and so on.Although the post-approval chemical drugs pass rate of the batch change is increased,but the understanding of the regulatory documents in applicants still needs to be improved.Conclusion The implementation of the New Regulations provid legal support for the application of new technology and new equipment,expanding production capacity,improving competitive advantage.As the main body of listed drug change researches,marketing authorization holders should pay more attention to associated changes in batch change,conduct change research more scientifically.
关键词
已上市化学药品/变更管理/批量变更/新法规Key words
Listed chemical drug/Change management/Batch change/New Regulations引用本文复制引用
出版年
2024
国家科技期刊平台
NSTL
万方数据